New Indication: Adjuvant Pembrolizumab in NSCLC
Study
Randomised, triple-blind, phase 3 trial
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Stage IB (tumours of ≥4 cm in diameter), II, or IIIA NSCLC
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Pembrolizumab 200 mg (590) or placebo (587) / 3 weeks-18 cycles
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Efficacy
mDFS: 53.6 m vs 42.0 m (HR 0.76 [95% CI 0.63–0.91], p=0.0014)
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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).
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3 year OS: 82% vs %80
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Safety
Any grade AEs: 96% vs 91%
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Grade ≥3 AEs: 34.7% vs 26.8%
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Discontination due to adverse events: 20% vs 6%
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Death due to adverse events: 2% vs 1%
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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
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022