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.

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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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This article originally appeared on MPR