Merck Submits sNDA for Belzutifan (Welireg) as Second Indication in Advanced Renal Cell Carcinoma

On September 19, MSD announced that the supplemental New Drug Application (sNDA) for Belzutifan (brand name: Welireg) had been granted Priority Review by the FDA, with the indication beingAdvanced Renal Cell Carcinoma (RCC) Treated with PD-(L)1 Inhibitors and Anti-VEGF AgentsThe PDUFA date is January 17, 2024.

This sNDA is primarily based on the positive results of the Phase III LITESPARK-005 study. The study is a randomized, open-label clinical trial that enrolled 746 patients with advanced RCC whose disease had progressed after prior treatment with PD-(L)1 inhibitors and anti-VEGF therapies. It aims to compare the efficacy and safety of Belzutifan (120 mg once daily) versus Everolimus (10 mg once daily).

The results showed that, after receiving Belzutifan treatment, patients' progression-free survival (PFS) was significantly prolonged, and their overall survival (OS) showed a trend of extension but without statistical significance. MSD is still evaluating OS.

In addition to the LITESPARK-005 study, MSD has also initiated three Phase III clinical trials of Belzutifan:

• LITESPARK-011 Study: Combination of Pembrolizumab and LenvatinibFirst-line TreatmentPatients with advanced RCC;

• LITESPARK-012 Study: Combination with LenvatinibSecond-line treatmentPatients with advanced RCC;

• LITESPARK-022 Study: In Combination with PembrolizumabAdjuvant TherapyPatients with clear cell renal cell carcinoma (ccRCC) who have undergone nephrectomy.

Belzutifan is a small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor that reduces the transcription and expression of HIF-2α target genes associated with cell proliferation, angiogenesis, and tumor growth. In August 2021, Belzutifan received FDA accelerated approval based on Phase II clinical data for the treatment ofPatients with VHL-associated renal cell carcinoma, central nervous system hemangioblastoma, or pancreatic neuroendocrine tumors who do not require immediate surgery, becoming the world's first and currently only approved HIF-2α inhibitor to be marketed. Currently, there are only seven HIF-2α inhibitors in clinical development globally, one of which comes from the Chinese pharmaceutical company Betta Pharmaceuticals.

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of kidney cancer diagnoses. The incidence of renal cell carcinoma in men is about twice that in women. In the United States, around 15% of kidney cancer patients are diagnosed at an advanced stage.

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