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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, June 27, 2024
More results of the randomized phase III INAVO120 trial indicate the benefit of an inavolisib-based regimen in patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have relapsed during or within 12 months of adjuvant endocrine therapy completion and who have not received prior systemic therapy for metastatic disease. According to Dejan Juric, MD, of Massachusetts General Hospital Cancer Center, Boston, and colleagues, who presented their results during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 1003), the PI3K inhibitor inavoliosib plus the CDK4/6 inhibitor palbociclib, and the hormone therapy fulvestrant may represent a new standard of care for this patient population.
One efficacy endpoint was the time from randomization to the end of next-line treatment, which was a proxy for second progression-free survival, and another was time from randomization to first chemotherapy. With a median follow-up of 21.3 months, increases in median “second progression-free survival” were 24.0 vs 15.1 months in the placebo arm (unstratified hazard ratio [HR] = 0.59) and increases in the time to first chemotherapy were not evaluable vs 15.0 months (unstratified HR = 0.53).
Regarding the key adverse events associated with inavolisib—hyperglycemia, diarrhea, rash, and stomatitis—most were grade 1 or 2 (none were grade 4 or 5), and most had resolved, the authors stated. The events were “managed with standard supportive care and inavolisib dose interruptions/reductions,” according to the investigators.
To assess patient-reported outcomes, the investigators used standard questionnaires and an overall bother item. Dr. Juric and co-investigators concluded: “Patients receiving inavolisib (vs placebo) experienced a longer duration of time without worsening pain severity and maintained their day-to-day functioning and health-related quality of life on treatment.”
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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