Merck's Welireg Scores FDA Nod as Second-Line Kidney Cancer Treatment

Merck has secured FDA approval for its drug Welireg to be used in combination with Lenvima as a second-line treatment for kidney cancer. This marks a significant expansion of Welireg's indications, which was originally approved for third-line use. The combo has shown promising results in the phase 3 Litespark-011 trial, reducing patients' risk of progression or death by 26% compared to Cabometyx.

The study also showed that Welireg-Lenvima extended median progression-free survival by four months to 14.6 months and had a higher tumor response rate at 53%, compared to 40% for Cabometyx. While the overall survival analysis did not show a statistically significant benefit, the combo did favor patients living a median of 33.7 months versus 28.6 months in the control arm.

Experts predict rapid uptake for Welireg in the second line, but it will face competition from other treatments like Cabometyx and Opdivo. Merck is also testing Welireg with Exelixis' next-generation TKI zanzalintinib in a phase 3 trial.