Roche’s inavolisib meets primary endpoint of PFS in Phase 3 breast cancer trial

Roche, a global leader in pharmaceuticals, announced positive results from its Phase III INAVO120 study, testing the investigational therapy inavolisib in combination with palbociclib (Ibrance) and fulvestrant. This study targeted patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The trial met its primary endpoint, showing a significant improvement in progression-free survival (PFS) compared to the control group.

Transformative Potential for Breast Cancer Treatment

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, highlighted the potential impact of these results. He emphasized the transformative nature of the inavolisib combination for patients with PIK3CA-mutated HR-positive breast cancer. Garraway expressed Roche’s commitment to expanding its breast cancer medicine portfolio and rapidly bringing this new treatment option to patients.

Study Design and Efficacy

The INAVO120 study was a randomized, double-blind, placebo-controlled trial involving 325 patients. It evaluated the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant. The primary endpoint was progression-free survival, and secondary endpoints included overall survival, objective response rate, and clinical benefit rate. The inavolisib combination was well tolerated, with adverse events aligning with the known safety profiles of the individual treatments.

Inavolisib: A Novel Approach to Breast Cancer

Inavolisib, an investigational oral therapy, stands out for its high potency and selectivity for PI3Kα inhibition, especially in targeting the mutant PI3Kα protein. This unique dual mechanism of action positions inavolisib as a potentially improved treatment option for patients with HR-positive/HER2-negative, PIK3CA-mutated advanced breast cancer, a demographic that encompasses approximately 40% of patients. The drug is currently under investigation in three Phase III clinical studies.

Collaborative Research and Development

Roche’s research into inavolisib showcases a commitment to addressing the needs of breast cancer patients with specific genetic mutations. This approach reflects a broader trend in personalized medicine, aiming to tailor treatments to individual patient profiles for better outcomes.