Datopotamab deruxtecan extends PFS in advanced breast cancer
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Datopotamab deruxtecan significantly improved PFS compared with chemotherapy in patients with previously treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer, according to the agent’s manufacturers.
OS data remained immature as of an interim analysis of results from the randomized phase 3 TROPION-Breast01 trial.
The manufacturers reported no new safety signals associated with use of datopotamab deruxtecan (AstraZeneca, Daiichi Sankyo) and a safety profile similar to results seen in previous trials evaluating the agent for treatment of breast cancer. They additionally noted low rates of all-grade interstitial lung disease observed thus far during the trial.
Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate. In addition to two phase 3 studies in triple-negative breast cancer (TROPION-Breast02 and TROPION-Breast03), the agent is also being evaluated for advanced non-small cell lung cancer as part of the randomized phase 3 TROPION-Lung01 trial, where it demonstrated the ability to extend PFS compared with chemotherapy.
“The positive topline results from TROPION-Breast01 demonstrate the potential for datopotamab deruxtecan to become an important treatment option for patients with [hormone receptor]-positive, HER2-low or HER2-negative breast cancer in the second-line metastatic setting,” Ken Takeshita, MD, global head of oncology R&D with Daiichi Sankyo, said in a company-issued press release. “We look forward to realizing the full potential of this TROP2-directed antibody-drug conjugate across breast cancer subtypes through our ongoing phase 3 program.”
The multicenter phase 3 TROPION-Breast01 trial evaluated the safety and efficacy of datopotamab deruxtecan versus an investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in more than 700 adults with inoperable or metastatic hormone receptor-positive, HER2-low or HER2-negative breast cancer who have experienced disease progression while receiving endocrine-based therapy. The study also includes those deemed ineligible for endocrine-based therapy.
PFS determined by independent central review committee and OS served as dual primary endpoints for the open-label study. Key secondary endpoints included objective response rate, duration of response, investigator-assessed PFS, disease control rate and time to first subsequent therapy.
Complete data from TROPION-Breast01 trial will be presented at an upcoming medical meeting and shared with regulatory authorities, according to the release.
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