Merck announced that the combination of its immunotherapy Keytruda (pembrolizumab) with the investigational drug WELIREG (belzutifan) reduced the risk of disease recurrence or death by 28% compared with Keytruda monotherapy in patients with earlier‑stage renal cell carcinoma (RCC). The 28% relative risk reduction, with a hazard ratio of 0.72 and a p‑value of 0.0003, was derived from the first pre‑specified interim analysis of the phase 3 LITESPARK‑022 trial, which evaluated the adjuvant use of Keytruda plus WELIREG after nephrectomy. The data were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium held February 26‑28, 2026.
The result is strategically significant for Merck because it expands the therapeutic potential of WELIREG beyond its current approvals for advanced RCC and VHL disease‑associated tumors. By demonstrating a clinically meaningful benefit in the adjuvant setting, the combination could become a new revenue driver and help mitigate the impact of Keytruda’s patent expiration in 2028. Merck’s broader pipeline transformation plan, which aims to generate over $50 billion in new revenue opportunities by the mid‑2030s, is reinforced by this data.
WELIREG is already approved for advanced RCC following prior immunotherapy and VEGF‑TKI treatments. The LITESPARK‑022 trial extends its indication to earlier‑stage disease, and Merck has submitted a supplemental application to the U.S. FDA for the combination with a target action date of June 19, 2026. The FDA has granted priority review status, underscoring the potential regulatory and commercial impact of the findings.
Management emphasized the unmet need in early‑stage RCC and the company’s leadership in genitourinary oncology. Dr. M. Catherine Pietanza, vice president of global clinical development, noted that “KEYTRUDA monotherapy remains an important treatment choice, but many patients remain at risk of recurrence.” She added that the LITESPARK‑022 results “demonstrate the potential to provide additional treatment options for those most in need.” Dr. Marjorie Green, senior vice president of oncology, highlighted Merck’s commitment to advancing standards of care in the GU cancer landscape. Chairman and CEO Rob Davis expressed confidence in Merck’s long‑term growth strategy and its efforts to defend Keytruda’s patent estate beyond 2028.
The combination therapy could capture a larger share of the RCC market and help offset the anticipated loss of exclusivity for Keytruda. Analysts estimate that success in the adjuvant setting could translate into over $6 billion in annual revenue for Merck. The result also supports Merck’s recent reorganization of its human health business into an Oncology Business Unit and a Specialty, Pharma & Infectious Diseases Unit, allowing the company to focus resources on high‑growth oncology opportunities.
In summary, the 28% reduction in recurrence risk with Keytruda plus WELIREG is a clinically meaningful milestone that strengthens Merck’s oncology portfolio, diversifies its revenue base, and positions the company to navigate the Keytruda patent cliff while pursuing its long‑term growth objectives.
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