Merck & Co. said Tuesday that Keytruda (pembrolizumab) met the primary endpoints of overall survival (OS) and progression-free survival (PFS) in the Phase III KEYNOTE-826 trial as a first-line treatment in patients with persistent, recurrent or metastatic cervical cancer. The company indicated that the results will be submitted to regulatory authorities and presented at an upcoming medical meeting.
The study randomised 617 patients with persistent, recurrent or metastatic cervical cancer to receive first-line treatment with either Keytruda or placebo, both in combination with platinum-based chemotherapy with or without bevacizumab. The trial enrolled adults with persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix who had not been treated with systemic chemotherapy and who were no longer amenable to curative treatment.
Merck said that based on an interim analysis conducted by an independent data monitoring committee, the addition of Keytruda led to significant and clinically meaningful improvements in OS and PFS compared to placebo, regardless of PD-L1 status. The study's secondary endpoints include objective response rate and duration of response.
Roy Baynes, chief medical officer at Merck Research Laboratories, noted that this "is the first study to show positive results for immunotherapy in first-line persistent, recurrent or metastatic cervical cancer." Merck added that the safety profile of Keytruda in the trial was "consistent" with that observed in previously reported studies.
Meanwhile, the company noted that KEYNOTE-826 is the confirmatory trial for the current FDA accelerated approval of Keytruda as a second-line treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1. The clearance, which was granted in 2018, was based on data from the KEYNOTE-158 study, with results showing an objective response rate of 14.3%, including a complete response rate of 2.6%.
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