Merck's KEYTRUDA and WELIREG Combination Therapy Approved by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 12 2026
0mins
Merck announced the U.S. Food and Drug Administration approved KEYTRUDA and KEYTRUDA QLEX, Merck's anti-PD-1 therapies, each in combination with WELIREG, Merck's first-in-class, oral hypoxia-inducible factor-2 alpha inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2alpha inhibitor combination regimens. The approvals are based on results from the pivotal Phase 3 LITESPARK-022 trial. LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival, the trial's primary endpoint, reducing the risk of disease recurrence, metastasis or death by 28% for patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared to KEYTRUDA plus placebo. The estimated 24-month DFS rate was 81% with KEYTRUDA plus WELIREG compared to 74% with KEYTRUDA plus placebo. Median DFS was not reached in either arm. Overall survival results were not yet mature at this interim analysis. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA.
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Analyst Views on MRK
Wall Street analysts forecast MRK stock price to rise
16 Analyst Rating
11 Buy
5 Hold
0 Sell
Moderate Buy
Current: 115.440
Low
95.00
Averages
119.53
High
139.00
Current: 115.440
Low
95.00
Averages
119.53
High
139.00
About MRK
Merck & Co., Inc. is a global health care company that delivers health solutions through its prescription medicines, including biologic therapies, vaccines and animal health products. Its Pharmaceutical segment includes human health pharmaceutical and vaccine products. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers. It sells these human health vaccines primarily to physicians, wholesalers, distributors and government entities. Its Animal Health segment discovers, develops, manufactures and markets a range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all livestock and companion animal species. Its products include KEYTRUDA (pembrolizumab) injection, for intravenous use; WELIREG (belzutifan) tablets, for oral use; Ohtuvayre (ensifentrine) and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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