The FDA has granted priority review for Merck’s Keytruda (pembrolizumab) + Alimta (pemetrexed injection) + platinum-based chemotherapy combination as a first-line treatment for patients with metastatic non-squamous, non-small cell lung cancer (NSCLC).

The submission of Merck’s supplemental Biologics License Application (sBLA) was announced on Monday, April 30, and the FDA has set a Prescription Drug User Fee Act (PDUFA) date of September 23, 2018. This anti-programed cell death protein 1 (anti-PD-1) + chemotherapy combination is expected to have a significant impact on the NSCLC space, and may be a promising strategy for other solid tumors, such as head and neck squamous-cell carcinoma (HNSCC).

The FDA accepted the sBLA application based on the overall survival (OS) data and progression-free survival (PFS) data released from the Phase III KEYNOTE-189 study.  This double-blind, Phase III study involved 616 patients with NSCLC without ALK or EGFR mutations who had no previous treatment, regardless of programmed death-ligand 1 (PD-L1) expression. The combination reduced the risk of death by over 50%. Based on this dataset, the European Medicines Agency (EMA) has also begun the review process for Merck’s application.

Based on the GlobalData’s analysis, approximately 17,000 first-line (1L) non-squamous NSCLC patients are expected to receive this combination in 2025 in the US. Merck is also evaluating Keytruda in combination with platinum-based chemotherapy + fluorouracil (5-FU) for recurrent/metastatic (rm)HNSCC in the Phase III KEYNOTE-048 trial, which is expected to release data in H1 2019. This combination could extend the use of Keytruda into the 1L rmHNSCC setting for the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan).

Overall, Merck’s Keytruda is in a strong position to gain robust uptake in the NSCLC and HNSCC market with its anti-PD-1 + chemotherapy combination strategy, regardless of patients’ PD-L1 expression. This will help to bolster Keytruda’s position, as it is also already prescribed as a monotherapy for PD-L1-high patients in both squamous and non-squamous 1L NSCLC. With promising label expansions in both HNSCC and NSCLC allowing the use of Keytruda in a large number of patients, the next issues to be resolved are the question of how payers will be able to afford the expensive Keytruda combinations and whether patients will have to be stratified further in order to receive them.

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GlobalData (2017). PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) – Dynamic Market Forecast to 2025, August 2017, GDHC001FS

GlobalData (2018). Head and Neck Squamous Cell Carcinoma: Opportunity Analysis and Forecasts to 2026, March 2018, GDHC084POA

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