Merck & Co., Inc. (known as MSD outside the United States and Canada) and Eisai Co., Ltd. have announced encouraging results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating the efficacy of KEYTRUDA (pembrolizumab), an anti-PD-1 therapy by Merck, combined with LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor […]
Astellas Pharma Inc. has announced a significant milestone in cancer treatment with the European Commission (EC’s) approval of PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab). This approval authorizes the use of this combination therapy as a first-line treatment for adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-based chemotherapy. A New […]
Merck (NYSE: MRK), known as MSD outside the United States and Canada, has announced that Health Canada has granted approval for KEYTRUDA (pembrolizumab) in combination with enfortumab vedotin for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have not received prior systemic therapy for this condition. This decision […]
Kineta Inc. has announced the resumption of patient enrollment in its VISTA-101 Phase 1/2 clinical trial, which is evaluating the efficacy of KVA12123 in treating advanced solid tumors. This decision follows a significant agreement with TuHURA Biosciences, Inc., which includes the potential acquisition of Kineta’s KVA12123 VISTA blocking antibody along with associated rights and assets. […]
Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, has announced encouraging results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial. The study evaluates the effectiveness of eftilagimod alfa (efti) combined with Merck & Co., Inc.’s KEYTRUDA (pembrolizumab) in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (1L […]
In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded priority review status to its Supplemental New Drug Application (sNDA) for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for adults with previously untreated locally advanced […]
Merck & Co., Inc., a global healthcare leader, has recently unveiled groundbreaking results from its Phase 3 KEYNOTE-564 trial. This pivotal study demonstrates that KEYTRUDA, Merck’s innovative anti-PD-1 therapy, significantly reduces the risk of death by 38% compared to placebo, marking a milestone in adjuvant therapy for patients with renal cell carcinoma (RCC) post-nephrectomy. Presented […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]
Merck, known as MSD outside of the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for KEYTRUDA, its anti-PD-1 therapy. This approval, in combination with chemoradiotherapy (CRT), is for the treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA cervical cancer. The approval […]
Moderna, Inc. (NASDAQ: MRNA) and Merck (NYSE: MRK), also known as MSD outside the United States and Canada, today revealed follow-up data from their collaborative Phase 2b KEYNOTE-942/mRNA-4157-P201 study. This clinical trial evaluates mRNA-4157 (V940), an innovative individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, for patients with resected high-risk melanoma (stage […]