Roche announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutate locally advanced or metastatic breast Cancer in various combinations. The INAVO120 study [NCT04191499] is a Phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib in combination with palbocIClib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-Mutated, hormone receptor (HR)-positive, human epidermalgrowth factor receptor 2 (HER2)-negative, locally advanced or metast metastatic breast cancer whose disease progressed during treatment or within 12 months of completed adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.

Beyond INAVO120, inavolisib is currently being investigate in two additional company-sponsored Phase III clinical study in PIK3CA- mutual disease in various combinations: in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trASTuzumab for SC and optional physician-based treatment.