Merck & Co. pulls European application for Keytruda as first-line non-squamous NSCLC treatment

Merck & Co. on Friday announced that it has withdrawn its European application seeking approval of Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC) in combination with carboplatin and Eli Lilly's Alimta (premetrexed). Shares in the drugmaker fell as much as about 9 percent on the news. 

Merck noted that the submission was supported by data from Cohort G of the KEYNOTE-021 trial. Study results unveiled last month showed that the addition of Keytruda to Alimta and carboplatin was associated with an objective response rate of 56.7 percent after a median of 18.7 months of follow-up, compared with 31.7 percent for Alimta and carboplatin alone. Data also revealed that the three-drug regimen cut the risk of death or progression by 46 percent, with a median progression-free survival for the Keytruda plus Alimta and carboplatin arm of 19 months, compared to 8.9 months for Alimta and carboplatin. 

The drugmaker said that "Merck is confident in the clinical data from this rigorously conducted trial, which demonstrated significant improvements in overall response rate and progression-free survival for the Keytruda combination regimen compared to chemotherapy alone." In May, the FDA awarded accelerated approval to Keytruda, in combination with Alimta and carboplatin, for use in previously untreated patients with metastatic non-squamous NSCLC irrespective of PD-L1 expression. The clearance by the agency was based on data from Cohort G of the KEYNOTE-021 study.

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On Friday, Merck also noted that it is amending the Phase III KEYNOTE-189 trial to include overall survival as a co-primary endpoint, with a new study completion date of February 2019. The trial is evaluating platinum-Alimta chemotherapy with or without Keytruda in patients with first-line metastatic non-squamous NSCLC. Company spokeswoman Pam Eisele said that although no decisions have been made about when the filing in Europe will be resubmitted, there will be opportunities for the company to conduct interim analyses of the KEYNOTE-189 study.

According to Sanford Bernstein analyst Tim Anderson, European approval of Keytruda for the first-line treatment of patients with metastatic non-squamous NSCLC in combination with carboplatin and Alimta had been expected next year. Merck separately disclosed on Friday that quarterly sales of Keytruda exceeded $1 billion for the first time. "Keytruda is almost completely reliant on the performance in first-line lung cancer," commented Leerink Partners analyst Seamus Fernandez, adding Merck needs "to identify other growth drivers for the business."

For further analysis, read ViewPoints: Slow and steady – Merck & Co. sticks to cautious approach with Keytruda.

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