On Tuesday, Merck & Co. Inc. (NYSE:MRK) and Eisai shared topline data from the Phase 3 LITESPARK-011 trial of the dual oral regimen of Welireg (belzutifan) plus Lenvima (lenvatinib).
The trial met one of its primary endpoints of progression-free survival (PFS) for patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy.
At a pre-specified interim analysis, Welireg plus Lenvima demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Exelixis Inc.’s (NASDAQ:EXEL) Cabometyx (cabozantinib).
PFS is the time during and after treatment that a disease, like cancer, does not get worse.
Compared to cabozantinib, the combination also showed a statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR).
A trend toward improvement in overall survival (OS), the study’s other primary endpoint, was observed; however, this result did not reach statistical significance at the time of this interim analysis.
Overall survival will be tested at a subsequent analysis.
The safety profiles of Welireg and Lenvima in this trial were consistent with those observed in previously reported studies for the individual therapies; no new safety signals were observed.
Concurrently, Merck released topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy (surgical removal of the kidneys).
In this study, Keytruda (pembrolizumab) and Welireg demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to Keytruda in combination with placebo.
The trial will continue to evaluate overall survival (OS), a key secondary endpoint.
MRK Price Action: Merck & Co shares were down 0.78% at $87.31 at the time of publication on Tuesday, according to Benzinga Pro data.
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