Daiichi Sankyo and Merck Partner for Global MK-6070 Development and Commercialization

Daiichi Sankyo and Merck have expanded their global co-development and co-commercialization agreement to include Merck’s MK-6070, a T-cell engager targeting delta-like ligand 3 (DLL3). The companies will jointly develop and commercialize MK-6070 globally, except in Japan, where Merck retains exclusive rights. Merck will handle the manufacturing and supply of MK-6070.

MK-6070 targets DLL3, a Notch ligand highly expressed in small cell lung cancer (SCLC) and neuroendocrine tumors, and is currently under evaluation in a phase 1/2 clinical trial. The companies plan to study MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC patients, among other combinations. Merck acquired MK-6070 through its acquisition of Harpoon Therapeutics.

Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, emphasized that expanding their oncology pipeline with a DLL3 T-cell engager aligns with Daiichi Sankyo’s strategy to improve cancer care globally. The addition of MK-6070 offers potential synergies with their existing collaborations, particularly with ifinatamab deruxtecan, demonstrating their commitment to advancing new medicines.

Dean Y. Li, MD, PhD, President of Merck Research Laboratories, highlighted the urgent need for new treatment approaches for small cell lung cancer, a fast-growing form of lung cancer. He expressed excitement to further their collaboration with Daiichi Sankyo and evaluate the combination of MK-6070 and ifinatamab deruxtecan as a novel treatment strategy targeting the biology of SCLC and other cancers.

Financially, Merck will receive an upfront payment of $170 million and has met a contingent quid obligation from the original agreement. Both companies will share research and development (R&D) and commercialization expenses, as well as profits globally, except in Japan. Merck will record global sales for MK-6070.

The DLL3 ligand, which inhibits the Notch signaling pathway, is highly expressed in SCLC and other neuroendocrine tumors like melanoma, small cell bladder cancer, and metastatic castration-resistant prostate cancer, with minimal expression in normal tissues. DLL3 is considered a promising therapeutic target, and various treatment approaches are being explored.

MK-6070, an investigational DLL3-directed tri-specific T-cell engager, is in phase 1/2 clinical trials as a monotherapy for advanced cancers associated with DLL3 expression and in combination with atezolizumab for SCLC patients. In March 2022, the U.S. FDA granted Orphan Drug Designation to MK-6070 for treating SCLC.

The collaboration between Daiichi Sankyo and Merck began in October 2023, focusing on co-developing and co-commercializing patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), except in Japan, where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo also handles manufacturing and supply.

Daiichi Sankyo is a global healthcare company that aims to develop new standards of care and improve quality of life. With over 120 years of experience, the company uses its scientific expertise to create innovative medicines for cancer, cardiovascular diseases, and other conditions with high unmet needs.

Merck, known as MSD outside the U.S. and Canada, focuses on discovering innovative treatments for cancer. They are committed to advancing science to improve patient outcomes and addressing barriers to clinical trial participation and treatment access. With a broad pipeline and extensive clinical development programs, Merck aims to shape the future of oncology. Merck also emphasizes diversity, sustainability, and responsible operations to support global health.

In summary, Daiichi Sankyo and Merck's expanded collaboration around MK-6070 aims to advance new treatment options for small cell lung cancer and other neuroendocrine tumors, leveraging their combined expertise in oncology to address unmet medical needs and improve patient outcomes worldwide.