Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for use in combination with pemetrexed (Alimta) and carboplatin as first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. 

The FDA’s accelerated approval was based on tumor response rate and progression-free survival (PFS) from the KEYNOTE-021 study, Cohort G1 (n=123), that included previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations and irrespective of PD-L1 expression.

In the study, Keytruda + pemetrexed/carboplatin showed an objective response rate (ORR) that was almost twice that of pemetrexed/carboplatin alone (55% [95% CI: 42, 68] vs. 29% [95% CI: 18, 41]). In the Keytruda + pemetrexed/carboplatin treatment group, 93% showed a duration of response ≥6 months vs. 91% in the pemetrexed/carboplatin treatment group.  Also, there was an improvement in PFS (hazard ratio [HR] 0.53 [95% CI: 0.31-0.91]; P=0.0205) with a median PFS of 13 months (95% CI: 8.3-not estimable) for patients who received Keytruda + pemetrexed/carboplatin vs. 8.9 months (95% CI: 4.4-10.3) who received pemetrexed/carboplatin alone.  

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The approval marks Keytruda as the only anti-PD-1 agent approved in the first-line setting as both monotherapy and combination therapy for appropriate patients with metastatic NSCLC. 

Keytruda monotherapy is approved as first-line for patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Keytruda monotherapy can also be used as second-line or greater treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.

Keytruda is available as a 50mg/vial lyophilized powder for IV infusion after reconstitution and as a 25mg/mL solution for IV infusion after dilution.

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