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New Protocol – Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial

New Protocol – Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial
Study:
  • Randomised, triple-blind, phase 3 trial
  • Stage IB (tumours of ≥4 cm in diameter), II, or IIIA NSCLC
  • Pembrolizumab 200 mg (590) or placebo (587) / 3 weeks-18 cycles
Efficacy:
  • mDFS: 53.6 m vs 42.0 m (HR 0.76 [95% CI 0.63–0.91], p=0.0014)
  • mDFS: NR vs NR in the PD-L1 TPS of 50% or greater population (HR 0.82 [95% CI 0.57–1.18]; p=014).
  • 3 year OS: 82% vs %80
Safety:
  • Any grade AEs: 96% vs 91%
  • Grade ≥3 AEs: 34.7% vs 26.8%
  • Discontination due to adverse events: 20% vs 6%
  • Death due to adverse events: 2% vs 1%

Lancet Oncol. 2022 Sep 9;S1470-2045(22)00518-6.

O’Brien M, Paz-Ares L, Marreaud S, et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial

https://doi.org/10.1016/s1470-2045(22)00518-6

Reviewed by Hasan Çağrı Yıldırım, MD on Sep 28, 2022

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