Japanese journal of clinical oncology · 2026
Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Shimomura Akihiko, Kogawa Takahiro, Matsumoto Koji, Watanabe Junichiro, Watanabe Kenichi, Nakayama Takahiro, Shien Tadahiko, Iwasa Tsutomu, Padman Sunita, Huynh Danh, Shao Jiang, Kwan Joyce, Iwahori Yuki, Naito Yoichi, Iwata Hiroji
Аннотация
BACKGROUND: Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved outside Japan for previously treated hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) unresectable locally advanced or metastatic BC (mBC) based on the global, phase III TROPiCS-02 study. ASCENT-J02 (NCT05101096; jRCT2031210346), an open-label, phase I/II study, evaluated efficacy and safety of SG in Japanese participants with advanced solid tumors. We report phase II HR+/HER2- mBC cohort primary results.
METHODS: Participants with previously treated HR+/HER2- mBC received SG 10 mg/kg intravenously on days 1 and 8, every 21 days until progression/unacceptable toxicity. Primary endpoint: confirmed independent review committee (IRC)-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), with 10% threshold (H0: ORR ≤10% vs H1: ORR >10%; one-sided P < .025). Key secondary endpoints: investigator-assessed ORR, IRC and investigator-assessed progression-free survival (PFS), overall survival (OS), safety.
RESULTS: Forty-two participants received SG. At the 7.5-month median follow-up, ORR (95% CI) was 16.7% (7.0-31.4; P = .1214) by IRC and 28.6% (15.7-44.6) by investigator. Median PFS (95% CI) was 4.4 months (2.7-8.5) by IRC and 5.6 months (3.3-7.1) by investigator. Median OS (95% CI) was 13.0 months (11.0-not reached). Treatment-emergent adverse events (TEAEs) occurred in 41 (98%) participants (grade ≥ 3, 35 [83%]). No TEAE-related deaths reported; one participant discontinued treatment due to neutropenia.
CONCLUSIONS: Although the primary endpoint (ORR by IRC) was not met (P > .025), overall efficacy results were generally similar to TROPiCS-02, supporting access to SG in Japanese patients with HR+/HER2- mBC. Safety was consistent with the known and manageable SG safety profile.
METHODS: Participants with previously treated HR+/HER2- mBC received SG 10 mg/kg intravenously on days 1 and 8, every 21 days until progression/unacceptable toxicity. Primary endpoint: confirmed independent review committee (IRC)-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), with 10% threshold (H0: ORR ≤10% vs H1: ORR >10%; one-sided P < .025). Key secondary endpoints: investigator-assessed ORR, IRC and investigator-assessed progression-free survival (PFS), overall survival (OS), safety.
RESULTS: Forty-two participants received SG. At the 7.5-month median follow-up, ORR (95% CI) was 16.7% (7.0-31.4; P = .1214) by IRC and 28.6% (15.7-44.6) by investigator. Median PFS (95% CI) was 4.4 months (2.7-8.5) by IRC and 5.6 months (3.3-7.1) by investigator. Median OS (95% CI) was 13.0 months (11.0-not reached). Treatment-emergent adverse events (TEAEs) occurred in 41 (98%) participants (grade ≥ 3, 35 [83%]). No TEAE-related deaths reported; one participant discontinued treatment due to neutropenia.
CONCLUSIONS: Although the primary endpoint (ORR by IRC) was not met (P > .025), overall efficacy results were generally similar to TROPiCS-02, supporting access to SG in Japanese patients with HR+/HER2- mBC. Safety was consistent with the known and manageable SG safety profile.