Colorectal Carcinoma, Non-small-cell Lung Cancer, Ovarian Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma
Conditions
Keywords
PD-1, immune checkpoint inhibitor, IL-15, IL-2, cytokine, immunotherapy, Metastasis, advanced solid tumor, metastatic solid tumor
Brief summary
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Interventions
BIOLOGICALPF-07209960
PD-1 targeted IL-15 mutein
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological/cytological diagnosis of selected locally advanced or metastatic solid tumor * Demonstrated radiographic progression on most recent tumor assessment imaging * Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated * Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2 * Adequate hematologic, renal, liver, and coagulation functions * LVEF ≥50% by echocardiogram or MUGA * Resolved acute effects of any prior therapy * Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy * Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.
Exclusion criteria
* Known active symptomatic brain or leptomeningeal metastases requiring steroids. * Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation therapy within 4 weeks prior to planned first dose * Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose * Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose * Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible) * Active COVID-19/SARS-CoV2 * Anticoagulation with vitamin K antagonists is not allowed * Active bleeding disorder in the past 6 months prior to first dose * History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy) * History of interstitial lung disease or pneumonitis * Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant * Pregnant or breastfeeding female participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). |
| Number of Participants With Maximum Grade 3 or 4 TEAEs | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported. |
| Number of Participants With TEAEs Leading to Death | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | TEAEs were those events with onset dates occurring during the on-treatment period. |
| Number of Participants With Serious TEAEs | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. |
| Number of Participants Discontinued From Study Due to TEAEs | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). |
| Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. |
| Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. |
| Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) | The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. |
| Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (28 days) | For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Antidrug Antibody (ADA) Categories | on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT) | Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted). |
| Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT) | Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n2=Number of ADA-positive participants. |
| Number of Participants by Anti-IL-15 Wild Type NAb Categories | on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT) | Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (NAb) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced). |
| Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | Baseline through up to 2 years or until disease progression | TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events |
| Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response | Baseline through up to 2 years or until disease progression | DOR is defined as the time from first documentation of CR or PR to date of first documentation of objective progression, or death due to any cause, or time of censoring, whichever occurred first. |
| Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | Baseline through up to 2 years or until disease progression | PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause, or censoring, whichever occurred first. Both new anti-cancer therapy given prior to PD or death and no PD by the end of follow-up are censoring events. |
| Percentage of Participants With Disease Control Based on Investigator Assessment | From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately) | Disease control rate (DCR) is defined as the percentage of participants with a BOR of CR, PR, non-CR/non-PD or SD. |
| Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months) | Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis \<10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions. |
Countries
United States
Participant flow
Recruitment details
The study were planned to have 2 parts: a single agent dose escalation (Part 1) followed by a dose expansion (Part 2). Due to the early termination of the study, Part 2 study was never initiated and the overall study consisted of only Part 1. The data displayed are from the Part 1 study which is the only 1 period of the study.
Pre-assignment details
A total of 37 participants were enrolled and assigned to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| PF-07209960 1 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months. | 4 |
| PF-07209960 3 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months. | 4 |
| PF-07209960 10 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. | 4 |
| PF-07209960 15 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. | 3 |
| PF-07209960 20 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. | 16 |
| PF-07209960 30 mg SC Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. | 6 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Global deterioration of health status | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 2 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Progressive disease | 2 | 2 | 2 | 3 | 9 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | PF-07209960 1 mg SC | PF-07209960 3 mg SC | PF-07209960 10 mg SC | PF-07209960 15 mg SC | PF-07209960 20 mg SC | PF-07209960 30 mg SC | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous Mean | 67.0 Years STANDARD_DEVIATION 14.49 | 60.5 Years STANDARD_DEVIATION 15.33 | 60.8 Years STANDARD_DEVIATION 7.41 | 54.0 Years STANDARD_DEVIATION 4.58 | 56.6 Years STANDARD_DEVIATION 11.14 | 54.8 Years STANDARD_DEVIATION 13.92 | 58.1 Years STANDARD_DEVIATION 11.65 |
| Age, Customized 18-44 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Age, Customized 45-64 years | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 3 Participants | 24 Participants |
| Age, Customized >=65 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 11 Participants | 4 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 12 Participants | 5 Participants | 30 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 9 Participants | 1 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 7 Participants | 5 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 1 / 4 | 1 / 4 | 1 / 3 | 3 / 16 | 1 / 6 |
| other Total, other adverse events | 4 / 4 | 2 / 4 | 3 / 4 | 3 / 3 | 16 / 16 | 5 / 6 |
| serious Total, serious adverse events | 3 / 4 | 3 / 4 | 1 / 4 | 1 / 3 | 13 / 16 | 5 / 6 |
Outcome results
Primary
Number of Participants Discontinued From Study Due to TEAEs
Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to all-causality TEAEs | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants Discontinued From Study Due to TEAEs | Participants discontinued from study due to treatment-related TEAEs | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.
Time frame: Cycle 1 (28 days)
Population: The DLT analysis set was a subset of the safety analysis set. A participant was classified as DLT-evaluable if he/she experienced a DLT or received 100% of the planned doses and had received all scheduled safety assessments during the DLT window.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 3 Participants |
| PF-07209960 30 mg SC | Number of Participants With Dose Limiting Toxicities (DLTs) | 3 Participants |
Primary
Number of Participants With Maximum Grade 3 or 4 TEAEs
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 3 Participants |
| PF-07209960 3 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 2 Participants |
| PF-07209960 3 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 11 Participants |
| PF-07209960 20 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 8 Participants |
| PF-07209960 30 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (treatment-related) | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With Maximum Grade 3 or 4 TEAEs | Participants with Maximum Grade 3 or 4 TEAEs (all-causality) | 5 Participants |
Primary
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 2 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 2 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 2 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 2 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 3 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 2 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 2 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 9 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 14 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 12 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 15 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alkaline phosphatase increased | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyperkalemia | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypokalemia | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoalbuminemia | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Blood bilirubin increased | 2 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypercalcemia | 2 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Creatinine increased | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hyponatremia | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Aspartate aminotransferase increased | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypoglycemia | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypomagnesemia | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Alanine aminotransferase increased | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hypocalcemia | 0 Participants |
Primary
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypernatremia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypomagnesemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alanine aminotransferase increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypermagnesemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyperkalemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Blood bilirubin increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Alkaline phosphatase increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Aspartate aminotransferase increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypokalemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypocalcemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hyponatremia | 2 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Creatinine increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoglycemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypercalcemia | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hypoalbuminemia | 1 Participants |
Primary
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 3 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 4 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 2 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 4 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 4 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 2 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 2 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 4 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 10 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 6 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 15 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 13 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 16 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | INR increased | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | White blood cell decreased | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count increased | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Neutrophil count decreased | 3 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Fibrinogen decreased | 2 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Anemia | 6 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Platelet count decreased | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period | Lymphocyte count decreased | 6 Participants |
Primary
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 2 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 4 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 16 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 2 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | INR increased | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | White blood cell decreased | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Hemoglobin increased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Fibrinogen decreased | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Neutrophil count decreased | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Anemia | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Leukocytosis | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Platelet count decreased | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Activated partial thromboplastin time prolonged | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period | Lymphocyte count decreased | 6 Participants |
Primary
Number of Participants With Serious TEAEs
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 3 Participants |
| PF-07209960 3 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 13 Participants |
| PF-07209960 20 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 7 Participants |
| PF-07209960 30 mg SC | Number of Participants With Serious TEAEs | Participants with all-causality serious TEAEs | 5 Participants |
| PF-07209960 30 mg SC | Number of Participants With Serious TEAEs | Participants with treatment-related serious TEAEs | 4 Participants |
Primary
Number of Participants With TEAEs Leading to Death
TEAEs were those events with onset dates occurring during the on-treatment period.
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 2 Participants |
| PF-07209960 20 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants With TEAEs Leading to Death | Participants with all-causality TEAEs leading to death | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants With TEAEs Leading to Death | Participants with treatment-related TEAEs leading to death | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
Time frame: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 4 Participants |
| PF-07209960 3 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 2 Participants |
| PF-07209960 3 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 4 Participants |
| PF-07209960 10 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 3 Participants |
| PF-07209960 10 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 2 Participants |
| PF-07209960 15 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 3 Participants |
| PF-07209960 20 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 14 Participants |
| PF-07209960 20 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 16 Participants |
| PF-07209960 30 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 6 Participants |
| PF-07209960 30 mg SC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 6 Participants |
Secondary
Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response
DOR is defined as the time from first documentation of CR or PR to date of first documentation of objective progression, or death due to any cause, or time of censoring, whichever occurred first.
Time frame: Baseline through up to 2 years or until disease progression
Population: The full analysis set included all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07209960 1 mg SC | Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response | 9.5 Months |
| PF-07209960 3 mg SC | Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response | 3 Months |
Secondary
Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n2=Number of ADA-positive participants.
Time frame: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories | Overall Incidence, n2/N1 | 1 Participants |
Secondary
Number of Participants by Antidrug Antibody (ADA) Categories
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted).
Time frame: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 3 Participants |
| PF-07209960 1 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 1 Participants |
| PF-07209960 1 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 4 Participants |
| PF-07209960 3 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 3 Participants |
| PF-07209960 3 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 3 Participants |
| PF-07209960 10 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 1 Participants |
| PF-07209960 10 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 3 Participants |
| PF-07209960 10 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 3 Participants |
| PF-07209960 10 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 4 Participants |
| PF-07209960 15 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 3 Participants |
| PF-07209960 15 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 8 Participants |
| PF-07209960 20 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 6 Participants |
| PF-07209960 20 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 5 Participants |
| PF-07209960 20 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 13 Participants |
| PF-07209960 30 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Evaluable participants with pre-existing antibody, n/N1 | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-induced | 4 Participants |
| PF-07209960 30 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Baseline-positive participants with non-boosted antibody response, n1/N1 | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Treatment-boosted | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants by Antidrug Antibody (ADA) Categories | Overall Incidence, n2/N1 | 5 Participants |
Secondary
Number of Participants by Anti-IL-15 Wild Type NAb Categories
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (NAb) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced).
Time frame: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment NAb result (N1).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07209960 1 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 1 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 3 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 3 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 2 Participants |
| PF-07209960 10 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 10 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 15 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 15 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 20 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 20 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 1 Participants |
| PF-07209960 30 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Evaluable participants with pre-existing antibody, n/N1 | 0 Participants |
| PF-07209960 30 mg SC | Number of Participants by Anti-IL-15 Wild Type NAb Categories | Overall Incidence, n2/N1 | 2 Participants |
Secondary
Percentage of Participants With Disease Control Based on Investigator Assessment
Disease control rate (DCR) is defined as the percentage of participants with a BOR of CR, PR, non-CR/non-PD or SD.
Time frame: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately)
Population: Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07209960 1 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 66.7 Percentage of Participants |
| PF-07209960 3 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 75.0 Percentage of Participants |
| PF-07209960 10 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 66.7 Percentage of Participants |
| PF-07209960 15 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 0 Percentage of Participants |
| PF-07209960 20 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 45.5 Percentage of Participants |
| PF-07209960 30 mg SC | Percentage of Participants With Disease Control Based on Investigator Assessment | 40.0 Percentage of Participants |
Secondary
Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis \<10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
Time frame: From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months)
Population: Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07209960 1 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 0 Percentage of participants |
| PF-07209960 3 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 0 Percentage of participants |
| PF-07209960 10 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 0 Percentage of participants |
| PF-07209960 15 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 0 Percentage of participants |
| PF-07209960 20 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 9.1 Percentage of participants |
| PF-07209960 30 mg SC | Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 20.0 Percentage of participants |
Secondary
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants
PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause, or censoring, whichever occurred first. Both new anti-cancer therapy given prior to PD or death and no PD by the end of follow-up are censoring events.
Time frame: Baseline through up to 2 years or until disease progression
Population: The full analysis set includes all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07209960 1 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 2.8 Months |
| PF-07209960 3 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 2.8 Months |
| PF-07209960 10 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 3.8 Months |
| PF-07209960 15 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 1.6 Months |
| PF-07209960 20 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 1.8 Months |
| PF-07209960 30 mg SC | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants | 2.0 Months |
Secondary
Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment
TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events
Time frame: Baseline through up to 2 years or until disease progression
Population: The full analysis set included all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07209960 1 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 3.7 Months |
| PF-07209960 3 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 2.8 Months |
| PF-07209960 10 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 3.8 Months |
| PF-07209960 15 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 1.6 Months |
| PF-07209960 20 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 1.8 Months |
| PF-07209960 30 mg SC | Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment | 2.0 Months |