The approval was based on the data from an open-label, randomised, active-controlled LITESPARK-005 clinical trial in which Welireg showed statistically significant and clinically meaningful results
Merck’s office in Pennsylvania, US. (Credit: Montgomery County Planning Commission from Wikimedia Commons)
Merck has received the US Food and Drug Administration (FDA) approval for Welireg to treat adult patients with advanced renal cell carcinoma (RCC) following certain therapies.
Welireg is an oral inhibitor of hypoxia-inducible factor-2 alpha (HIF-2α).
The FDA has approved Welireg for RCC patients following 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 approval was based on the data from an open-label, randomised, active-controlled LITESPARK-005 clinical trial, which is the only such trial.
The statistically significant and clinically meaningful results showed that Welireg achieved superior progression-free survival (PFS) against everolimus.
Merck, known as MSD outside of the US and Canada, said the results were found in advanced RCC patients following treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, administered in sequence or combination.
In addition, Welireg demonstrated an objective response rate (ORR) of 22% compared to 4% for everolimus.
Merck Research Laboratories global clinical development late-stage oncology senior vice president and head Marjorie Green said: “In 2021, Welireg became the first HIF-2α inhibitor therapy approved in the US for the treatment of adult patients with certain VHL disease-associated tumours 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.”
LITESPARK-005 randomised 746 patients in 1:1 to receive Welireg or everolimus orally once daily.
The PFS were the major efficacy endpoints and additional endpoints included ORR.
With this approval, WELIREG has become the first approved therapy for advanced RCC since 2015.
In 2021, it was approved by the FDA for the treatment of a type of von Hippel-Lindau (VHL) disease in adults.