AstraZeneca, Daiichi Sankyo, and Summit to Combine Datroway, Ivonescimab

AstraZeneca and Daiichi Sankyo announced October 2, 2026, a clinical collaboration with Summit Therapeutics Inc to evaluate datopotamab deruxtecan (Datroway) in combination with ivonescimab across multiple tumor types, including lung and breast cancers.¹ The companies plan to begin with a phase 3 trial in 1st-line triple-negative breast cancer (TNBC).

What is the rationale for combining Datroway and ivonescimab?

Datopotamab deruxtecan is a TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca, while ivonescimab is a bispecific antibody that blocks programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF) in a single molecule.¹

"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, PhD, executive vice president, Oncology Hematology R&D, AstraZeneca, in a company press release.¹ "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."

What are the terms of the collaboration?

Each company will contribute its own medicine to the planned combination trials, which will be sponsored by AstraZeneca or Daiichi Sankyo, with all 3 companies sharing trial costs and each retaining development and commercial rights to its respective drug.¹ The agreement builds on a separately announced AstraZeneca-Summit collaboration evaluating ADC combinations and on an AstraZeneca equity investment supporting multiple ivonescimab combination studies, including a separate agreement pairing ivonescimab with AstraZeneca's sonesitatug vedotin, with further ivonescimab combinations planned.²

"This collaboration...advances our ambition for ivonescimab to become the global PD-1/VEGF partner of choice for novel combinations," said Maky Zanganeh, DDS, president and co-CEO of Summit Therapeutics, in the release.¹ "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."

What is known about ivonescimab's clinical profile so far?

Ivonescimab is approved in China for non-small cell lung cancer (NSCLC), and a biologics license application seeking US approval in epidermal growth factor receptor (EGFR)-mutated NSCLC is under FDA review. In a phase 3, randomized, double-blind trial in China, ivonescimab outperformed pembrolizumab in patients with programmed cell death ligand 1 (PD-L1)-positive NSCLC.³ The drug is also being studied in phase 3 trials spanning small cell lung, biliary tract, bladder, head and neck squamous cell, colorectal, and pancreatic cancers, in addition to TNBC. Datopotamab deruxtecan, meanwhile, already carries approvals in more than 30 countries for TNBC and more than 45 countries for HR-positive, HER2-negative breast cancer.¹

How does this fit the broader push toward combination cancer therapies?

The companies' strategy echoes a theme oncology researchers have raised about single-modality cancer treatments. "Vaccines themselves aren't necessarily going to take care of the entire problem. We're going to have to have multimodalities to eradicate a tumor," Keith L. Knutson, PhD, professor of immunology at Mayo Clinic, pointed out to BioPharm International® in a previous interview on combination strategies in oncology.⁴ Though Dr Knutson was speaking about cancer vaccines, the same logic underlies pairing an ADC with a PD-1/VEGF bispecific.

What are the limitations?

The planned phase 3 TNBC trial has not yet been registered publicly, so its design, size, and timeline are not yet known. Ivonescimab's FDA approval in EGFR-mutated NSCLC remains under review and is not necessarily guaranteed, and its China approval and Lancet-published data do not necessarily predict how the datopotamab deruxtecan combination will perform in a distinct trial population. Financial terms of the 3-way cost-sharing arrangement were not disclosed.

References

1. AstraZeneca. AstraZeneca and Daiichi Sankyo announce clinical collaboration with Summit Therapeutics to evaluate Datroway in combination with ivonescimab across multiple tumor types. Press release. Published October 2, 2026. Accessed October 2, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/az-ds-collaboration-with-summit-for-datroway.html
2. AstraZeneca. AstraZeneca announces strategic equity investment and clinical collaboration with Summit Therapeutics to advance leading ADC combination strategy in cancer. Press release. Published September 28, 2026. Accessed October 2, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-announces-equity-investment-summit.html
3. Xiong A, Wang L, Chen J, et al. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomized, double-blind, phase 3 study in China. Lancet. 2025;405(10481):839-849. doi:10.1016/S0140-6736(24)02722-3
4. Mirasol F. Combining cancer vaccines with checkpoint inhibitors may broaden tumor eradication, aay Mayo Clinic's Dr Knutson and CellxLife's Dr von Hofe. BioPharm International. Published August 27, 2026. Accessed October 2, 2026. https://www.biopharminternational.com/view/cancer-vaccines-checkpoint-inhibitors-tumor-eradication-mayo-clinic-knutson-cellxlife-von-hofe