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Phase III Study Shows Genentech's Itovebi Combo Cuts Death Risk By 30% In Advanced Breast Cancer

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Genentech, a member of the Roche Group (RHHBY), announced positive final results from the overall survival analysis of the Phase III INAVO120 study. These data showed Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer.

The Itovebi-based regimen demonstrated a meaningful overall survival benefit compared with palbociclib and fulvestrant alone. The median overall survival was 34.0 months for people in the Itovebi arm, compared with 27.0 months in the palbociclib and fulvestrant arm. The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months in the comparator arm.

The company noted that Itovebi-based regimen also led to a statistically significant improvement in objective response rate and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years. No new safety signals were observed at the time of the final overall survival analysis, with a low discontinuation due to adverse events supporting good tolerability.

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