Metastatic Nonsquamous Non-Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Cancer
Conditions
Keywords
Metastatic, non-small cell lung cancer, nonsquamous, squamous, PD-1, PD-L1
Brief summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Interventions
DRUGRetifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
DRUGPlacebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
DRUGPemetrexed
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
DRUGCisplatin
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
DRUGCarboplatin
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
DRUGPaclitaxel
Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
DRUGnab-Paclitaxel
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8). * No prior systemic treatment for the advanced/metastatic NSCLC * Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 3 months. * Willingness to avoid pregnancy or fathering children. * Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.
Exclusion criteria
* Clinically significant cardiac disease within 6 months of start of study treatment. * Any major surgery within 3 weeks of the first dose of study treatment. * Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment. * History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel. * Untreated central nervous system metastases and/or carcinomatous meningitis. * Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids. * Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained. * Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers. * Has contraindications to chemotherapy agents used in the study. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment. * Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug). Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained. • Has known active HBV or HCV (testing must be performed to determine eligibility)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 39.1 months | Overall survival was defined as the time between the date of randomization and the date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | up to 35.8 months | PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression. |
| Objective Response Rate | up to 35.78 months | Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
| Duration of Response | up to 34.3 months | Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period | up to approximately 39 months | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. |
| Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period | up to approximately 39 months | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. |
| Number of Participants With Any TEAE in the Monotherapy Treatment Period | up to approximately 27 months | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. |
| Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period | up to approximately 27 months | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. |
| Cmax1 of Retifanlimab When Administered With Chemotherapy | Cycle 1 Day 1: pre-infusion and immediately after infusion | Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab. |
| AUC1 of Retifanlimab When Administered With Chemotherapy | Cycle 1 Day 1: pre-infusion and immediately after infusion | AUC1 was defined as the first-dose area under the serum concentration versus time curve. |
| Cmaxss of Retifanlimab When Administered With Chemotherapy | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. | Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state. |
| AUCss of Retifanlimab When Administered With Chemotherapy | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. | AUCss was defined as the area under the serum concentration versus time curve at steady state. |
Countries
Brazil, Bulgaria, China, Czechia, Georgia, Hungary, Malaysia, Philippines, Poland, Romania, Russia, Serbia, South Africa, Turkey (Türkiye), Ukraine, United States, Vietnam
Contacts
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Participant flow
Pre-assignment details
This study was conducted in Bulgaria, Brazil, China, Czech Republic, Georgia, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Turkey, Ukraine, United States, Vietnam, and South Africa. Data collected through 15 December 2023 have been included in this results summary.
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Chemotherapy Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \[D1\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\^2) + either cisplatin 75 mg/m\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\^2 (on D1) or nab-paclitaxel 100 mg/m\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. Participants who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \[21-day cycles\]) in the optional monotherapy treatment period. | 192 |
| Retifanlimab + Chemotherapy Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\^2 + either cisplatin 75 mg/m\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\^2 (on D1) or nab-paclitaxel 100 mg/m\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. | 391 |
| Total | 583 |
Baseline characteristics
| Characteristic | Placebo + Chemotherapy | Retifanlimab + Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 8.34 | 62.8 years STANDARD_DEVIATION 8.44 | 62.8 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 15 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants | 375 Participants | 559 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 62 Participants | 127 Participants | 189 Participants |
| Race/Ethnicity, Customized Black/African-American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/White biracial | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 127 Participants | 260 Participants | 387 Participants |
| Sex: Female, Male Female | 43 Participants | 73 Participants | 116 Participants |
| Sex: Female, Male Male | 149 Participants | 318 Participants | 467 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 234 / 391 | 140 / 192 | 374 / 583 | 42 / 59 |
| other Total, other adverse events | 350 / 389 | 177 / 190 | 527 / 579 | 44 / 59 |
| serious Total, serious adverse events | 158 / 389 | 57 / 190 | 215 / 579 | 12 / 59 |
Outcome results
Primary
Overall Survival
Overall survival was defined as the time between the date of randomization and the date of death due to any cause.
Time frame: up to 39.1 months
Population: Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. Full Analysis Set: all participants to whom study treatment had been assigned by randomization. Participants were analyzed according to the treatment and strata they had been assigned to during the randomization procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo + Chemotherapy | Overall Survival | 13.4 months |
| Retifanlimab + Chemotherapy | Overall Survival | 18.1 months |
p-value: 0.004295% CI: [0.6, 0.93]Log Rank
Secondary
AUC1 of Retifanlimab When Administered With Chemotherapy
AUC1 was defined as the first-dose area under the serum concentration versus time curve.
Time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion
Population: PK Evaluable Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab + Chemotherapy | AUC1 of Retifanlimab When Administered With Chemotherapy | 775 mg/L x day | Geometric Coefficient of Variation 25 |
Secondary
AUCss of Retifanlimab When Administered With Chemotherapy
AUCss was defined as the area under the serum concentration versus time curve at steady state.
Time frame: Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.
Population: PK Evaluable Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab + Chemotherapy | AUCss of Retifanlimab When Administered With Chemotherapy | 791 mg/L x day | Geometric Coefficient of Variation 23.1 |
Secondary
Cmax1 of Retifanlimab When Administered With Chemotherapy
Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.
Time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion
Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of retifanlimab and provided at least 1 PK post-dose sample
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab + Chemotherapy | Cmax1 of Retifanlimab When Administered With Chemotherapy | 109 milligrams per liter (mg/L) | Geometric Coefficient of Variation 23.1 |
Secondary
Cmaxss of Retifanlimab When Administered With Chemotherapy
Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.
Time frame: Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.
Population: PK Evaluable Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab + Chemotherapy | Cmaxss of Retifanlimab When Administered With Chemotherapy | 109 mg/L | Geometric Coefficient of Variation 23.1 |
Secondary
Duration of Response
Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Time frame: up to 34.3 months
Population: Full Analysis Set. Only those participants with a confirmed response were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo + Chemotherapy | Duration of Response | 6.1 months |
| Retifanlimab + Chemotherapy | Duration of Response | 12.7 months |
Secondary
Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.
Time frame: up to approximately 27 months
Population: Monotherapy Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo + Chemotherapy | Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period | 4 Participants |
Secondary
Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.
Time frame: up to approximately 39 months
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo + Chemotherapy | Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period | 9 Participants |
| Retifanlimab + Chemotherapy | Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period | 33 Participants |
Secondary
Number of Participants With Any TEAE in the Monotherapy Treatment Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.
Time frame: up to approximately 27 months
Population: Monotherapy Analysis Set: all participants who were randomized to the placebo group and received at least 1 dose of placebo, who then transitioned and received at least 1 dose of retifanlimab
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo + Chemotherapy | Number of Participants With Any TEAE in the Monotherapy Treatment Period | 50 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.
Time frame: up to approximately 39 months
Population: Safety Population: all participants who received at least 1 dose of study treatment. Treatment groups for this population were determined by the actual treatment that the participant received regardless of treatment assignment at randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo + Chemotherapy | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period | 183 Participants |
| Retifanlimab + Chemotherapy | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period | 369 Participants |
Secondary
Objective Response Rate
Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Time frame: up to 35.78 months
Population: Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Chemotherapy | Objective Response Rate | 38.5 percentage of participants |
| Retifanlimab + Chemotherapy | Objective Response Rate | 51.7 percentage of participants |
p-value: 0.0012Cochran-Mantel-Haenszel
Secondary
Progression-free Survival (PFS)
PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression.
Time frame: up to 35.8 months
Population: Full Analysis Set. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo + Chemotherapy | Progression-free Survival (PFS) | 5.5 months |
| Retifanlimab + Chemotherapy | Progression-free Survival (PFS) | 7.7 months |
p-value: <0.000195% CI: [0.52, 0.79]Log Rank