MRK Reports Mixed Keytruda Combo Study Data in Gastroesophageal Cancer

Core Insights - Merck and Eisai announced data from the phase III LEAP-015 study, evaluating the combination of Keytruda and Lenvima with chemotherapy for treating gastroesophageal adenocarcinoma [1][2] - The study showed a significant improvement in progression-free survival (PFS) but failed to meet the overall survival (OS) endpoint [3] - Keytruda remains a key product for Merck, generating over $21 billion in sales in the first nine months of 2024, accounting for around 50% of the company's pharmaceutical sales [8][9] Study Results - The LEAP-015 study compared the Keytruda plus Lenvima regimen against standard chemotherapy for first-line treatment of HER2-negative gastroesophageal adenocarcinoma [2] - The interim analysis indicated a statistically significant improvement in PFS, while the final analysis did not meet the OS endpoint [3] - The combination also showed a significant improvement in objective response rate, a key secondary endpoint [4] Market Performance - Merck's stock has declined by 21.2% over the past year, contrasting with a 2.2% decline in the industry [5] - The Keytruda plus Lenvima combination is already approved in multiple regions for advanced endometrial and renal cell carcinoma [6] Future Prospects - Merck is exploring the Keytruda and Lenvima combination across various tumor types through the LEAP clinical program [7] - The company is developing strategies to sustain Keytruda's growth, including innovative immuno-oncology combinations and a subcutaneous formulation [10] - Keytruda is expected to continue its growth trajectory, particularly in early-stage non-small cell lung cancer, despite patent expiration concerns post-2028 [9]