Patent No. EP4294395 (titled "Treatment Of Breast Cancer Using Combination Therapies Comprising Gdc-9545 And Gdc-0077") was filed by Genentech on Feb 14, 2022. The application was issued on Mar 26, 2025.
Combination therapies comprising GDC-9545 (or its pharmaceutically acceptable salts) and GDC-0077 are provided for treating estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced breast cancer (laBC) or metastatic breast cancer (mBC). Treatment methods include administering both agents once daily (QD) on days 1–28 of one or more 28-day cycles, specifically in regimens of 30 mg GDC-9545 and 9 mg GDC-0077 for 2 to 72 cycles. These therapies aim to inhibit tumor growth, produce tumor regression, and increase overall survival, progression-free survival, and clinical benefit rates compared to controls, while potentially reducing adverse events like hepatotoxicity and hyperglycemia. Patients may be screened for ER, PR, Ki67, or PIK3CA mutations.

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