AstraZeneca’s Phase III Study on Dato-DXd in Advanced Breast Cancer: Key Insights for Investors

AstraZeneca is conducting a Phase III clinical study to evaluate the efficacy and safety of experimental drug Dato-DXd, with or without durvalumab, in treating advanced triple-negative breast cancer. The study aims to improve progression-free survival and overall survival in patients. The outcome of this study could significantly impact AstraZeneca's stock performance and position the company favorably in the oncology market.

AstraZeneca has recently announced an update on their ongoing Phase III clinical study, titled ‘A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator’s Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer’ [1]. The study, launched on November 23, 2023, aims to evaluate the efficacy and safety of the experimental drug Dato-DXd, with or without durvalumab, against standard chemotherapy options combined with pembrolizumab in treating patients with advanced triple-negative breast cancer.

The interventions being tested include Dato-DXd and durvalumab, both experimental drugs, and a combination of chemotherapy drugs (paclitaxel, nab-paclitaxel, gemcitabine, carboplatin) with pembrolizumab as the active comparator. These treatments are intended to improve progression-free survival and overall survival in patients. The study is a randomized, open-label, multicenter study with a parallel intervention model, with participants allocated to one of three arms: Dato-DXd with durvalumab, investigator’s choice of chemotherapy with pembrolizumab, or Dato-DXd alone in selected countries. The primary purpose is treatment, with no masking involved.

The study began on November 23, 2023, and is currently recruiting participants. The primary completion and estimated completion dates have not been disclosed, but the last update was submitted on August 11, 2025. These dates are crucial for tracking the study’s progress and potential market impact. The outcome of this study could significantly influence AstraZeneca’s stock performance, as positive results may enhance investor confidence and position the company favorably against competitors in the oncology market. The involvement of Daiichi Sankyo as a collaborator further underscores the study’s importance.

The study is ongoing, and further details are available on the ClinicalTrials portal.

References:
[1] https://www.tipranks.com/news/company-announcements/astrazenecas-phase-iii-study-on-dato-dxd-in-advanced-breast-cancer-key-insights-for-investors