Oncology News Central (ONC)FDA Approves Inavolisib Combination for Advanced Breast Cancer

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The FDA’s approval of inavolisib (Itovebi) in combination with palbociclib and fulvestrant marks a significant advancement in treating advanced breast cancer. This new regimen targets PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer in patients who have experienced recurrence during or after adjuvant endocrine therapy. The approval is based on the INAVO120 phase 3 clinical trial, which demonstrated substantial improvements in progression-free survival and objective response rates compared to placebo.

Key Points:

• Approval: Inavolisib combination approved for endocrine-resistant, PIK3CA-mutated, HR+, HER2- advanced or metastatic breast cancer.
• Trial Design: INAVO120 study included 325 adults with disease progression during or within 12 months of adjuvant endocrine therapy.
• Efficacy: Median PFS was 15.0 months for inavolisib group vs. 7.3 months for placebo group (HR, 0.43; P<.0001).
• Response Rates: ORR was 58% in the inavolisib group compared to 25% in the placebo group.
• Safety Profile: Common adverse reactions included decreased blood cell counts, increased glucose, stomatitis, diarrhea, and fatigue.
• Dosage: Recommended dose is 9 mg once daily, with or without food, until disease progression or unacceptable toxicity.
• Companion Diagnostic: FoundationOne Liquid CDx assay approved to identify eligible patients.

“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target. The [inavolisib]-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.”
– Komal Jhaveri, MD, Memorial Sloan Kettering Cancer Center in New York City and principal investigator of the study

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