Merck's KEYTRUDA and WELIREG Show Promising Results in Kidney Cancer Treatment
- Clinical Trial Results: At the 2026 American Society of Clinical Oncology (ASCO) meeting, Merck presented results from the LITESPARK-022 Phase 3 trial, demonstrating that the combination of KEYTRUDA and WELIREG significantly improved disease-free survival in renal cell carcinoma patients, reducing the risk of recurrence or death by 28% (HR=0.72, p=0.0003), offering new hope for kidney cancer treatment.
- Significant Patient Benefit: In the first pre-specified interim analysis with a median follow-up of 28.4 months, the 24-month disease-free survival rate was 80.7% for the KEYTRUDA plus WELIREG arm, notably higher than the 73.7% for KEYTRUDA monotherapy, providing a new treatment option for high-risk patients that could reshape clinical practice.
- FDA Priority Review: Following the positive results from LITESPARK-022, the FDA has accepted priority review applications for the combination of WELIREG with KEYTRUDA, with a target action date set for June 19, 2026, which could provide more effective treatment options for kidney cancer patients if approved.
- Good Safety Profile: The safety profile of the KEYTRUDA and WELIREG combination was consistent with previously reported studies, with no new safety signals observed, and 69.5% of patients completing the treatment, indicating good tolerability and enhancing its potential for clinical application.
Trade with 70% Backtested Accuracy
Analyst Views on MRK
About MRK
About the author
Merck & Co Inc: FDA Establishes PDUFA Deadline of June 19, 2026 for Welireg and Keytruda
Merck & Co. Announcement: Merck & Co. has set a new date of June 19, 2026, for the FDA's decision regarding the approval of its drug, Welireg.
Key Drug Focus: The drug Welireg is significant for its potential impact on treatment options, particularly in the context of key health conditions.
FDA Grants Priority Review for Combination of Welireg and Keytruda by Merck & Co Inc.
- Merck & Co. Update: Merck & Co. has received priority review from the FDA for its combination treatment involving Welireg and Keytruda.
- Regulatory Milestone: The FDA's acceptance of the priority review signifies a potential advancement in treatment options for patients.
Combination of KEYTRUDA® (PEMBROLIZUMAB) and WELIREG® (BELZUTIFAN) as Adjuvant Therapy Lowers Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Early-Stage Renal Cell Carcinoma Patients
Key Findings: The combination of Keytruda (pembrolizumab) and Welireg (belzutifan) has been shown to reduce the risk of disease recurrence or death by 28% compared to Keytruda alone in certain patients.
Target Patient Group: This treatment is particularly effective for patients with early-stage renal cell carcinoma (RCC).
MERCK & CO INC - FDA AGREES TO EVALUATE TWO ADDITIONAL NDAs FOR WELIREG IN COMBINATION WITH LENVIMA
FDA Review: The FDA has accepted a review of two supplemental applications from Merck & Co. for their product, Welireg.
Product Focus: The review pertains specifically to the use of Welireg in treating certain conditions, highlighting its potential benefits in the medical field.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA DEMONSTRATES NOTABLE ENHANCEMENT IN PROGRESSION-FREE SURVIVAL
- Significant Improvement: Merck & Co's Lenviima shows notable progress in free survival rates for patients.
- Clinical Advancements: The findings indicate a substantial enhancement in treatment outcomes for those undergoing therapy.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA LOWERS DISEASE PROGRESSION RISK BY 30%
Merck & Co. Announcement: Merck & Co. has reported that its drug, Lenviima, significantly reduces the risk of disease progression.
Efficacy Rate: The treatment is shown to lower the risk of disease progression by 30%, indicating a promising advancement in patient care.
Merck & Co Inc: FDA Establishes PDUFA Deadline of June 19, 2026 for Welireg and Keytruda
Merck & Co. Announcement: Merck & Co. has set a new date of June 19, 2026, for the FDA's decision regarding the approval of its drug, Welireg.
Key Drug Focus: The drug Welireg is significant for its potential impact on treatment options, particularly in the context of key health conditions.
FDA Grants Priority Review for Combination of Welireg and Keytruda by Merck & Co Inc.
- Merck & Co. Update: Merck & Co. has received priority review from the FDA for its combination treatment involving Welireg and Keytruda.
- Regulatory Milestone: The FDA's acceptance of the priority review signifies a potential advancement in treatment options for patients.
Combination of KEYTRUDA® (PEMBROLIZUMAB) and WELIREG® (BELZUTIFAN) as Adjuvant Therapy Lowers Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Early-Stage Renal Cell Carcinoma Patients
Key Findings: The combination of Keytruda (pembrolizumab) and Welireg (belzutifan) has been shown to reduce the risk of disease recurrence or death by 28% compared to Keytruda alone in certain patients.
Target Patient Group: This treatment is particularly effective for patients with early-stage renal cell carcinoma (RCC).
MERCK & CO INC - FDA AGREES TO EVALUATE TWO ADDITIONAL NDAs FOR WELIREG IN COMBINATION WITH LENVIMA
FDA Review: The FDA has accepted a review of two supplemental applications from Merck & Co. for their product, Welireg.
Product Focus: The review pertains specifically to the use of Welireg in treating certain conditions, highlighting its potential benefits in the medical field.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA DEMONSTRATES NOTABLE ENHANCEMENT IN PROGRESSION-FREE SURVIVAL
- Significant Improvement: Merck & Co's Lenviima shows notable progress in free survival rates for patients.
- Clinical Advancements: The findings indicate a substantial enhancement in treatment outcomes for those undergoing therapy.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA LOWERS DISEASE PROGRESSION RISK BY 30%
Merck & Co. Announcement: Merck & Co. has reported that its drug, Lenviima, significantly reduces the risk of disease progression.
Efficacy Rate: The treatment is shown to lower the risk of disease progression by 30%, indicating a promising advancement in patient care.
