Merck (NYSE:MRK) and its partner Eisai have announced disappointing results from two late-stage clinical studies involving a combination of their cancer therapies in patients with specific types of metastatic non-small cell lung cancer (NSCLC). Both studies failed to meet their dual primary endpoints of overall survival (OS) and progression-free survival (PFS).
- LEAP-006 Study: This study evaluated the combination of Merck’s Keytruda, Eisai’s Lenvima, pemetrexed, and chemotherapy as a first-line treatment for certain adult patients with metastatic, nonsquamous NSCLC.
- LEAP-008 Study: This study assessed Keytruda plus Lenvima as a second-line therapy for patients with metastatic NSCLC whose disease had progressed on a combination of chemotherapy and anti-PD-1/-L1 immunotherapy.
Both LEAP-006 and LEAP-008 studies also did not show a statistically significant improvement in the objective response rate (ORR), a key secondary endpoint in both studies.
It has not been confirmed whether Merck and Eisai will continue to develop the drug for these two NSCLC indications. The companies are currently conducting a full evaluation of the data from both studies and plan to share the results.
Merck’s shares have declined by 4.2% year-to-date, in contrast to the industry’s growth of 5.7%.
The combination of Keytruda and Lenvima is already approved in the United States, Europe, Japan, and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma.
Despite setbacks in the LEAP-006 and LEAP-008 studies, Merck and Eisai are continuing to study the combination in various tumor types, including hepatocellular carcinoma, head and neck cancer, gastric cancer, and esophageal cancer, across multiple clinical trials.
This latest setback follows a series of disappointments for Merck and Eisai involving the Keytruda/Lenvima combination. Last month, they announced the closure of the phase III LEAP-010 study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) due to a lack of overall survival benefit. In April, they discontinued the phase III LEAP-003 study in unresectable or metastatic melanoma after it failed to meet its OS endpoint.
Despite these challenges, Merck and Eisai are persevering with the combination for other indications under the LEAP program.
In a separate announcement, Merck, in partnership with Seagen (NASDAQ:SGEN), reported positive top-line results from a late-stage study (KEYNOTE-A39/EV-302) of the combination therapy of Seagen’s Padcev with Keytruda for the treatment of previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The study achieved its co-primary endpoints of OS and PFS. The FDA had previously granted accelerated approval for this combination, and the study aims to confirm this approval with full regulatory clearance.
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