Keytruda combination improves OS for HER2-positive advanced gastric cancer in phase III trial

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The phase III KEYNOTE-811 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival for the first-line treatment of patients with human epidermal growth factor receptor 2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

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FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.

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