Pemetrexed maintenance with or without pembrolizumab in non-squamous non-small cell lung cancer: A cross-trial comparison of KEYNOTE-189 versus PARAMOUNT, PRONOUNCE, and JVBL

ObjectiveTo characterize the benefit-risk profile of pemetrexed and platinum in combination with pembrolizumab patients non-squamous non-small cell lung cancer KEYNOTE-189 study, reference to historical maintenance data from PARAMOUNT, PRONOUNCE, JVBL randomized studies.Materials methodsTo harmonize treatment setting across studies our comparative analysis, we selected who received ≥5 cycles (pembrolizumab/pemetrexed/platinum, N = 310; placebo/pemetrexed/platinum, 135) pooled PARAMOUNT (N 359), PRONOUNCE 98), 29) (total, 486). For 2 populations data, progression-free survival (PFS) was evaluated by Kaplan-Meier estimator Cox proportional hazards model. Tumor response grade ≥3 treatment-emergent adverse events (TEAEs) for aforementioned population were summarized descriptive statistics.ResultsIn pemetrexed, median PFS 9.3 months (95 % confidence interval [CI]: 9.0–11.1) pembrolizumab/pemetrexed/platinum arm 6.6 CI: 5.4–7.1) placebo/pemetrexed/platinum (unstratified hazard ratio: 0.53; 95 0.42‒0.68; p ≤ 0.0001). In trials, 5.6 4.6–5.8). Objective rates 58.7 28.9 arms, respectively, 42.4 studies. The incidence TEAEs similar both arms studies.ConclusionImproved shown compared patient group (≥5 cycles) KEYNOTE-189. safety control comparable data.