The Food and Drug Administration (FDA) has granted full approval to Keytruda (pembrolizumab; Merck) in combination with pemetrexed and platinum chemotherapy, as a first-line treatment for patients with metastatic, nonsquamous non-small cell lung cancer (NSqNSCLC) with no EGFR or ALK genomic tumor aberrations. This approval follows the fulfillment of a postmarketing commitment demonstrating the treatment’s clinical benefit.
The full approval for this indication was based on data from the KEYNOTE-189 study (NCT02578680), which enrolled 616 individuals with NSqNSCLC. Patients were randomized (2:1) to receive Keytruda or placebo in combination with pemetrexed, and either cisplatin or carboplatin every 3 weeks for 4 cycles followed by Keytruda or placebo and pemetrexed.
Results showed a statistically significant improvement in overall survival (OS) for those treated with Keytruda and chemotherapy (HR 0.49; 95% CI: 0.38, 0.64; P<.00001). The median OS was not reached at the time of the data cut-off in the Keytruda plus chemotherapy arm and was 11.3 months for those in the chemotherapy arm.
Progression Free Survival (PFS) was also improved in the Keytruda plus chemotherapy group (HR 0.52; 95% CI: 0.43, 0.6; P<.00001). The median PFS was 8.8 months for patients receiving Keytruda plus chemotherapy and 4.9 months for those receiving chemotherapy alone. The secondary outcome of overall response rate was 48% vs 19% for the treatment vs placebo; complete response was 0.5% for both groups (P<.0001).
Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and PFS for patients randomized to Keytruda + pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.
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