Merck & Co (MSD) has received approval from the US Food and Drug Administration (FDA) for both Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Welireg (belzutifan), as adjuvant treatment for adults with renal cell carcinoma with a clear cell component (ccRCC).
This approval covers patients with ccRCC who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
This marks the initial approval for Welireg in earlier-stage ccRCC and the first approved combinations featuring programmed cell death protein 1 (PD-1) and hypoxia-inducible factor 2-alpha (HIF-2α) inhibitors.
The approvals are based on data from the pivotal Phase III LITESPARK-022 trial, which enrolled 1,841 patients.
The study showed that Keytruda and Welireg improved the primary endpoint of disease-free survival (DFS) by reducing the risk of recurrence, metastasis, or death by 28% in patients at intermediate-high or high risk, following nephrectomy, compared to Keytruda plus placebo.
The estimated 24-month DFS rate was 81% with Keytruda plus Welireg and 74% with Keytruda plus placebo. Median DFS was not reached in either group at the time of analysis.
Overall survival data were not mature. The effectiveness of Keytruda Qlex was determined using evidence from controlled studies with Keytruda, along with data from MK-3475A-D77, comparing the pharmacokinetic, efficacy, and safety profiles.
Welireg prescribing information includes a boxed warning about embryo-foetal risk and requires verified pregnancy status before initiation.
Patients are to be counselled regarding the risks and to avoid hormonal contraception, which may be rendered ineffective. Welireg can cause severe anaemia and hypoxia, requiring careful monitoring and potentially intervention.
Keytruda Qlex is contraindicated in patients with hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any excipients.
Both Keytruda and Keytruda Qlex are associated with the risk of severe immune-mediated reactions and other serious complications, including transplant rejections, infusion reactions, and increased mortality in certain patient groups.
Merck research laboratories global clinical development vice-president Dr Catherine Pietanza said: “Reflecting on my own experience as a clinical oncologist, I know the significant impact that improved disease-free survival can have on the lives of patients.
“These approvals demonstrate Merck’s commitment to pursuing innovative treatment options that may help these patients experience longer periods without disease.”
In April 2026, MSD and Google Cloud formed a multi-year partnership investing up to $1bn to advance agentic AI enterprise transformation.
