FDA Clears Merck's Welireg Plus Lenvima for Advanced Kidney Cancer

The FDA has approved Merck's Welireg in combination with Eisai's Lenvima for adults with advanced clear cell renal cell carcinoma who have progressed on a PD-1 or PD-L1 inhibitor. This marks the first approved pairing of a HIF-2 alpha inhibitor with a tyrosine kinase inhibitor in this setting.

The approval is based on data from the Phase III Litespark-011 trial, which involved 747 patients. The combination reduced the risk of disease progression or death by 26% compared to cabozantinib, extending median progression-free survival to 14.6 months versus 10.6 months and lifting objective response rate to 53% versus 40%.

In other news, three drug-discovery platform deals have closed this week, with combined potential value topping $4.7 billion. Novo Nordisk is partnering with Nanexa in a deal worth more than $1.33 billion to apply Nanexa's Pharmashell atomic layer deposition delivery platform to as many as five peptide programs in obesity, type 2 diabetes, and other cardiometabolic conditions.

Separately, Genentech is teaming with Earendil Labs, worth more than $1.5 billion, to apply Earendil's AI-driven protein design platform to multiple bispecific antibody oncology programs, and Roche is partnering with Atavistik Bio in a deal worth more than $1.9 billion to apply its Amps allosteric drug discovery platform against multiple small molecule targets in cardiovascular, renal, and metabolic disease.