Is Pembrolizumab Effective for Lung Cancer?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On September 11, 2022, Mary O’Brien and colleagues from Royal Marsden Hospital published the results of the Phase 3 PEARLS/KEYNOTE-091 clinical trial in "The Lancet Oncology." The study evaluated the efficacy and safety of adjuvant Pembrolizumab in patients with completely resected Stage IB–IIIA non-small cell lung cancer (NSCLC).
PEARLS/KEYNOTE-091 is a multi-center, randomized Phase 3 trial. Patients with completely resected Stage IB–IIIA NSCLC (N=1177) were randomized 1:1 to receive either Pembrolizumab (200 mg every 3 weeks for up to 18 cycles, N=590; 168 with TPS ≥ 50%) or placebo (N=587; 165 with TPS ≥ 50%). The primary endpoints were disease-free survival (DFS) in the overall population and in the PD-L1 positive population. The secondary endpoint was overall survival (OS).
With a median follow-up of 35.6 months, the median DFS in the overall population was 53.6 months in the Pembrolizumab group compared to 42.0 months in the placebo group. For the PD-L1 positive population, the median DFS was not reached in either group.
Regarding safety, the incidence of Grade 3 or higher adverse events was 34% (N=198) in the Pembrolizumab group and 26% (N=150) in the placebo group. The most common Grade 3 or higher adverse events confirmed in at least 10 patients were hypertension (Pembrolizumab: 6% [N=35], Placebo: 6% [N=32]) and pneumonia (Pembrolizumab: 2% [N=12]).
Serious adverse events occurred in 24% (N=142) of the Pembrolizumab group and 15% (N=90) of the placebo group. Serious adverse events occurring in at least 1% of patients in the Pembrolizumab group included pneumonia (2% [N=13]), pneumonitis (2% [N=12]), and diarrhea (1% [N=7]). In the Pembrolizumab group, 4 deaths were attributed to treatment-related adverse events: cardiogenic shock and myocarditis (1), septic shock and myocarditis (1), pneumonia (1), and sudden death (1).
Based on the PEARLS/KEYNOTE-091 results, Mary O’Brien stated that adjuvant Pembrolizumab significantly improved disease-free survival in patients with completely resected Stage IB–IIIA NSCLC and represents a potential new treatment option for this population.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00518-6/fulltext#%20
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