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KEYNOTE-021 cohort G

Carboplatin and pemetrexed with or without pembrolizumab for advanced non-squamous non-small-cell lung cancer: randomised phase 2 cohort of KEYNOTE-021

Phase 2N = 123NCT02039674

Population
Chemotherapy-naive stage IIIB or IV non-squamous NSCLC without targetable EGFR or ALK genetic aberrations
Design
Randomised (1:1), open-label phase 2 cohort of a multicohort study. Four cycles of pembrolizumab 200 mg plus carboplatin and pemetrexed every 3 weeks, then pembrolizumab for 24 months and pemetrexed maintenance, versus four cycles of carboplatin and pemetrexed then pemetrexed maintenance.
Primary endpoint
ORR
Arms
  • Pembrolizumab plus carboplatin and pemetrexed (experimental, n = 60): Pembrolizumab 200 mg, carboplatin and pemetrexed for 4 cycles, then pembrolizumab for 24 months and pemetrexed maintenance
  • Carboplatin and pemetrexed (control, n = 63): Carboplatin and pemetrexed for 4 cycles, then pemetrexed maintenance
People
Langer CJ, KEYNOTE-021 investigators
Δ ORR+26 points
Show the numbers
Results reported for KEYNOTE-021 cohort G
EndpointAnalysisPembrolizumab plus carboplatin and pemetrexedCarboplatin and pemetrexedEffect
ORRRadiologically confirmed complete or partial response per RECIST v1.1, masked independent central reviewprimaryLanger 201655% (42–68%)29% (18–41%)P=0.0016Estimated treatment difference 26% (95% CI 9 to 42%). Grade 3 or worse treatment-related adverse events: 39% vs 26%. The design used a one-sided significance threshold of p<0.025 (stated in the abstract and the open-access full text).
Results reported for KEYNOTE-021 cohort G
EndpointAnalysisPembrolizumab plus carboplatin and pemetrexedCarboplatin and pemetrexedEffect
ORRRadiologically confirmed complete or partial response per RECIST v1.1, masked independent central reviewprimaryLanger 201655% (42–68%)29% (18–41%)P=0.0016Estimated treatment difference 26% (95% CI 9 to 42%). Grade 3 or worse treatment-related adverse events: 39% vs 26%. The design used a one-sided significance threshold of p<0.025 (stated in the abstract and the open-access full text).
Primary publication: Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497-1508. PubMedDOI

Appears in

Sources

  1. Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497-1508.

    PubMedDOI