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 […]
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 […]
Imugene Limited (ASX: IMU), a prominent player in the immuno-oncology field, has released an encouraging update on its Phase 1 MAST trial, which evaluates the safety and efficacy of the novel oncolytic virus, CF33-hNIS (VAXINIA), used both as monotherapy and in combination with pembrolizumab (KEYTRUDA). As the trial progresses, noteworthy outcomes are emerging, particularly in […]
Gilead Sciences, Inc. announced early data showcasing promising clinical activity of Trodelvy in combination with Merck’s KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). The data was presented at the IASLC 2023 World Conference on Lung Cancer and focuses on patients without actionable genomic alterations. EVOKE-02 Preliminary Analysis: Notable Response Rates Across […]
ENB Therapeutics, a biotechnology firm working on therapeutics targeting the endothelin B receptor (ETBR), announced the completion of its international Phase 1 ENBOLDEN-101 trial enrollment. The trial aims to investigate the safety and efficacy of ENB-003, the company’s lead product, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). This Phase 1/2a study is an open-label, […]
Moderna and Merck announced that the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with the latter’s lung cancer drug KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation by the US Food and Drug Administration (FDA). The breakthrough therapy designation for the combination is for its use as adjuvant treatment of high-risk melanoma in patients […]
Cue Biopharma has been granted fast track designation for CUE-101 from the US Food and Drug Administration (FDA) for the treatment of a type of head and neck squamous cell carcinoma (HNSCC) both as a monotherapy and in combination with Merck’s pembrolizumab (KEYTRUDA). The fast track designation for the interleukin 2 (IL-2)-based biologic is in […]
PDS Biotechnology has secured fast track designation to its PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) from the US Food and Drug Administration (FDA) for the treatment of HPV16-positive head and neck cancer that is recurrent or metastatic. The US-based clinical-stage immunotherapy company is currently evaluating the combination of PDS0101 and KEYTRUDA in the VERSATILE-002 […]