Merck Announces First Positive Phase 3 Results For WELIREG From LITESPARK-005

(RTTNews) - Merck (MRK) announced topline results from LITESPARK-005, a Phase 3 trial investigating WELIREG, Merck's oral hypoxia-inducible factor-2 alpha inhibitor, in certain previously treated patients with Advanced Renal Cell Carcinoma. In the trial, WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus, based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee. A statistically significant improvement in the trial's key secondary endpoint of objective response rate was also demonstrated. The company noted that a trend toward improvement in overall survival, a dual primary endpoint, was observed; however, this result did not reach statistical significance. The safety profile was consistent with that observed in previously reported studies.

LITESPARK-005 is part of a development program for WELIREG comprised of four Phase 3 trials in renal cell carcinoma, including LITESPARK-011 and LITESPARK-012, evaluating WELIREG in the second-line and treatment-naïve advanced disease settings, and LITESPARK-022, evaluating WELIREG in the adjuvant setting.

The company said the results will be presented at an upcoming medical meeting and shared with regulatory authorities.

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