Follow-up data from the phase IIb randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with Keytruda in patients with resected high-risk melanoma (stage 3/4) following complete resection.
FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
The phase III KEYNOTE-522 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, met its overall survival endpoint, in combination with chemotherapy as pre-operative treatment and then continuing as a single agent after surgery for the treatment of patients with high-risk early-stage triple-negative breast cancer.
Iovance Biotherapeutics Inc. a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte therapies for patients with cancer, has updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, for the upcoming 2024 ASCO Annual Meeting.
Merck announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the phase III KeyVibe-010 trial.
The phase III KEYNOTE-B21 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival for the treatment of patients with newly diagnosed, high-risk endometrial cancer after surgery with curative intent.
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.
Health Canada approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.