Immunomedics Announces Clinical Collaboration With AstraZeneca in First-Line Triple-Negative Breast and Urothelial Cancers

Immunomedics announced a clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, to evaluate the safety and efficacy of the combination of Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, and Immunomedics’ lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, as a frontline treatment of patients with triple-negative breast cancer (TNBC) and urothelial cancer (UC).

“We are pleased to be partnering with AstraZeneca, a global leader in oncology drug development, to advance sacituzumab govitecan into potential first line of use, which could benefit a significantly larger patient population,” said Usama Malik, Chief Business Officer of Immunomedics.

David Berman, Senior Vice President, Head of IO Franchise, AstraZeneca said, “Our collaboration with Immunomedics will focus on the combination of sacituzumab govitecan with Imfinzi (durvalumab), expanding our efforts in triple-negative breast cancer and bladder cancer where unmet medical needs still exist. We believe combining Immunomedics’ antibody-drug conjugate, a late-stage agent that has demonstrated encouraging clinical activity, with Imfinzi will complement our existing clinical trial efforts in this area and maximize benefit to patients.”

Part one of the two-part Phase 1/2 studies will be co-funded by the two companies. Immunomedics will supply the study drug and AstraZeneca will utilize its existing clinical trial infrastructure to accelerate the enrollment of the sacituzumab govitecan and durvalumab combination. The trial design allows for rapid transition into randomized Phase 2 studies should the first part of these studies show promising data and the companies agree to proceed based on efficacy and safety results obtained.

“The collaboration with AstraZeneca is an important milestone in our strategy to establish sacituzumab govitecan as a foundational therapy in TNBC and UC,” commented Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. “The two agents have different modes of action, a largely non-overlapping safety profile and are expected to complement each other in their anticancer activities. We look forward to working with AstraZeneca to bring sacituzumab govitecan to cancer patients in earlier lines of therapy.”