Datroway ivonescimab Phase III planned in first-line triple-negative breast cancerAstraZeneca, Daiichi Sankyo and Summit plan Datroway plus ivonescimab Phase III trial

Datroway ivonescimab combination trials are on the way. AstraZeneca and Daiichi Sankyo have signed a clinical collaboration with Summit Therapeutics to test Datroway (datopotamab deruxtecan) together with ivonescimab across multiple solid tumors, including lung and breast cancers, the companies announced on October 2, 2026. They plan to start with a Phase III trial in first-line triple-negative breast cancer (TNBC).

Each company will contribute its own medicine and share trial costs while keeping development and commercial rights to its own drug, Reuters reported. The agreement builds on AstraZeneca’s $2 billion equity investment in Summit, announced in September 2026.

Key Takeaways: Datroway Ivonescimab Collaboration

  • AstraZeneca, Daiichi Sankyo and Summit will evaluate Datroway with ivonescimab in multiple tumor types, beginning with a Phase III study in first-line TNBC.
  • Lung cancer is also a planned setting, along with other solid tumors.
  • Each company supplies its own drug, shares trial costs and retains its own development and commercial rights.
  • No enrollment target, primary endpoint or first-patient date has been disclosed for the breast cancer study.
  • Ivonescimab is investigational in the United States and Europe, so the combination is experimental.

What Are Datroway and Ivonescimab?

Datroway (datopotamab deruxtecan) is a TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Ivonescimab is Summit’s investigational PD-1/VEGF bispecific antibody, licensed from Akeso for the United States, Canada, Europe and Japan. It was first approved in China in May 2024.

Datroway Ivonescimab Collaboration at a Glance

ItemDetail
PartnersAstraZeneca, Daiichi Sankyo and Summit Therapeutics
AnnouncedOctober 2, 2026
MedicinesDatroway (TROP2 ADC) and ivonescimab (PD-1/VEGF bispecific antibody)
First planned studyPhase III in first-line triple-negative breast cancer
Other settingsLung cancer and other solid tumors
CostsShared by the three companies
RightsEach company keeps development and commercial rights to its own medicine
SupplyDaiichi Sankyo manufactures and supplies Datroway under its existing collaboration with AstraZeneca
Diagram of the planned Datroway plus ivonescimab collaboration: Datroway, a TROP2-directed antibody drug conjugate, combined with ivonescimab, a PD-1/VEGF bispecific antibody, with a first Phase III in first-line triple-negative breast cancer followed by lung cancer and other solid tumors
Overview of the planned Datroway plus ivonescimab studies. Source: AstraZeneca, Daiichi Sankyo and Summit announcements.

Why Start With Triple-Negative Breast Cancer?

TNBC lacks the receptors targeted by many breast cancer drugs, which limits treatment options. Datroway is already approved in more than 30 countries and regions for adults with unresectable or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitors, according to the companies. AllSci noted that pairing it with ivonescimab gives the combination a potential route into immunotherapy-containing first-line regimens.

Mugglehead reported that either AstraZeneca or Daiichi Sankyo will sponsor the planned breast cancer study. The announcements did not give an enrollment target, primary endpoint or start date.

How the Deal Fits AstraZeneca’s and Summit’s Strategy

AstraZeneca announced a $2 billion strategic equity investment in Summit on September 28, 2026, intended in part to support combination studies of ivonescimab with AstraZeneca medicines. AllSci reported that this includes a separate agreement pairing ivonescimab with AstraZeneca’s Claudin 18.2 ADC sonesitatug vedotin in gastrointestinal cancers, and planned future combinations with other AstraZeneca oncology assets.

For Summit, the collaboration extends a program that already spans several Phase III trials, including HARMONi, HARMONi-3, HARMONi-7 and HARMONi-GI3, according to its annual report. Summit president and co-chief executive Maky Zanganeh said beginning with a Phase III study in first-line TNBC represents an important expansion of the company’s global development program into breast cancer and a path for additional solid tumor settings. Datroway, for its part, has a global program of more than 20 trials, including eight Phase III trials in lung cancer and five in breast cancer.

What Is Still Unknown

The companies have not published design details for the combination trials, and the safety of pairing an antibody drug conjugate with a PD-1/VEGF bispecific antibody has not been shown in a Phase III setting. In our assessment, the scientific logic is to combine a targeted cytotoxic payload with immune and anti-angiogenic blockade, but the combination will need to show a clear survival or response benefit over current first-line options, with acceptable tolerability, before it changes practice.

Regulatory status also matters. Ivonescimab is not approved in Summit’s license territories, including the United States and Europe, and the outcome of its separate regulatory review in EGFR-mutated lung cancer cannot predict whether the breast cancer combination will work.

What the Collaboration Means for Patients

The combination is experimental and is available only through clinical trials once they open. People with TNBC or lung cancer who are interested in research options can ask their oncologist about eligibility and watch ClinicalTrials.gov for the new studies. For related coverage of cancer drug development and deals, read our reports on the end of Foghorn and Lilly’s FHD-909 program, Novartis’s licensing deal with Abogen and India’s PRIP scheme funding for pharma R&D, or browse our pharmaceutical news.

Frequently Asked Questions About the Datroway Ivonescimab Collaboration

What is the Datroway ivonescimab collaboration?

It is a clinical trial collaboration among AstraZeneca, Daiichi Sankyo and Summit Therapeutics to test Datroway with ivonescimab across multiple solid tumors, beginning with a Phase III trial in first-line triple-negative breast cancer.

Which cancers will be studied?

The companies named lung and breast cancers, starting with first-line TNBC, and said additional solid tumor settings could follow.

Who pays for the trials?

The three companies will share trial costs. Each supplies its own medicine and keeps development and commercial rights to it.

Is the Datroway and ivonescimab combination approved?

No. The combination is experimental. Datroway is approved for certain patients with unresectable or metastatic TNBC, but ivonescimab is investigational in the United States and Europe.

What is Datroway approved for?

According to the companies, Datroway is approved in more than 30 countries and regions for adults with unresectable or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor therapy.

How we reported this: this article is based on announcements from AstraZeneca, Daiichi Sankyo and Summit, Reuters coverage, trade reports and Summit’s annual report linked above. Trial design details have not been disclosed. Last updated October 2, 2026. It is for information only and is not medical or investment advice.

By Simone Lamb

Simone Lamb is the editor of Medgadget.in, covering healthcare technology, medical devices, and the latest developments in digital health.

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