Datopotamab deruxtecan fails to extend OS vs. chemotherapy in advanced breast cancer
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Datopotamab deruxtecan failed to extend OS vs. chemotherapy for adults with advanced breast cancer, according to the agent’s manufacturer.
Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo) is a TROP2-directed antibody-drug conjugate that has demonstrated antitumor activity among pretreated patients with metastatic hormone receptor-positive, HER2-negative breast cancer.
The randomized phase 3 TROPION-Breast01 trial included 732 adults with inoperable or metastatic hormone receptor-positive, HER2-low or HER2-negative breast cancer. Study participants either experienced disease progression after endocrine-based therapy or had been deemed ineligible for endocrine-based therapy.
All study participants had received one to two prior lines of systemic chemotherapy and had ECOG performance status of 0 or 1.
Researchers randomly assigned 365 patients to datopotamab deruxtecan dosed at 6 mg/kg via IV on day 1 of each 3-week cycle.
The other 367 patients received investigator’s choice of single-agent chemotherapy — eribulin, capecitabine, vinorelbine or gemcitabine.
PFS assessed by blinded independent clinical review and OS served as dual primary endpoints. Key secondary endpoints included objective response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety.
As Healio previously reported, patients assigned datopotamab deruxtecan achieved significantly longer PFS than those assigned chemotherapy.
However, OS did not differ significantly between treatment groups.
Complete data will be presented at a medical meeting.
“The metastatic [hormone receptor]-positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients. Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting,” Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said in a company-issued press release. “We will continue discussions with regulatory authorities and apply insights from these results to our clinical development program for datopotamab deruxtecan in breast cancer.”
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