en.Wedoany.com Reported - The U.S. FDA has approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab with berahyaluronidase alfa) in combination with WELIREG (belzutifan) for the adjuvant treatment of adult patients with clear cell renal cell carcinoma (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. This marks the first approval of WELIREG in early-stage ccRCC and the first approved PD-1 plus HIF-2α inhibitor combination.

This approval is based on a randomized, double-blind Phase 3 LITESPARK-022 trial (enrolling a total of 1,841 patients). Trial results showed that KEYTRUDA in combination with WELIREG met the primary endpoint of investigator-assessed disease-free survival (DFS), reducing the risk of disease recurrence, metastasis, or death by 28% compared to KEYTRUDA plus placebo (HR=0.72; 95% CI 0.59–0.87; p=0.0003). The estimated 24-month DFS rate was 81% (95% CI 0.78–0.83) in the combination therapy group, compared to 74% (95% CI 0.71–0.77) in the KEYTRUDA plus placebo group; median DFS was not reached in either group. Overall survival data were not yet mature at the time of the interim analysis.

Patients were randomized in a 1:1 ratio to receive WELIREG 120 mg orally once daily in combination with KEYTRUDA 400 mg intravenously every six weeks for up to 9 cycles (total of 54 weeks), or KEYTRUDA in combination with oral placebo. Eligible patients were those at intermediate-high or high risk of recurrence, or with M1 no evidence of disease status, who had not received prior systemic therapy for advanced RCC.

In the LITESPARK-022 trial, 30% of patients receiving the combination therapy experienced serious adverse reactions, and 1.1% experienced fatal adverse reactions. Permanent discontinuation of WELIREG due to adverse reactions occurred in 27% of patients. The most common adverse reactions (incidence ≥25%) included decreased hemoglobin (95%), increased ALT (57%), fatigue (49%), increased AST (46%), lymphopenia (38%), and increased alkaline phosphatase (29%). The prescribing information for WELIREG includes a boxed warning for embryo-fetal toxicity, and it may cause severe anemia and severe hypoxia; monitoring of pregnancy status, hemoglobin, and oxygen saturation is required during treatment, and effective non-hormonal contraception is recommended.

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