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FDA approves Keytruda as part of first-line combination for metastatic nonsquamous NSCLC
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The FDA approved pembrolizumab for use in combination with pemetrexed and carboplatin as first-line treatment of metastatic nonsquamous non–small cell lung cancer, according to the drug’s manufacturer.
The approval allows use of pembrolizumab (Keytruda, Merck) regardless of patients’ PD-L1 expression.
The FDA based its approval on results from a cohort in the KEYNOTE-021 trial.
The open-label, multicenter, multi-cohort trial compared first-line pembrolizumab plus pemetrexed (Alimta, Eli Lilly) and carboplatin with pemetrexed and carboplatin alone in 123 treatment-naive patients with metastatic nonsquamous NSCLC. The patients had no EGFR or ALK genomic tumor aberrations, and they received treatment irrespective of PD-L1 expression.
Sixty patients received 200 mg pembrolizumab, 500 mg/m2 pemetrexed and carboplatin area under the curve 5 mg/mL/min every 3 weeks for four cycles, followed by pembrolizumab every 3 weeks. The other 63 patients received the pemetrexed/carboplatin regimen alone.
The pembrolizumab regimen extended median PFS (13 months vs. 8.9 months; HR = 0.53; 0.31-0.91) and improved objective response rate (55% vs. 29%). All responses were partial responses. More patients assigned the pembrolizumab regimen achieved a response of at least 6 months (93% vs. 81%).
“The improved responses seen with the [pembrolizumab] plus pemetrexed/carboplatin regimen are significant, and highlight the importance of finding new approaches that address the unmet needs of patients with metastatic nonsquamous NSCLC,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a company-issued press release.
The most common adverse reactions among pembrolizumab-treated patients included fatigue (8%), neutrophil count decreased (8%), anemia (5%), dyspnea (3.4%) and pneumonitis (3.4%).
“This approval marks an important milestone in the treatment of lung cancer,” Corey Langer, MD, director of thoracic oncology and professor of medicine at Hospital of the University of Pennsylvania, said in the release. “Now, pembrolizumab in combination with pemetrexed and carboplatin can be prescribed in the first-line setting for patients with metastatic nonsquamous non-small cell lung cancer, irrespective of PD-L1 expression. Physicians should continue to use each patient’s individual characteristics – including biomarker status, histology, and other clinical factors – to determine the best treatment plan for each person.”
The FDA previously approved pembrolizumab for several other indications related to the treatment of patients with metastatic NSCLC, unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma, or refractory classical Hodgkin lymphoma.