Partners Merck, Sharp & Dohme (MSD, NYSE: MRK) and Eisai (TYO: 4523) have announced the latest results from the Phase III LEAP-015 study, which evaluated the combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) with Eisai’s kinase inhibitor Lenvima (lenvatinib) plus chemotherapy. The study focused on the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma.
Study Results and Implications
Interim results from the LEAP-015 study showed that the Keytruda plus Lenvima-based regimen demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to standard-of-care chemotherapy. These improvements were observed for both PFS, one of the study’s dual primary endpoints, and ORR, a key secondary endpoint. However, overall survival (OS), the other primary endpoint, was not reached at the final analysis. The safety profile of the regimen remained consistent with previous findings.
Expanding Indications and Future Research
The Keytruda/Lenvima combination is already registered in the US, European Union (EU), Japan, and other regions for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial cancer. The positive results from the LEAP-015 study further highlight the potential of this combination therapy in treating various types of cancer. MSD and Eisai are also exploring the use of Keytruda/Lenvima in hepatocellular carcinoma (HCC), esophageal cancer, and other indications, underscoring their commitment to advancing cancer treatment options through innovative combination therapies.-Fineline Info & Tech
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