First and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for these adult patients with advanced RCC This approval of WELIREG marks the first time a new treatment has been approved in a novel therapeutic class in advanced RCC since 2015 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The approval is based on statistically significant and clinically meaningful results from LITESPARK-005, which is the only trial in advanced RCC to specifically evaluate patients who have progressed following a PD-1 or PD-L1 inhibitor and a VEGF-TKI. In the trial, WELIREG
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At a pre-specified interim analysis in LITESPARK-005, WELIREG reduced the risk of disease progression or death compared to everolimus First Phase 3 trial to show positive results in patients with advanced RCC following both immune checkpoint and anti-angiogenic therapies in later lines of treatment Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus. These late-breaking data are
Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies If approved, WELIREG would provide a new, novel mechanism of action for patients with advanced RCC in need of new options 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 and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies. The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful
First positive Phase 3 results for WELIREG from LITESPARK-005 showed statistically significant improvements in PFS versus everolimus in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. In the trial, WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee. A statistically significant improvement in the trial’s key secondary endpoint of objective
First Phase 3 survival data from KEYNOTE-A39/EV-302 support potential benefit of combination approach in previously untreated locally advanced or metastatic urothelial cancer; data are selected for ESMO Presidential Symposium Session and official Press Briefings Key data to be presented for KEYTRUDA® (pembrolizumab) in earlier stages of cancer across multiple tumor types, including presentation of overall survival results from KEYNOTE-671, and new and updated data from KEYNOTE-A18, KEYNOTE-522 and KEYNOTE-756 First Phase 3 data from LITESPARK-005 trial highlight potential of WELIREG® (belzutifan) in certain previously treated patients with advanced renal cell carcinoma Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, from Oct. 20-24.
KEYTRUDA is the first therapy to show a statistically significant improvement in OS as adjuvant therapy in patients with RCC at a higher risk of recurrence following nephrectomy New OS results build on the significant disease-free survival benefit previously reported from the KEYNOTE-564 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo. The safety profile of KEYTRUDA was consistent with that
KEYNOTE-564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC Late-breaking OS results selected for the official Press Program at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These late-breaking data are being presented during an oral session for the first time today at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA359) and are included in the official ASCO GU Press Program. At the third pre-specified interim analysis (median
New event-free survival data from KEYNOTE-671 show potential of KEYTRUDA® (pembrolizumab)-based regimen as a perioperative treatment in earlier stages of lung cancer Final overall survival data reinforce role of KEYTRUDA plus LENVIMA® (lenvatinib, in collaboration with Eisai) in advanced renal cell carcinoma (CLEAR/KEYNOTE-581) First-time distant metastasis-free survival data (KEYNOTE-942/mRNA-4157-P201) and data from trial investigating MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate, showcase promise of Merck’s pipeline and importance of strategic collaborations Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s
Longer-term survival results underscoring role of KEYTRUDA® (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189) Seven-year survival from SOLO-1 and final overall survival (OS) results from PAOLA-1 highlight role of LYNPARZA® (olaparib) in first-line maintenance of advanced ovarian cancer First presentation of KEYTRUDA in combination with an antibody-drug conjugate (enfortumab vedotin) (Phase 1b/2 EV-103/KEYNOTE-869 Cohort K) Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that research spanning 16 different cancer types will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, France from Sept. 9-13. The breadth of data showcases the continued impact of Merck’s portfolio of oncology medicines and the potential of Merck's innovative oncology pipeline. “We are proud to present longer-term survival data in patients with lung, ovarian, melanoma and
Data from studies of six medicines and pipeline candidates in more than 25 cancers to be presented Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data for six approved medicines and pipeline candidates in more than 25 types of cancer will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 3-7. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA; WELIREG™ (belzutifan); LYNPARZA ® (olaparib, in collaboration with AstraZeneca); and LENVIMA ® (lenvatinib, in collaboration with Eisai). Additionally, Merck will present data from its diverse pipeline of immuno-therapeutic candidates, including the investigational anti-LAG-3 therapy favezelimab and the investigational anti-ILT3 therapy MK-0482. “The medicines in our broad portfolio have helped transform the treatment of many advanced cancers, but patients continue to need new treatment