First Filing Acceptance for an Anti-PD-1 Therapy in Cervical Cancer
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
Immutep Limited (ASX:IMM) (IMMP) (“Immutep” or the “Company”) has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Immutep’s lead immunotherapy product candidate eftilagimod alpha (“efti” or “IMP321”) with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a new clinical trial that will evaluate the combination in several different solid tumours.
Merck & Company and Tokyo-based Eisai Inc. have signed a strategic collaboration deal to develop and commercialize Lenvima (lenvatinib mesylate) with Merck’s anti-PD-1 drug Keytruda (pembrolizumab).
Keytruda (pembrolizumab) was the main bright spot for Merck as it weathered blows from the NotPetya cyber attack, new competition and pricing pressures in hepatitis C.
Just a few months after Merck’s monster May for Keytruda, which featured three FDA approvals, the New Jersey drugmaker is back with another green light.
Merck, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Merck has paused new enrolment in two studies assessing its immunotherapy Keytruda treatment in combination with other therapies in multiple myeloma to address safety concerns.
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