FDA OKs Keytruda with Chemotherapy for Squamous NSCLC

Officials with the FDA have approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), according to a press release.

The expanded indication marks the first time an anti-PD-1 regimen has been approved in the first-line setting as both combination and monotherapy for squamous NSCLC, regardless of tumor PD-L1 expression status.

Pembrolizumab was previously granted approval in August for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

The latest approval is based on the phase 3 KEYNOTE-407 trial, which showed a significant improvement in overall survival in patients with metastatic squamous NSCLC, regardless of tumor PD-L1 expression status, and no prior systemic treatment for metastatic disease.

For the trial, 1 group of patients received pembrolizumab 200 mg plus carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8, and 15 of every 3-week cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks. The other group received a placebo and carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8, and 15 of every 3-week cycle for 4 cycles, followed by placebo every 3 weeks.

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