Inavosilib in PIK3CA-mutated advanced breast cancer

New data from the phase 3 INAVO120 trial, recently published on The New England Journal of Medicine, showed a significant overall survival benefit for inavosilib plus palbociclib-fulvestrant versus placebo plus palbociclib-fulvestrant in PIK3CA-mutated advanced breast cancer.

In patients with PIK3CA– mutated, hormone receptor–positive, HER2–negative locally advanced or metastatic breast cancer who had had relapse during or within 12 months after completion of adjuvant endocrine therapy, INAVO120 trial has shown a significant progression-free survival benefit for inavosilib plus palbociclib-fulvestrant versus placebo plus palbociclib-fulvestrant. In this new paper, authors provide the results of the final analysis of overall survival; after a median follow-up of 34,2 monhts (inavosilib group) or 32,3 months (placebo group), the median overall survival was 34 months with inavosilib and 27 months with placebo. Objective response occurred in 62,7% of inavosilib group and 28% of placebo group. Adverse events led to discontinuation of inavolisib in 6.8% of patients and discontinuation of placebo in 0.6%: hyperglycemia, stomatitis or mucosal inflammation, gastrointestinal toxic effects and ocular toxic effects were more frequent with inavosilib than with placebo. As authors say, «The previously reported improvement in progression-free survival was maintained during the longer follow-up period. Early clinical benefit with inavolisib as well as the higher percentage of patients with an objective response in the inavolisib group than in the placebo group further support the efficacy of this treatment, particularly in patients with disease characteristics indicating a poor prognosis, for whom early and rapid disease control is crucial for attaining better long-term outcomes».