Merck (MSD) has announced findings from the pivotal Phase III LITESPARK-022 trial, assessing the combination of Keytruda (pembrolizumab) and Welireg (belzutifan) as adjuvant therapy for patients with clear cell renal cell carcinoma (RCC) after nephrectomy.
The multi-centre, randomised, double-blind Phase III trial compared adjuvant Welireg (120mg orally once daily for about one year) in combination with Keytruda (400mg intravenously every six weeks for about one year) against Keytruda plus placebo in these patients.
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It enrolled 1,841 patients and measured disease-free survival (DFS) as the primary endpoint, with safety, overall survival (OS), and quality of life as key secondary endpoints.
At the first pre-specified interim analysis, after a median follow-up of 28.4 months, the combination significantly improved DFS, the primary endpoint, by reducing the risk of disease recurrence or death by 28% versus Keytruda alone.
Median DFS was not reached in either arm; the estimated 24-month DFS rate was 80.7% (Keytruda and Welireg) and 73.7% (Keytruda plus placebo). The study will continue to assess overall survival.
The safety profile was consistent with previous studies; no new safety signals emerged. Of those enrolled, 69.5% in the combination arm and 71.1% in the Keytruda plus placebo arm completed treatment.
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By GlobalDataMSD research laboratories, global clinical development vice-president Dr M Catherine Pietanza said: “These findings represent the first positive Phase III data for Welireg in earlier stages of disease, as well as the first positive Phase III results for a HIF‑2α inhibitor and immunotherapy combination, reinforcing our commitment to exploring novel treatment approaches to improve upon established treatment paradigms for patients in need.”
Based on these data, the US Food and Drug Administration (FDA) accepted priority review applications for the combination’s adjuvant use in RCC with clear cell component at increased recurrence risk post-nephrectomy, setting a target action date of 19 June 2026.
Last month, Synthekine entered a clinical trial partnership and supply agreement with MSD to investigate STK-012 in combination with Keytruda and chemotherapy in patients with first-line, PD-L1-negative nonsquamous non-small cell lung cancer.
