AstraZeneca and Daiichi Sankyo have entered into a clinical collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway (datopotamab deruxtecan) in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin with a phase 3 trial in first-line Triple-Negative Breast Cancer (TNBC).

Datroway is a specifically engineered TROP2-directed DXd Antibody Drug Conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, “Central to our strategy to transform cancer outcomes is harnessing the power of immunotherapy and Antibody Drug Conjugate combinations to drive deeper, more durable responses. We believe the combination of Datroway and ivonescimab has the potential to make a meaningful difference in multiple tumor types including lung and breast cancers.”

Dr. Maky Zanganeh, President and Co-Chief Executive Officer, Summit Therapeutics, said, “We believe this collaboration with Daiichi Sankyo and AstraZeneca reflects increasing conviction in ivonescimab’s potential as a foundational next-generation immunotherapy and advances our ambition for ivonescimab to become the global PD-1 / VEGF partner of choice for novel combinations. Beginning with a phase 3 study in first-line Triple Negative Breast Cancer, this collaboration represents an important expansion of Summit’s global development program into breast cancer and a path for additional solid tumor settings.”

John Tsai, Global Head, R&D, Daiichi Sankyo, said, “At Daiichi Sankyo, we are focused on maximising the potential of our DXd Antibody Drug Conjugate portfolio through innovative combinations and strategic collaborations that support the continued advancement of our pipeline. We are encouraged by the opportunity to explore ivonescimab in combination with Datroway to potentially deliver clinically meaningful benefit to patients.”

Under the terms of this agreement, each company will contribute their respective medicine for the planned combination trials which will be sponsored by AstraZeneca or Daiichi Sankyo. AstraZeneca, Daiichi Sankyo and Summit will each contribute to trial costs and each company will retain development and commercial rights to their respective medicines.

AstraZeneca also recently announced an equity investment which will help in part to support clinical collaborations evaluating combinations with ivonescimab including this agreement for Datroway, AstraZeneca’s separate agreement with Summit for combinations with sonesitatug vedotin (Sone-Ve), and planned future clinical collaborations intended to evaluate combinations with other AstraZeneca cancer medicines, including additional ADCs.

Ivonescimab is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Ivonescimab is approved to treat certain patients with Non-Small Cell Lung Cancer (NSCLC) in China, and a Biologics License Application (BLA) seeking approval in EGFR-mutated NSCLC is under review by the US Food and Drug Administration (FDA).

Ivonescimab is currently being studied in phase 3 clinical trials in NSCLC, Small Cell Lung Cancer (SCLC), biliary tract cancer, bladder cancer, TNBC, Head and Neck Squamous Cell Carcinoma (HNSCC), colorectal cancer, and pancreatic cancer.