AstraZeneca and Daiichi Sankyo are joining forces with Summit Therapeutics to test a new cancer drug combination across multiple tumour types, with a Phase III trial in first-line triple-negative breast cancer set to lead the programme.

 

The clinical collaboration will evaluate AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) alongside Summit’s ivonescimab, combining an antibody-drug conjugate (ADC) with a next-generation immunotherapy approach.

 

The companies plan to begin with a Phase III study in patients with previously untreated triple-negative breast cancer (TNBC), while also exploring the combination in other cancers, including lung and breast tumours.

 

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 tumour types including lung and breast cancers.”

 

For Summit, the agreement expands ivonescimab’s development programme into breast cancer and strengthens its strategy of pairing the drug with other cancer therapies.

 

Maky Zanganeh, President and Co-Chief Executive Officer of 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 III 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 tumour settings.”

 

Datroway is a TROP2-directed ADC developed by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. It is already approved in multiple countries for certain patients with TNBC, HR-positive/HER2-negative breast cancer and EGFR-mutated non-small cell lung cancer.

 

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 agreement, AstraZeneca, Daiichi Sankyo and Summit will each provide their respective medicines for the planned combination trials. The studies will be sponsored by AstraZeneca or Daiichi Sankyo, with all three companies contributing to trial costs.

 

Each company will retain development and commercial rights to its own medicine.

 

The collaboration comes after AstraZeneca recently announced an equity investment that will help support clinical collaborations involving ivonescimab. Those plans include AstraZeneca’s separate collaboration with Summit to evaluate ivonescimab with sonesitatug vedotin, as well as potential future combinations involving other AstraZeneca cancer medicines, including additional ADCs.

 

Ivonescimab is a bispecific antibody designed to combine PD-1 immunotherapy with VEGF inhibition in a single molecule. It is approved for certain patients with non-small cell lung cancer in China, while a US Biologics License Application for EGFR-mutated NSCLC is under review by the US Food and Drug Administration.

 

The drug is also being evaluated in Phase III trials across a broad range of cancers, including lung, breast, biliary tract, bladder, head and neck, colorectal and pancreatic cancers.

 

Meanwhile, Datroway is being studied in more than 20 clinical trials across multiple cancers. Its development programme includes eight Phase III lung cancer trials, five Phase III breast cancer trials and studies in urothelial cancer.

 

The latest collaboration adds another major combination strategy to the companies’ expanding efforts to test ADCs alongside immunotherapies in the treatment of solid tumours.