Roche's Itovebi Shows Promising Survival Benefit in Advanced Breast Cancer

Roche's PI3K inhibitor Itovebi has demonstrated significant survival benefits in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, further solidifying its potential as a blockbuster treatment. The latest data from the phase 3 INAVO120 trial, to be presented at the American Society of Clinical Oncology's (ASCO) annual meeting, reveals that Itovebi, when combined with Pfizer's Ibrance and AstraZeneca's Faslodex, reduced the risk of death by 33% compared to placebo.

Impressive Survival Data

The INAVO120 trial, involving 325 patients, showed that the Itovebi triplet combination extended median overall survival to 34 months, compared to 27 months for those receiving placebo with Ibrance and Faslodex. This marks a significant milestone in the PI3KCA-targeting arena, as no previous drug had delivered a statistically significant survival benefit in this patient population.

Dr. Charlie Fuchs, head of oncology and hematology global product development at Roche's Genentech, emphasized the importance of these results, stating that they provide "proof in the pudding" for Itovebi's best-in-class capabilities due to its specificity in targeting.

Updated Progression-Free Survival and Safety Profile

The final overall survival results have allowed Roche to recalculate Itovebi's progression-free survival findings. The updated data shows that Itovebi kept patients alive without disease progression for a median of 17.2 months, compared to the previously reported 15 months. This contrasts sharply with the unchanged 7.3 months observed in the placebo group.

While the efficacy data is promising, the safety profile of Itovebi requires careful consideration. Serious side effects were observed in both treatment groups, with 90.7% of Itovebi patients experiencing grade 3 or 4 adverse events, compared to 84.7% in the placebo arm. Notably, hyperglycemia affected 63.4% of patients in the Itovebi group, versus 13.5% in the placebo group. However, Dr. Fuchs maintains that this safety signal is "manageable," citing data showing that hyperglycemia is not a primary driver of treatment discontinuation.

Market Potential and Future Directions

Given the large market potential for Itovebi, Roche is confident in its blockbuster potential. Teresa Graham, Roche's pharma head, has estimated peak sales at 2 billion Swiss francs ($2.3 billion). In its first full quarter on the market, Itovebi generated sales of 14 million Swiss francs ($16.8 million).

The importance of genomic testing at the time of diagnosis has been highlighted by these results, as emphasized by ASCO breast cancer expert Dr. Jane Lowe Meisel. With HR-positive, HER2-negative breast cancer comprising 70% of breast cancers in the U.S., and about 40% of that population harboring PIK3CA mutations, the potential impact of Itovebi is substantial.

Roche is currently conducting a head-to-head study comparing Itovebi against Novartis' Piqray in the second-line setting for patients with advanced or metastatic breast cancer following CDK4/6-endocrine combination therapy. The results of this study will further clarify Itovebi's position in the treatment landscape for advanced breast cancer.