Merck & Co. announced Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for use in the first-line treatment of certain patients with metastatic non-squamous non-small-cell lung cancer (NSCLC). Specifically, Merck is seeking to expand its anti-PD-1 therapy for use in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy in adults who do not carry EGFR or ALK mutations, regardless of their PD-L1 expression.
The submission for this indication was backed by data from the late-stage KEYNOTE-189 study of 614 patients with advanced or metastatic non-squamous NSCLC. In the study, whose results were unveiled in January, Keytruda in combination with Alimta and cisplatin or carboplatin was found to significantly prolong progression-free and overall survival (OS) versus Alimta and cisplatin or carboplatin alone.
Roger Perlmutter, president of Merck Research Laboratories, remarked "there is significant need for innovative therapies that can improve the overall survival of patients suffering from metastatic [NSCLC], as lung cancer is the leading cause of cancer deaths in Europe."
FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Meanwhile, the CHMP also recommended that Keytruda be approved as monotherapy to treat recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a tumour proportion score of at least 50 percent, and who progressed on or after exposure to platinum-based chemotherapy. Merck explained that its filing was supported by data from the Phase III KEYNOTE-040 study, although the company previously reported that the therapy had failed to meet its primary endpoint of OS in the trial. However, Merck released data from an interim analysis of the Phase III KEYNOTE-048 trial last week showing that Keytruda monotherapy significantly improved OS when used as a first-line treatment among HNSCC patients whose tumours expressed PD-L1.
FirstWord reports in this therapy area - KOL Insight Head and Neck Squamous Cell Carcinoma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Final decisions regarding EU approval for both indications are anticipated in the third quarter, Merck said. Keytruda has been cleared for several indications in Europe, including PD-L1-positive NSCLC and first-line treatment of certain patients with metastatic NSCLC whose tumours have high PD-L1 expression.
For related analysis on the therapy, see ViewPoints: Keytruda rivals may be fighting for lucrative scraps in NSCLC. See also ViewPoints: Keytruda's bounce-back in HNSCC is a blow to Erbitux.
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