Merck & Co.'s Welireg bags FDA approval for advanced RCC
15 Dec 2023
Phase 3Drug ApprovalClinical ResultPriority ReviewAcquisition
The FDA on Thursday announced the approval of Merck & Co.'s Welireg (belzutifan) for the treatment of adults with advanced renal cell carcinoma (RCC) previously treated with PD-1/L1 and VEGF-targeted therapies.
This is the oral HIF-2α inhibitor’s second US approval, the first one being in 2021 for the treatment of cancers associated with von Hippel-Lindau disease. Welireg’s latest approval “marks the first new therapeutic class available for eligible patients with advanced RCC in nearly a decade,” remarked Marjorie Green, head of late-stage oncology at Merck Research Laboratories.
The current approval, which follows a priority review, was based on findings from the head-to-head Phase III LITESPARK-005 trial, comparing Welireg and the mTOR blocker everolimus in 746 patients with unresectable, locally advanced or metastatic clear cell RCC who progressed after treatment with prior PD-1/L1 and VEGF-targeted therapies, either in sequence or in combination.
Survival benefit awaited
In the study, Welireg demonstrated superior progression-free survival (PFS) compared with everolimus, reducing the risk of disease progression or death by 25%, although median PFS was 5.6 months in both treatment arms. The FDA added that while overall survival (OS) results are currently immature, "no trend towards a detriment was observed."
Meanwhile, Welireg's safety profile in the trial was consistent with previously reported studies, with the drug’s label carrying a boxed warning about embryo-foetal toxicities.
Extensive development programme
Welireg - acquired by Merck through the takeover of Peloton Therapeutics in 2019 - is undergoing an extensive development programme in RCC, which includes the Phase III LITESPARK-011 and LITESPARK-012 trials assessing the drug in second-line and treatment-naïve scenarios. Additionally, LITESPARK-022 is investigating Welireg in combination with Keytruda (pembrolizumab) in the adjuvant setting.
A key opinion leader (KOL) interviewed by Firstword earlier this year had expressed optimism about Welireg’s prospects in second-line given its perceived tolerability advantage relative to tyrosine kinase inhibitors. The KOL was also hopeful that a positive trend on the mature OS data of LITESPARK-005 would satisfy prescribers.
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