Key Takeaways
- A breast cancer drug being developed by AstraZeneca failed to “achieve statistical significance” in helping patients live longer than with chemotherapy in a phase 3 trial.
- The trial included over 700 patients with inoperable or metastatic breast cancer.
- The company said it will present the new data to regulators who are weighing approval of the drug. Its shares fell Monday morning.
British drugmaker AstraZeneca (AZN) said Monday that a Phase 3 trial of a developmental drug failed to achieve “statistical significance” in improving the length of time patients with certain types of breast cancer lived.
The disappointing result for datopotamab deruxtecan (Dato-DXd) is the second for AstraZeneca this month. Another Phase 3 trial failed to improve on the current standard of care for lung cancer patients.
AstraZeneca’s American depositary receipts (ADRs) fell more than 1% in recent trading Monday. The stock is up in 2024, though off August highs.
Dato-DXd Has Uncertain Regulatory Future
The drug, being jointly developed with Japanese drugmaker Daiichi Sankyo, has produced positive results in earlier trials. AstraZeneca said Monday that it planned to submit the new data to regulatory agencies. Analysts said the new data makes approval “less likely,” Bloomberg reported.
AstraZeneca executive vice president of oncology research and development Susan Galbraith said the breast cancer treatment landscape has “advanced remarkably” in recent years, and said the new trial and past positive results show the “evidence of the clinical value” of the drug.
The trial included over 700 patients with inoperable or metastatic breast cancer.