FDA grants approval to Merck & Co.'s Keytruda as first-line combination therapy in NSCLC

Merck & Co. announced Wednesday that the FDA awarded accelerated approval to Keytruda (pembrolizumab), in combination with Eli Lilly's Alimta (pemetrexed) and carboplatin, for use in previously untreated patients with metastatic non-squamous non-small-cell lung cancer (NSCLC) irrespective of PD-L1 expression. The approval follows clearance of the drug as monotherapy for patients with metastatic NSCLC whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations. 

Merck Research Laboratories president Roger Perlmutter remarked "the improved responses seen with the Keytruda plus [Alimta]/carboplatin regimen are significant, and highlight the importance of finding new approaches that address the unmet needs of patients with metastatic non-squamous [NSCLC]." 

The approval was supported by safety and efficacy data from the KEYNOTE-021 study's G cohort released in October last year, which showed that Keytruda plus Alimta and carboplatin was associated with an overall response rate of 55 percent, compared to 29 percent for Alimta and carboplatin alone. In addition, Merck noted that the three-drug regimen reduced the risk of death or disease progression by 47 percent. "It was a small trial but the results were really quite striking," commented Roy Baynes, head of global clinical development for Merck Research Labs.

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.

Keytruda, which had sales of $1.4 billion last year, was initially granted accelerated approval by the FDA in 2014 for the treatment of advanced or unresectable melanoma, becoming the first PD-1 inhibitor approved in the US. The drug was later authorised for use in certain patients with recurrent or metastatic head and neck squamous cell carcinoma, while the therapy was approved earlier this year for the treatment of certain adults and children with refractory classical Hodgkin lymphoma.

Commenting on the news, Leerink Partners analyst Seamus Fernandez said "this is the key game changer for Keytruda," adding that he expects physician acceptance to be "pretty robust." Shares in the company roses as much as 3.2 percent on the approval.

For related analysis, see ViewPoints: Merck & Co. continues to win the key plays in immuno-oncology race, and Physician Views Poll Results: Keytruda's momentum in NSCLC.

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