INAVO120 Final Analysis: Translating Overall Survival Data into Clinical Practice

Video content above is prompted by the following:

This comprehensive clinical Insights program features leading breast medical oncologists Julia Foldi, MD, PhD, Elisa Krill-Jackson, MD, and Timothy J. Pluard, MD discussing the evolving landscape of hormone receptor positive, HER2 negative metastatic breast cancer treatment. The panel explores how biomarker-driven approaches are revolutionizing therapy selection and sequencing strategies, with particular emphasis on precision medicine applications in endocrine-resistant disease. Their discussion centers on translating recent clinical trial data into practical treatment paradigms for oncologists managing this patient population.

The INAVO120 trial, recently presented at the ASCO annual meeting, demonstrated remarkable efficacy outcomes for patients with PIK3CA-mutated endocrine resistant disease. The study compared inavolisib plus palbociclib plus fulvestrant versus placebo plus palbociclib plus fulvestrant, showing significant improvements in both progression-free survival and overall response rates. The final overall survival analysis revealed a median overall survival of 34 months in the inavolisib group compared to 27 months in the placebo group, representing a clinically meaningful 7-month improvement. These statistically significant benefits were consistently observed across all patient subgroups, establishing inavolisib as a promising therapeutic option for this challenging patient population.

Dr. Krill emphasizes that while the INAVO120 results are encouraging, with inavolisib representing one of the more tolerable PIK3CA inhibitors available, the trial design presents interpretation challenges for clinical practice. Notably, less than 10% of patients crossed over to receive a PIK3CA inhibitor after progression, confirming the overall survival benefit of this drug class but not necessarily supporting first-line use exclusively. The observation that most placebo-arm patients progressed directly to chemotherapy highlights a critical clinical consideration: patients may not have subsequent opportunities for PIK3CA inhibitor therapy if not administered in earlier treatment lines, making optimal sequencing decisions crucial for maximizing patient outcomes.