Drug Research
Drug Discovery & Development

Immunomedics, AstraZeneca collaborate in first-line triple-negative breast and urothelial cancers

PBR Staff Writer Published 24 July 2018

Immunomedics has entered into a clinical collaboration with AstraZeneca and its global biologics research and development arm MedImmune in first-line triple-negative breast and urothelial cancers.

The partnership will 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.”
Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response.

As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.

Source: Company Press Release