Overall Survival with Inavolisib in PIK3CA -Mutated Advanced Breast Cancer

作者：Komal L. Jhaveri, Seock‐Ah Im, Cristina Saura, Sibylle Loibl, Kevin M. Kalinsky, Peter Schmid, Sherene Loi, Eirini Thanopoulou, Noopur Shankar, Yanling Jin, Thomas J. Stout, Ted Clark, Chunyan Song, Dejan Juric, Nicholas C. Turner · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2501796 · 被引用次数：102 · 研究领域：Advanced Breast Cancer Therapies、PI3K/AKT/mTOR signaling in cancer、HER2/EGFR in Cancer Research

BACKGROUND: -mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had had relapse during or within 12 months after completion of adjuvant endocrine therapy. METHODS: -mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who had had disease recurrence or progression during or within 12 months after completion of adjuvant endocrine therapy to receive inavolisib plus palbociclib-fulvestrant (inavolisib group) or placebo plus palbociclib-fulvestrant (placebo group). In the current report, we provide the results of the final analysis of overall survival, including updated data on efficacy and safety. RESULTS: A total of 161 patients were assigned to the inavolisib group, and 164 to the placebo group. After a median follow-up of 34.2 months in the inavolisib group and 32.3 months in the placebo group, the median overall survival was 34.0 months (95% confidence interval [CI], 28.4 to 44.8) with inavolisib and 27.0 months (95% CI, 22.8 to 38.7) with placebo (hazard ratio for death, 0.67; 95% CI, 0.48 to 0.94; P = 0.02 [prespecified boundary for statistical significance, P<0.0469]). An objective response occurred in 62.7% (95% CI, 54.8 to 70.2) of patients in the inavolisib group and 28.0% (95% CI, 21.3 to 35.6) of those in the placebo group (P<0.001). The updated hazard ratio for disease progression or death was 0.42 (95% CI, 0.32 to 0.55). Adverse events...