FDA Grants Lung Cancer Combination Accelerated Approval

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.

Ninety-three percent of patients who had a response that lasted 6 months or longer in the pembrolizumab arm and 81% in the PC alone arm, according to the release. The HR for PFS was 0.53 and the median PFS was 13 months in the pembrolizumab plus PC arm compared with 8.9 months in the PC alone arm.

Analyses of ORR were conducted in subgroups of patients with PD-L1 tumor expression, according to the release. The ORR was 57% in the pembrolizumab plus PC arm and 13% in the PC alone arm.

The most common adverse events (AEs) that were all grades in the pembrolizumab plus PC group was fatigue, nausea, and constipation. The most common grade 3 and 4 AEs were fatigue, dyspnea, nausea, vomiting, diarrhea, and rash.

The treatment was discontinued in 10% of patients due to AEs, with the most common being acute kidney injury.