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<p>In the global CAPItello-291 randomized phase 3 study (NCT04305496) in patients with hormone receptor-positive/HER2-negative advanced breast cancer and progression during/after aromatase inhibitor treatment, capivasertib–fulvestrant significantly improved progression-free survival (PFS) in the overall population and patients with <i>PIK3CA/AKT1/PTEN</i>-altered tumors versus placebo–fulvestrant. We assessed efficacy and safety of capivasertib–fulvestrant in a prespecified exploratory analysis of a Chinese cohort (<i>n</i> = 24) and extended study with the same protocol (<i>n</i> = 110). Clinically meaningful PFS benefit for capivasertib–fulvestrant was observed in the overall population (median PFS: 6.9 [capivasertib–fulvestrant] versus 2.8 [placebo–fulvestrant] months; hazard ratio 0.51, 95% CI 0.34–0.76), patients with <i>PIK3CA/AKT1/PTEN</i>-altered tumors (<i>n</i> = 46; 5.7 versus 1.9 months; hazard ratio 0.41, 95% CI 0.19–0.85) and <i>PIK3CA/AKT1/PTEN</i>-non-altered tumors (patients with confirmed next-generation sequencing results [<i>n</i> = 68]; 9.2 versus 2.7 months; hazard ratio 0.38; 95% CI 0.21–0.68). The most frequent adverse events (AEs) with capivasertib–fulvestrant were diarrhea (60.6% versus 11.3% with placebo–fulvestrant) and hyperglycemia (57.7% versus 17.7%). AEs leading to capivasertib–fulvestrant discontinuation were reported in 11.3% of patients versus 3.2% for placebo–fulvestrant. The benefit-risk profile of capivasertib–fulvestrant in the Chinese cohort was favorable; further exploration in patients with <i>PIK3CA/AKT1/PTEN</i>-non-altered tumors is warranted.</p>

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Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort

  • 期刊论文

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  • 发表日期：

    2025年5月9日

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  • Xichun Hu,
  • Qingyuan Zhang,
  • Tao Sun,
  • Huihua Xiong,
  • Wei Li,
  • Yuee Teng,
  • Yen-Shen Lu,
  • Ling-Ming Tseng,
  • Min Yan,
  • Hongsheng Li,
  • Danmei Pang,
  • Shin-Cheh -Chen,
  • Wenyan Chen,
  • Ou Jiang,
  • Jingfen Wang,
  • Xinhong Wu,
  • Xian Wang,
  • Aimin Zang,
  • Xiaojia Wang,
  • Julie M. Collins,
  • Ethan Fan,
  • Lin Jiang,
  • Xiaoling Zeng,
  • Nicholas C. Turner

摘要

In the global CAPItello-291 randomized phase 3 study (NCT04305496) in patients with hormone receptor-positive/HER2-negative advanced breast cancer and progression during/after aromatase inhibitor treatment, capivasertib–fulvestrant significantly improved progression-free survival (PFS) in the overall population and patients with PIK3CA/AKT1/PTEN-altered tumors versus placebo–fulvestrant. We assessed efficacy and safety of capivasertib–fulvestrant in a prespecified exploratory analysis of a Chinese cohort (n = 24) and extended study with the same protocol (n = 110). Clinically meaningful PFS benefit for capivasertib–fulvestrant was observed in the overall population (median PFS: 6.9 [capivasertib–fulvestrant] versus 2.8 [placebo–fulvestrant] months; hazard ratio 0.51, 95% CI 0.34–0.76), patients with PIK3CA/AKT1/PTEN-altered tumors (n = 46; 5.7 versus 1.9 months; hazard ratio 0.41, 95% CI 0.19–0.85) and PIK3CA/AKT1/PTEN-non-altered tumors (patients with confirmed next-generation sequencing results [n = 68]; 9.2 versus 2.7 months; hazard ratio 0.38; 95% CI 0.21–0.68). The most frequent adverse events (AEs) with capivasertib–fulvestrant were diarrhea (60.6% versus 11.3% with placebo–fulvestrant) and hyperglycemia (57.7% versus 17.7%). AEs leading to capivasertib–fulvestrant discontinuation were reported in 11.3% of patients versus 3.2% for placebo–fulvestrant. The benefit-risk profile of capivasertib–fulvestrant in the Chinese cohort was favorable; further exploration in patients with PIK3CA/AKT1/PTEN-non-altered tumors is warranted.