Merck notches fourth lung cancer approval in Europe for flagship Keytruda

Merck’s keystone immunotherapy Keytruda has won yet another lung cancer approval in Europe, this time as the first line of defense for patients with metastatic squamous non-small cell lung cancer (NSCLC), on the basis of trial data that showed the drug — as part of a chemotherapy combo — cut the risk of death by 36% versus chemotherapy alone.

The checkpoint inhibitor is already approved as a monotherapy or as part of a combo in various forms of lung cancer: as a frontline treatment in patients with metastatic nonsquamous NSCLC; first-line treatment in metastatic squamous or nonsquamous NSCLC in adults whose tumors have high PD-L1 expression; and in locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.

Lung cancer is the leading cause of cancer death globally, according to the WHO. The two main types of lung cancer are non-small cell and small cell, and NSCLC accounts for about 85% of all cases. Within NSCLC, 40% of cases are adenocarcinomas, 25 to 30% are squamous cell carcinomas and 10 to 15% are large cell carcinomas. Overall, the NSCLC market is poised to grow to $14.6 billion by 2024, according to GlobalData estimates.

The approval was based on data from KEYNOTE-407, a late-stage 559-patient study evaluating Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel compared with carboplatin-paclitaxel or nab-paclitaxel alone. The twin main goals are overall survival (OS) and and progression-free survival (PFS).

Data showed the Keytruda combo significantly improved OS, reducing the risk of death by 36% compared to chemotherapy alone (HR=0.64; p<0.0008) and improved PFS, with a reduction in the risk of progression or death by 44% compared to chemotherapy alone (HR=0.56; p<0.0001).

The blockbuster treatment, which takes the brakes off the immune system to better fight cancer, is approved for use in a plethora of oncology indications including melanoma, head and neck cancer, lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, hepatocellular carcinoma and Merkel cell carcinoma. It generated about $7.2 billion in sales last year for Merck $MRK.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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