India Pharma Outlook Team | Tuesday, 21 October 2025
A new therapy developed by AstraZeneca and Daiichi Sankyo has demonstrated significant success in a major clinical trial targeting an aggressive and difficult-to-treat form of breast cancer, potentially paving the way for regulatory approval.
The experimental antibody-drug conjugate, named Datroway, showed a notable survival benefit in the phase 3 trial. According to AstraZeneca, patients treated with Datroway lived a median of 23.7 months, compared to 18.7 months for those receiving standard chemotherapy.
Furthermore, Datroway nearly doubled the time patients lived without their disease worsening, with a median progression-free survival of 10.8 months, versus 5.6 months in the chemotherapy group. The trial, called TROPION-Breast02, included nearly 650 participants diagnosed with inoperable metastatic breast cancer for which immunotherapy was not a viable option. These patients had triple-negative breast cancer (TNBC) — a particularly challenging subtype where the cancer cells lack three common protein markers (estrogen receptor, progesterone receptor, and HER2) that most targeted therapies act upon.
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Datroway takes a different approach by targeting the TROP2 protein, which is found in several cancer types, including TNBC. This mechanism allows the drug to deliver a potent chemotherapy agent directly to cancer cells expressing this protein, potentially improving both efficacy and safety compared to traditional chemotherapy.
With these positive results, Datroway now emerges as a promising treatment option for a patient group that has had limited therapeutic choices and typically poor outcomes.
“For triple negative patients, whose disease moves very progressively every day, every week, every month, [this data] is a huge hope that science is delivering for them,” Mohit Manrao, head of AstraZeneca’s U.S. oncology division, said in an interview.