Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-re

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INAVO120 trial showed improved progression-free/overall survival with inavolisib plus palbociclib-fulvestrant versus placebo in PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced breast cancer.
Key selected adverse events analyzed included hyperglycemia, rash, stomatitis/mucosal inflammation, and diarrhea, with management via dose modifications and concomitant medications.
Hyperglycemia led to inavolisib dose interruptions in 27.2% of patients, reductions in 2.5%, and discontinuations in 0.6%; median time to first onset was 7 days, managed primarily with metformin.
Rash resulted in inavolisib dose interruptions in 1.2% and reductions in 0.6%, with no discontinuations; median time to onset was 29 days, treated mainly with topical hydrocortisone.
Stomatitis/mucosal inflammation caused inavolisib dose interruptions in 9.9%, reductions in 3.7%, and discontinuations in 0.6%; median onset time was 13 days, commonly managed with dexamethasone mouthwash.
Diarrhea led to inavolisib dose interruptions in 6.8% and reductions in 1.2%, with no discontinuations; median onset time was 13 days, with loperamide as the most used treatment.
Safety profile of inavolisib was consistent across regions and ages, deemed manageable, tolerable, and generally reversible with supportive therapies.

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