Non-small Cell Lung Cancer
Conditions
Keywords
PD1, PD-1, PDL1, PD-L1
Brief summary
This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).
Interventions
BIOLOGICALPembrolizumab
Intravenous infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review * At least one measurable lesion * Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease * Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 * Adequate organ function
Exclusion criteria
* Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment * Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication * Expected to require any other form of systemic or localized antineoplastic therapy while on trial * History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer * Active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody * Concurrent or past history of interstitial lung disease * Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants | Up to 2 years | On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented. |
| Number of Participants Experiencing Adverse Events (AEs) | Up to 27 months (Up to 90 days after last dose of study drug) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug). The number of participants who experienced an AE is presented. |
| Number of Participants Discontinuing Study Drug Due to AEs | Up to 2 years | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants | Up to 2 years | ORR per irRC was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: Complete disappearance of all tumor lesions \[whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented\]) or Partial Response (irPR: Decrease in sum of the products of the two largest perpendicular diameters \[SPD\] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of strongly PD-L1 positive participants who experienced an irCR or irPR is presented. |
| PFS Per irRC in Strongly PD-L1 Positive Participants | Up to 2 years | PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all strongly PD-L1 positive participants. |
| DOR Per irRC in Strongly PD-L1 Positive Participants | Up to 2 years | DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all strongly PD-L1 positive participants who experienced an irCR or irPR. |
| ORR Per RECIST 1.1 in PD-L1 Positive Participants | Up to 2 years | On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of PD-L1 positive participants who experienced a CR or PR is presented. |
| PFS by RECIST 1.1 in PD-L1 Positive Participants | Up to 2 years | PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all PD-L1 positive participants is presented. |
| Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants | Up to 2 years | PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all strongly PD-L1 positive participants is presented. |
| OS in PD-L1 Positive Participants | Up to 2 years | OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all PD-L1 positive participants in months. |
| ORR Per irRC in PD-L1 Positive Participants | Up to 2 years | ORR per irRC was defined as the percentage of participants in the analysis population who had a irCR (Complete disappearance of all tumor lesions \[whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented\]) or irPR (Decrease in sum of the products of the two largest perpendicular diameters \[SPD\] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of PD-L1 positive participants who experienced an irCR or irPR is presented. |
| PFS Per irRC in PD-L1 Positive Participants | Up to 2 years | PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all PD-L1 positive participants. |
| DOR Per irRC in PD-L1 Positive Participants | Up to 2 years | DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all PD-L1 positive participants who experienced an irCR or irPR. |
| DOR by RECIST 1.1 in PD-L1 Positive Participants | Up to 2 years | DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all PD-L1 positive participants with a confirmed response is presented. |
| Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants | Up to 2 years | DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all strongly PD-L1 positive participants with a confirmed response is presented. |
| Overall Survival (OS) in Strongly PD-L1 Positive Participants | Up to 2 years | OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all strongly PD-L1 positive participants in months |
Participant flow
Recruitment details
Participants with non-small cell lung cancer (NSCLC) who were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.
Pre-assignment details
Thirty-eight (38) participants were enrolled in this study. The data cut-off date for this results disclosure was 30 July 2017.
Participants by arm
| Arm | Count |
|---|---|
| Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Clinical Progression | 4 |
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Progressive Disease | 21 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Pembrolizumab 10 mg/kg |
|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 8.5 |
| Programmed Cell Death Ligand 1 (PD-L1) Expression Status Strongly Positive PD-L1 | 12 Participants |
| Programmed Cell Death Ligand 1 (PD-L1) Expression Status Weakly Positive PD-L1 | 26 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 38 |
| other Total, other adverse events | 38 / 38 |
| serious Total, serious adverse events | 14 / 38 |
Outcome results
Primary
Number of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.
Time frame: Up to 2 years
Population: The ATS population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Number of Participants Discontinuing Study Drug Due to AEs | 4 Participants |
Primary
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug). The number of participants who experienced an AE is presented.
Time frame: Up to 27 months (Up to 90 days after last dose of study drug)
Population: The All Treated Set (ATS) population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Number of Participants Experiencing Adverse Events (AEs) | 38 Participants |
Primary
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants
On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
Time frame: Up to 2 years
Population: The Full Analysis Set (FAS) population consisted of all participants who were classified as strongly PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants | 27.3 Percentage of Participants |
Secondary
DOR by RECIST 1.1 in PD-L1 Positive Participants
DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all PD-L1 positive participants with a confirmed response is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | DOR by RECIST 1.1 in PD-L1 Positive Participants | 694.0 Days |
Secondary
DOR Per irRC in PD-L1 Positive Participants
DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all PD-L1 positive participants who experienced an irCR or irPR.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | DOR Per irRC in PD-L1 Positive Participants | 757.0 Days |
Secondary
DOR Per irRC in Strongly PD-L1 Positive Participants
DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all strongly PD-L1 positive participants who experienced an irCR or irPR.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | DOR Per irRC in Strongly PD-L1 Positive Participants | 503.0 Days |
Secondary
Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants
DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all strongly PD-L1 positive participants with a confirmed response is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants | NA Days |
Secondary
ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants
ORR per irRC was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: Complete disappearance of all tumor lesions \[whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented\]) or Partial Response (irPR: Decrease in sum of the products of the two largest perpendicular diameters \[SPD\] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of strongly PD-L1 positive participants who experienced an irCR or irPR is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab 10 mg/kg | ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants | 25.0 Percentage of Participants |
Secondary
ORR Per irRC in PD-L1 Positive Participants
ORR per irRC was defined as the percentage of participants in the analysis population who had a irCR (Complete disappearance of all tumor lesions \[whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented\]) or irPR (Decrease in sum of the products of the two largest perpendicular diameters \[SPD\] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of PD-L1 positive participants who experienced an irCR or irPR is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab 10 mg/kg | ORR Per irRC in PD-L1 Positive Participants | 21.1 Percentage of Participants |
Secondary
ORR Per RECIST 1.1 in PD-L1 Positive Participants
On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of PD-L1 positive participants who experienced a CR or PR is presented.
Time frame: Up to 2 years
Population: The FAS population for this outcome measure consisted of all participants who were classified as PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab 10 mg/kg | ORR Per RECIST 1.1 in PD-L1 Positive Participants | 21.6 Percentage of Participants |
Secondary
OS in PD-L1 Positive Participants
OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all PD-L1 positive participants in months.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | OS in PD-L1 Positive Participants | 19.2 Months |
Secondary
Overall Survival (OS) in Strongly PD-L1 Positive Participants
OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all strongly PD-L1 positive participants in months
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Overall Survival (OS) in Strongly PD-L1 Positive Participants | 17.9 Months |
Secondary
PFS by RECIST 1.1 in PD-L1 Positive Participants
PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all PD-L1 positive participants is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | PFS by RECIST 1.1 in PD-L1 Positive Participants | 3.9 Months |
Secondary
PFS Per irRC in PD-L1 Positive Participants
PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all PD-L1 positive participants.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | PFS Per irRC in PD-L1 Positive Participants | 4.2 Months |
Secondary
PFS Per irRC in Strongly PD-L1 Positive Participants
PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all strongly PD-L1 positive participants.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | PFS Per irRC in Strongly PD-L1 Positive Participants | 5.2 Months |
Secondary
Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants
PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all strongly PD-L1 positive participants is presented.
Time frame: Up to 2 years
Population: The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab 10 mg/kg | Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants | 4.1 Months |