The U.S. Food and Drug Administration (FDA) has approved Genentech’s Itovebi (inavolisib) for the treatment of advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a PIK3CA mutation. Itovebi is to be used in combination with palbociclib (Ibrance) and fulvestrant.
This approval is based on results from the Phase III INAVO120 study, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. The median progression-free survival was 15.0 months for the Itovebi-based regimen versus 7.3 months for the control group.
Dr. Komal Jhaveri, section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study, stated: “The PI3K pathway plays a pivotal role in disease progression and has been challenging to target. The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated.”
The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers. This approval addresses an urgent unmet need for patients with this mutation, which is associated with poor prognosis.
Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development, commented: “With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation.”
Jean Sachs, CEO of Living Beyond Breast Cancer, emphasized the importance of comprehensive biomarker testing: “It remains critical that all patients have access to early, comprehensive biomarker testing so they can better understand what treatment options may be most beneficial for them and their tumor type.”
Itovebi will be available in the U.S. in the coming weeks. The drug is currently being investigated in various combinations across three company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer.
