Datroway (datopotamab deruxtecan) approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer – Daiichi Sankyo

Datroway (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting.

The approval of Datroway by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast01 phase III 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. There were two (0.5%) complete responses (CRs) and 131 partial responses (PRs) (36%) seen in the Datroway arm compared to zero (0%) CRs and 84 (23%) PRs 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 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (HR 1.01; 95% CI: 0.83-1.22). In an exploratory sensitivity analysis,

OS adjusted for subsequent ADC treatment was 19.1 months in the Datroway arm versus 17.5 months in the chemotherapy arm (HR 0.86; 95% CI: 0.70-1.06). In an exploratory analysis of the 83 patients enrolled in TROPION-Breast01 in China, median PFS was 8.1 months in patients treated with Datroway versus 4.2 months with chemotherapy (HR 0.54; 95% CI: 0.30-0.96) and a confirmed ORR of 38.6% was observed in the Datroway arm compared to an ORR of 17.9% in the chemotherapy arm.

The approval of DATROWAY provides a new treatment option for patients with metastatic HR positive, HER2 negative breast cancer, enabling timely access to an innovative TROP2 targeted antibody drug conjugate in China,” said Michio Hayashi, China President, Daiichi Sankyo. “DATROWAY is now the second DXd antibody drug conjugate approved in China following ENHERTU and expands our portfolio to meet the evolving treatment needs of patients with a range of breast cancer subtypes.”

“Despite considerable advancements in the treatment of HR positive breast cancer, new medicines are still needed to tackle the frequent and complex challenge of disease progression following initial therapies,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “We are proud to bring DATROWAY to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option.

“Despite the progress we have made in managing HR positive, HER2 negative metastatic breast cancer, many patients still face limited options once their disease progresses after endocrine therapy and chemotherapy,” said Prof. Binghe Xu, Director of Clinical Trial Center (GCP) of National Cancer Center, Cancer Hospital Chinese Academy of Medical Sciences, and China leading PI of TROPION-Breast01. “The approval of datopotamab deruxtecan, a novel TROP2 directed antibody drug conjugate, represents a meaningful step forward in expanding therapeutic choices for patients with breast cancer.”

TROPION-Breast01 is a global, randomized, multicenter, open-label phase III trial (NCT05104866) evaluating the efficacy and safety of intravenous Datroway (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

See- Bardia A, Jhaveri K, Im SA, Pernas S et al. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01. J Clin Oncol 2024 43, 285 DOI:10.1200/JCO.24.00920