The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.
Merck announced positive topline results from the pivotal phase III MK-3475A-D77 trial.
EC approves Keytruda combinations for endometrial carcinoma indication, FIGO 2014 stage III-IVA locally advanced cervical cancer
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EC granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first and only folate receptor alpha-directed antibody drug conjugate medicine approved in the EU, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
Addition of the immunotherapy drug pembrolizumab (Keytruda) to standard of care for patients with advanced soft tissue sarcoma of the limb significantly improved disease-free survival, according to the results of the SU2C-SARC032 clinical trial led by researchers from the University of Pittsburgh, UPMC, Duke University, and Princess Margaret Cancer Centre.
Promising preliminary results from an ongoing investigator-initiated phase I clinical trial evaluating the safety and efficacy of a combined regimen of Keytrua (pembrolizumab) and Lymphir (denileukin diftitox-cxdl or E7777) in patients with recurrent solid tumors were announced.
The phase III KEYNOTE-689 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma met its primary endpoint of event-free survival.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
