LONDON: AstraZeneca and Daiichi Sankyo have entered a clinical collaboration agreement with Summit Therapeutics Inc. to test a combination of two cancer drugs across multiple tumor types, including lung and breast cancers, the companies announced.

The collaboration will evaluate Datroway, also known as datopotamab deruxtecan, alongside ivonescimab. The companies plan to begin with a Phase III trial in first-line triple-negative breast cancer.

Datroway is a TROP2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

“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,” said Susan Galbraith, executive vice president of oncology hematology R&D at AstraZeneca. “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 of Summit Therapeutics, said the collaboration reflects growing confidence in ivonescimab’s potential as a next-generation immunotherapy.

“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,” Zanganeh said.

John Tsai, global head of R&D at Daiichi Sankyo, said the company aims to maximize its antibody drug conjugate portfolio through strategic combinations.

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

AstraZeneca recently announced an equity investment to help support clinical collaborations evaluating combinations with ivonescimab, including the Datroway agreement, a separate agreement with Summit for combinations with sonesitatug vedotin, and planned future collaborations with other AstraZeneca cancer medicines.

Ivonescimab is a bispecific antibody that combines immunotherapy through PD-1 blockade with anti-angiogenesis effects from VEGF blocking in a single molecule. It is approved in China to treat certain patients with non-small cell lung cancer, and a Biologics License Application seeking approval in EGFR-mutated NSCLC is under review by the U.S. Food and Drug Administration. The drug is being studied in Phase III trials for NSCLC, small cell lung cancer, biliary tract cancer, bladder cancer, TNBC, head and neck squamous cell carcinoma, colorectal cancer and pancreatic cancer.

Datroway is approved in more than 30 countries for adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, based on results from the TROPION-Breast02 trial. It also is approved in more than 45 countries for certain patients with HR-positive, HER2-negative breast cancer, and in the U.S. and several other countries for locally advanced or metastatic EGFR-mutated NSCLC.

More than 20 trials are underway evaluating Datroway across multiple cancers, including eight Phase III trials in lung cancer, five Phase III trials in breast cancer and two trials in urothelial cancer.

AstraZeneca and Daiichi Sankyo entered a global collaboration in March 2019 to jointly develop and commercialize Enhertu and in July 2020 for Datroway, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC.