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Key clinical point: Enobosarm, a selective androgen receptor modulator, showed antitumor activity and an acceptable safety profile in pretreated women with estrogen receptor-positive (ER+), androgen receptor-positive (AR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: The clinical benefit rate was ~30% at 24 weeks, with 32% and 29% of patients showing clinical benefits with 9 mg and 18 mg enobosarm, respectively. Grades 3-4 treatment-related adverse events were reported by 8% and 16% of patients in the 9 mg and 18 mg enobosarm groups, respectively.
Study details: Findings are from a phase 2 study that included 136 pretreated postmenopausal women with ER+/HER2− locally advanced or metastatic BC who were randomly assigned to receive 9 mg or 18 mg enobosarm daily, of whom 102 women had AR+ BC.
Disclosures: This study was funded by GTx. Several authors declared receiving grants or honoraria from; serving in consulting, leadership, or advisory roles for; owning patents with or stocks of; or having other ties with various sources, including GTx.
Source: Palmieri C, Linden H, Birrell SN, et al. Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): A randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. Lancet Oncol. 2024;25(3):317-325 (Feb 8). doi: 10.1016/S1470-2045(24)00004-4 Source
Key clinical point: Enobosarm, a selective androgen receptor modulator, showed antitumor activity and an acceptable safety profile in pretreated women with estrogen receptor-positive (ER+), androgen receptor-positive (AR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: The clinical benefit rate was ~30% at 24 weeks, with 32% and 29% of patients showing clinical benefits with 9 mg and 18 mg enobosarm, respectively. Grades 3-4 treatment-related adverse events were reported by 8% and 16% of patients in the 9 mg and 18 mg enobosarm groups, respectively.
Study details: Findings are from a phase 2 study that included 136 pretreated postmenopausal women with ER+/HER2− locally advanced or metastatic BC who were randomly assigned to receive 9 mg or 18 mg enobosarm daily, of whom 102 women had AR+ BC.
Disclosures: This study was funded by GTx. Several authors declared receiving grants or honoraria from; serving in consulting, leadership, or advisory roles for; owning patents with or stocks of; or having other ties with various sources, including GTx.
Source: Palmieri C, Linden H, Birrell SN, et al. Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): A randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. Lancet Oncol. 2024;25(3):317-325 (Feb 8). doi: 10.1016/S1470-2045(24)00004-4 Source
Key clinical point: Enobosarm, a selective androgen receptor modulator, showed antitumor activity and an acceptable safety profile in pretreated women with estrogen receptor-positive (ER+), androgen receptor-positive (AR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: The clinical benefit rate was ~30% at 24 weeks, with 32% and 29% of patients showing clinical benefits with 9 mg and 18 mg enobosarm, respectively. Grades 3-4 treatment-related adverse events were reported by 8% and 16% of patients in the 9 mg and 18 mg enobosarm groups, respectively.
Study details: Findings are from a phase 2 study that included 136 pretreated postmenopausal women with ER+/HER2− locally advanced or metastatic BC who were randomly assigned to receive 9 mg or 18 mg enobosarm daily, of whom 102 women had AR+ BC.
Disclosures: This study was funded by GTx. Several authors declared receiving grants or honoraria from; serving in consulting, leadership, or advisory roles for; owning patents with or stocks of; or having other ties with various sources, including GTx.
Source: Palmieri C, Linden H, Birrell SN, et al. Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): A randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. Lancet Oncol. 2024;25(3):317-325 (Feb 8). doi: 10.1016/S1470-2045(24)00004-4 Source