Study Design
The INAVO120 trial was a randomized, double-blind, placebo-controlled, multicenter study involving 325 patients with endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer. The primary endpoint was investigator-assessed PFS, with a follow-up duration until disease progression or unacceptable toxicity. Patients were randomized 1:1 to receive either inavolisib or placebo, with stratification based on visceral disease presence, type of endocrine resistance, and geographic region. Key limitations include the need for further studies to evaluate long-term outcomes and safety in diverse populations.
What is Inavolisib (Itovebi) approved for?
Inavolisib is approved for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer, as of October 10, 2024, based on the INAVO120 trial showing a median PFS of 15.0 months versus placebo.
How does Inavolisib work?
Inavolisib is a selective inhibitor of the PI3K alpha isoform, which plays a crucial role in cellular signaling pathways that regulate cell growth and survival, particularly in cancer cells.
What is the recommended dose of Inavolisib?
Inavolisib is administered at 9 mg orally once daily, in combination with palbociclib and fulvestrant. Clinicians should consult current prescribing information for full dosing guidance.
What are the most common side effects of Inavolisib?
Common side effects include hyperglycemia, diarrhea, nausea, fatigue, and liver function changes.
How does Inavolisib compare to placebo?
Inavolisib showed a median PFS of 15.0 months compared to 7.3 months with placebo in the INAVO120 trial.
Who qualifies for Inavolisib treatment?
Patients with endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative breast cancer who have progressed during or within 12 months of completing adjuvant endocrine therapy qualify for treatment with Inavolisib.