Merck & Co. announced Tuesday that a late-stage study of Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC) met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). The drugmaker indicated that Keytruda is the first PD1 inhibitor in combination to show an OS benefit in NSCLC.
The KEYNOTE-189 trial randomised 614 patients with advanced or metastatic non-squamous NSCLC, regardless of PD-L1 expression, to receive Keytruda in combination with Eli Lilly's Alimta (pemetrexed) and cisplatin or carboplatin, or Alimta and cisplatin or carboplatin alone. Merck noted that based on an interim analysis, treatment with Keytruda in combination with Alimta plus platinum chemotherapy resulted in significantly longer OS and PFS than Alimta plus platinum chemotherapy alone.
The company indicated that data from the study will be presented at an upcoming medical meeting and submitted to regulatory authorities.
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In October last year, Merck amended the KEYNOTE-189 trial to include OS as a co-primary endpoint, with a new study completion date of February 2019. However, at the time, company spokeswoman Pam Eisele said that there will be opportunities for the company to conduct interim analyses of the study.
The change to the KEYNOTE-189 study came at the same time as Merck disclosed that it withdrew an application in Europe seeking approval of Keytruda for the first-line treatment of patients with metastatic non-squamous NSCLC in combination with carboplatin and Alimta. The submission was supported by objective response rate data from the KEYNOTE-021 trial, as well as results showing that the three-drug regimen cut the risk of death or progression by 46 percent versus Alimta and carboplatin. For related analysis, see ViewPoints: EMA sheds further light on key Keytruda data in shadow of Roche's big reveal.
At the time, Eisele indicated that no decisions had been made about when the filing in Europe will be resubmitted. 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.
Last month, Roche's Genentech unit announced detailed results from the Phase III IMpower150 study, showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death by 38 percent compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous NSCLC. The company noted that early results for the co-primary endpoint of OS are also "encouraging."
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