Pembrolizumab (Keytruda) was granted accelerated approval by the FDA in combination with pemetrexed and carboplatin to treat patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).
The approval was based on findings from the multicenter, multi-cohort KEYNOTE-021 study, which included 123 treatment-naive patients with locally advanced or metastatic non-squamous NSCLC.
Participants were randomized to receive either 200 mg of pembrolizumab every 3 weeks combined with pemetrexed and carboplatin (PC) for 4 cycles followed by pembrolizumab for a maximum of 24 months, compared with PC alone.
At the investigators’ discretion, patients in both groups could receive pemetrexed as maintenance therapy, according to a press release.
The results of the study showed an improvement in overall response rate (ORR) and in progression-free survival (PFS) for patients administered pembrolizumab plus PC. The ORR was 55% in the pembrolizumab plus PC arm and 29% for the PC alone arm. –
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