FDA approves first-line use of Merck & Co.'s Keytruda in non-small-cell lung cancer

Merck & Co. announced that the FDA approved Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours have high PD-L1 expression as determined by an authorised test, with no EGFR or ALK genomic tumour aberrations. The company noted that the drug is the only anti-PD-1 therapy to be cleared in the first-line treatment setting for these patients.

"Keytruda improved survival, compared to traditional chemotherapy, in patients with non-small-cell lung cancer whose tumours express high levels of PD-L1," remarked Roger Perlmutter, president of Merck Research Laboratories. Perlmutter added "the approval of Keytruda for the first-line treatment of metastatic non-small-cell lung cancer has the potential to change the treatment landscape for these patients."

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.

The approval was based on data from the Phase III KEYNOTE-024 study, which was recently presented at the European Society for Medical Oncology (ESMO) congress. Results showed that Keytruda was superior to chemotherapy for both the primary endpoint of progression-free survival and the secondary goal of overall survival. Specifically, Keytruda reduced the risk of progression or death by 50 percent compared to chemotherapy and resulted in a 40-percent reduction in the risk of death compared to chemotherapy.

Merck also noted that the FDA approved a labeling update to include data from the KEYNOTE-010 trial in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumours express PD-L1 as determined by an authorised test, with disease progression on or after platinum-containing chemotherapy. The company noted that patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.

In 2014, Keytruda became the first PD-1 inhibitor cleared in the US, with the FDA granting the therapy accelerated approval for advanced or unresectable melanoma. The drug is also authorised in the US for the treatment of certain patients with recurrent or metastatic head and neck squamous cell carcinoma. Meanwhile, last week, Merck announced that a Phase III study of Keytruda in patients with previously treated advanced urothelial cancer met the primary endpoint of overall survival.

For related analysis, see ViewPoints: Christmas comes early for Merck & Co., and Physician Views Poll Results: Oncologists impressed by Merck & Co.'s Keytruda/chemotherapy combo in first-line NSCLC.

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