This is the first positive Phase 3 trial for WELIREG in earlier-stage disease, the first positive results for a HIF-2α inhibitor and immunotherapy combination and the first study in earlier-stage disease, regardless of tumor type, to demonstrate a disease-free survival improvement compared to KEYTRUDA Based on these data, the U.S. FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX™ for the adjuvant treatment of certain patients with RCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from the pivotal Phase 3 LITESPARK-022 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG ® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, for patients with clear cell renal cell carcinoma (RCC) following
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This is the first positive Phase 3 trial of a HIF-2 alpha inhibitor in combination with a multi-targeted tyrosine kinase inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor Based on these data, the U.S. FDA has accepted for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG ® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA ® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of patients with advanced renal cell
First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting LITESPARK-022 is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG ® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. "KEYTRUDA monotherapy given
First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy compared with cabozantinib in a Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG ® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA ® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, met one of its primary endpoints of progression-free survival (PFS) for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy. At a pre-specified
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR). “PPGL, sometimes referred to as pheo para, is a rare condition affecting up
WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has conditionally approved WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; The treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies. The EC approval of these two
Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy in the U.S. for eligible patients with advanced PPGL Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL). The sNDA is based on objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial, which will be presented at an upcoming medical meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target
If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the European Union Positive opinion granted based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; The treatment of adult patients with advanced clear cell renal cell carcinoma (RCC)
WELIREG is the first and only systemic therapy approved in China for adult patients with certain VHL disease-associated tumors Decision marks first approval for WELIREG in China and 17th approval of WELIREG for these patients globally Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) in China has approved WELIREG ® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. WELIREG is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor and is the first and only approved HIF-2α inhibitor in China. This approval is based on objective response rate (ORR) and median duration of response (DOR) results from the Phase 2 LITESPARK-004 trial and is the 17th approval
ALAMEDA, CALIF. & RAHWAY, N.J., Oct. 14, 2024 – Exelixis, Inc. (Nasdaq: EXEL) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) in a Phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma (HNSCC), and zanzalintinib with WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in a Phase 1/2 trial and two Phase 3 pivotal trials for the treatment of patients with renal cell carcinoma (RCC). “This collaboration underscores our belief in zanzalintinib’s potential to drive patient benefit in combination with immunotherapy or targeted therapy in HNSCC and RCC indications that have unmet clinical need,” said Amy Peterson, M.D., executive vice