Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This approval makes inavolisib the first third-generation PI3Kα inhibitor to be approved in China.
Clinical Trial Basis
The NMPA’s decision is based on positive results from the INAVO120 study, a randomized, double-blind, placebo-controlled, multicenter trial. The study assessed the efficacy and safety of the inavolisib combination in first-line endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.
Efficacy and Safety Results
In the INAVO120 study, the inavolisib combination group demonstrated significant improvements in progression-free survival (PFS) and response rate. The PFS was 15.0 months versus 7.3 months in the control group, with an objective response rate (ORR) of 58% compared to 25%. The combination reduced the risk of disease progression or death by 57% and was shown to be safe and well-tolerated.-Fineline Info & Tech
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