Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study - PubMed
6 hours ago
- #clinical trial
- #antibody-drug conjugate
- #breast cancer
- Sacituzumab govitecan (SG) was studied in Japanese patients with HR+/HER2- metastatic breast cancer in the ASCENT-J02 phase II trial.
- The primary endpoint of objective response rate (ORR) by independent review was 16.7%, not meeting the statistical threshold (P = .1214), but investigator-assessed ORR was 28.6%.
- Median progression-free survival was 4.4 months (IRC-assessed) and 5.6 months (investigator-assessed), with median overall survival of 13.0 months.
- Treatment-emergent adverse events occurred in 98% of participants, with 83% being grade ≥3, consistent with the known safety profile of SG.
- Efficacy results were generally similar to the global TROPiCS-02 study, supporting access to SG for Japanese patients with this cancer type.