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FDA Approves Keytruda Combination for Non-Small Cell Lung Cancer Subset


The immunotherapy agent received approval for the treatment of metastatic squamous non-small cell lung cancer.

The Food and Drug Administration (FDA) approved the combination use of Keytruda (pembrolizumab) plus carboplatin and either paclitaxel or nab-paclitacel to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) — a disease that accounts for 20 to 30 percent of all lung cancers – according to Merck, the manufacturer of the immunotherapy agent.

The agency based its approval on results from the phase 3 KEYNOTE-407 trial, which was recently presented at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer. The trial randomized 559 patients to receive either 200 mg of Keytruda (278 patients) or placebo (281 patients) on the first day of 35 cycles. For the first four cycles, all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]—paclitaxel. Patients were followed for a median of 7.8 months.

The Keytruda regimen prolonged median overall survival by 4.6 months (15.9 months vs. 11.3 months) and median progression-free survival by 1.6 months (6.4 months vs. 4.8 months). Keytruda’s survival benefit was consistent, regardless of PD-L1 expression among patients treated with the agent.

In addition, the Keytruda regimen demonstrated superior response rates (57.9 percent vs. 38.4 percent) compared with placebo, reducing the risk of disease progression or death by 44 percent.

Grade 3 or higher side effects occurred in 69.8 percent of patients treated with Keytruda, including neutropenia (22.7 percent), anemia (15.5 percent), thrombocytopenia (6.8 percent) and diahrrea (4 percent).

This is Keytruda’s fifth approval in the lung cancer space. The drug is also approved to treat certain types of melanoma, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) solid tumors, gastric cancer and cervical cancer.

“Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “Approval by the FDA has the potential to mean that KEYTRUDA can be used to improve survival for more patients with this debilitating disease.”

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