European Commission Approves Roche's Itovebi for Breast Cancer Treatment with PIK3CA Mutation

Roche has received EU approval for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for locally advanced or metastatic ER-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval is based on a Phase III trial showing a 57% reduction in progression or death risk and a 33% overall survival benefit. The combination also delays chemotherapy by approximately two years. Additional Phase III trials are ongoing to expand Itovebi's indications.

Roche has received European Commission approval for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for the treatment of locally advanced or metastatic ER-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval is based on a Phase III trial, INAVO120, which demonstrated a 57% reduction in progression or death risk and a 33% overall survival benefit. The combination also delayed chemotherapy by approximately two years, offering significant clinical and commercial advantages.

The INAVO120 trial enrolled 325 patients and compared Itovebi plus palbociclib and fulvestrant against placebo plus palbociclib and fulvestrant. The primary endpoint of progression-free survival (PFS) showed a median improvement from 7.3 to 15.0 months, while overall survival (OS) improved from 27.0 to 34.0 months. These results, published in the New England Journal of Medicine in October 2024, underscore the clinical significance of Itovebi in this patient population.

Itovebi's unique mechanism of targeting the PI3K alpha isoform with high specificity and facilitating the degradation of mutated PI3K alpha sets it apart from existing therapies like Alpelisib (Piqray). The drug's well-tolerated profile, with minimal new safety signals and low discontinuation rates, further enhances its appeal for long-term adherence in chronic diseases like advanced breast cancer.

Beyond the initial indication, Roche is conducting three additional Phase III trials (INAVO121, INAVO122, INAVO123) to expand Itovebi's use across different breast cancer subtypes and treatment lines. These trials aim to further solidify Roche's position in precision oncology, a sector projected to grow at a 15% CAGR through 2030.

The EU approval of Itovebi unlocks access to a $2 billion market for PIK3CA-mutated breast cancer, with potential expansion into other indications. Analysts estimate peak sales of $3 billion by 2028, driven by Itovebi's first-mover advantage and superior efficacy. For investors, the combination of robust clinical evidence, a well-positioned pipeline, and Roche's R&D prowess presents a high-conviction buy opportunity.

References:
[1] https://www.ainvest.com/news/roche-itovebi-game-changer-targeted-breast-cancer-therapy-high-conviction-buy-2025-2026-2507/
[2] https://finance.yahoo.com/news/european-commission-approves-roche-itovebi-050000826.html