Merck, known as MSD outside of the US, and Canada, today announced that receipt of the US Food and Drug Administration (FDA) approval for WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor for the treatment of adult patients with advanced renal cell carcinoma (RCC).
This drug is intended for adult patients with RCC after a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
The FDA has given approval to the drug is based on statistically significant and clinically meaningful results from LITESPARK-005.
LITESPARK-005 is said to be the only trial in advanced RCC to particularly analyse patients who have advanced after a PD-1 or PD-L1 inhibitor and a VEGF-TKI.
In the study, WELIREG showed superior progression-free survival (PFS) versus everolimus in advanced RCC after treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, either given in sequence or in combination.
Furthermore, WELIREG showed an objective response rate (ORR) of 22% against 4% for everolimus.
Merck Research Laboratories senior vice president for global clinical development and head of late-stage oncology Dr. Marjorie Green said: “In 2021, WELIREG became the first HIF-2α inhibitor therapy approved in the U.S. for the treatment of adult patients with certain VHL disease-associated tumors and is now approved for eligible patients with advanced RCC.
“This approval of WELIREG marks the first new therapeutic class available for eligible patients with advanced RCC in nearly a decade, and was based on the statistically significant progression-free survival benefit observed in patients following treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI when compared to everolimus.”
Renal cell carcinoma (RCCs) is the most common type of kidney cancer, with about 9 out of 10 kidney cancer diagnoses being RCCs. This disease is found to be about twice as common in men than in women. Furthermore, about 15% of patients diagnosed with kidney cancer are at an advanced stage.