FDA approves Itovebi regimen for advanced breast cancer
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The FDA approved inavolisib as part of combination therapy for certain adults with breast cancer.
The indication applies to use of inavolisib (Itovebi, Genentech) with palbociclib (Ibrance, Pfizer) and fulvestrant for treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer whose disease recurred on or after adjuvant endocrine therapy.
The agency based approval on results of the randomized phase 3 INAVO120 trial, which included 325 patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during or within 12 months of adjuvant endocrine therapy.
Trial participants had not received prior systemic therapy for locally advanced or metastatic disease.
Researchers randomly assigned patients 1:1 to 9 mg oral inavolisib or placebo once daily, plus 125 mg oral palbociclib, for 21 straight days, followed by 7 days off. Patients also received 500 mg fulvestrant administered intramuscularly on days 1 and 15 of the first 28-day cycle, followed by day 1 of every subsequent cycle.
Treatment continued until disease progression or unacceptable toxicity.
Investigator-assessed PFS served as the major efficacy outcome. Other efficacy outcomes included OS, investigator-assessed objective response rate and duration of response.
Results showed longer median PFS (15 months vs. 7.3 months; HR = 0.43; 95% CI, 0.32-0.59) a higher ORR (58% vs. 25%) and longer median duration of response (18.4 months vs. 9.6 months) among patients assigned inavolisib.
An interim OS analysis showed a numerical advantage with inavolisib but it did not reach statistical significance (HR = 0.64; 95% CI, 0.43-0.97).
The most common adverse events included decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, diarrhea, stomatitis, fatigue, decreased calcium, increased creatinine, decreased potassium, increased alanine aminotransferase, decreased sodium, nausea, rash, decreased magnesium, COVID-19 infection, decreased appetite and headache.
The FDA also approved the FoundationOne Liquid CDx assay (Foundation Medicine) as a companion diagnostic device to identify patients with breast cancer who may benefit from treatment with this regimen.
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