AstraZeneca-Daiichi Sankyo Datroway gets USFDA nod for previously treated Metastatic HR Positive, HER2 Negative Breast Cancer

DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and

AstraZeneca. DATROWAY is the second DXd ADC approved in the U.S. based on Daiichi Sankyo’s DXd ADC Technology.

The approval by the U.S. Food and Drug Administration (FDA) was based on results from the TROPIONBreast01 phase 3 trial. In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. Two (0.5%) complete responses (CR) and 131 (36%) partial responses (PR) were observed in the DATROWAY arm compared to zero CR and 84 PR (23%) in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 (95% CI: 4.9-6.8) in the chemotherapy arm.

“Despite considerable progress in the HR positive, HER2 negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy,” said Aditya Bardia, MD, MPH, Program Director of Breast Oncology and Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center and Global Principal Investigator for TROPION-Breast01.

“The approval of datopotamab 2 deruxtecan, a novel TROP2 directed antibody drug conjugate, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.” “Only one in three patients with metastatic HR positive, HER2 negative breast cancer live more than five years following diagnosis, highlighting the urgent need for additional effective therapies,” said Caitlin Lewis, Senior Vice President of Strategy & Mission, Living Beyond Breast Cancer. “The approval of DATROWAY is a significant advance, offering patients with metastatic HR positive breast cancer a new and much needed treatment option.”

In TROPION-Breast01, the safety of DATROWAY (6 mg/kg) was evaluated in 360 patients.

“The approval of DATROWAY provides patients with HR positive, HER2 negative breast cancer previously treated with endocrine-based therapy and traditional chemotherapy with the opportunity to be treated with a new TROP2 directed antibody drug conjugate earlier in the metastatic setting,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.

“DATROWAY is the latest addition to our portfolio of innovative cancer treatments and marks the fourth medicine from our oncology pipeline to receive approval in the U.S.” “With this first approval of DATROWAY in the U.S., we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca.

“We are proud to bring DATROWAY to people living with metastatic HR positive, HER2 negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.”