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AstraZeneca, Daiichi Sankyo to Discuss Pan-Cancer Enhertu Activity With Regulators

NEW YORK – AstraZeneca and Daiichi Sankyo on Monday said Enhertu (trastuzumab deruxtecan) met its prespecified objective response rate target in the Phase II DESTINY-PanTumor02 trial, and as a result, the drugmakers will share the findings with regulatory authorities.

In the DESTINY-PanTumor02 study, AstraZeneca and Daiichi Sankyo are evaluating the antibody-drug conjugate as a potential treatment for patients with advanced, previously treated HER2-expressing solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers, and rare tumors. To be eligible for the trial, patients must be out of treatment options after their cancers progressed on the last treatment. Patients can receive local or central testing to establish the HER2-expression status of their cancers. 

The trial has enrolled 268 patients across sites in Asia, Europe, and North America. AstraZeneca and Daiichi Sankyo are primarily interested in tracking patients' responses to Enhertu and secondary endpoints such as duration of response, disease control, progression-free survival, and overall survival, among other efficacy measures.

Enhertu is currently approved in the US for HER2-positive metastatic breast cancer and metastatic patients with low HER2 expression. However, in conducting the DESTINY-PanTumor02 trial, the drug's sponsors have shown interest in expanding Enhertu's use to other HER2-expressing tumors.

"The clinically meaningful responses seen in the DESTINY-PanTumor02 trial reaffirm our belief in the potential of Enhertu across multiple HER2-expressing cancers," Ken Takeshita, Daiichi Sankyo's global head of R&D, said in a statement. "The results seen so far across multiple cohorts of the trial will inform next steps of our broad development program as we look to bring this important medicine to as many patients as quickly as possible."

AstraZeneca and Daiichi Sankyo said they will present the data at an upcoming medical meeting.