Merck & Co. announced that in a Phase III study, the addition of Keytruda (pembrolizumab) to chemotherapy failed to prolong overall survival (OS) or progression-free survival (PFS) versus chemotherapy alone as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma. However, the company noted that in the KEYNOTE-062 trial, Keytruda alone demonstrated non-inferiority to chemotherapy for OS in the entire intention-to-treat population of patients whose tumours expressed PD-L1.
The study randomised 763 patients with advanced gastric or gastroesophageal junction adenocarcinoma to treatment with Keytruda monotherapy, chemotherapy consisting of cisplatin plus 5-fluorouracil or capecitabine or a combination of Keytruda and chemotherapy. The primary endpoints of the study were OS in patients with PD-L1-expressing tumours in the Keytruda monotherapy and combination arms, as well as PFS in patients with PD-L1-expressing tumours in the combination arm.
Merck noted that the safety profile of Keytruda in the study was in line with previous findings in gastric cancer. The drugmaker added that results from the study will be presented at the American Society of Clinical Oncology (ASCO) meeting later this year and discussed with regulatory authorities.
Keytruda was previously authorised in the US for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumours express PD-L1 after the failure of at least two prior therapies.
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