Is Pembrolizumab Effective for Lung Cancer?

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

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

Figure 1

Figure 2

Figure 3

Figure 4

Related Cancer Information

• Lung cancer