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Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer.

Komal L Jhaveri1,2, Seock-Ah Im3, Cristina Saura4

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Inavolisib combined with palbociclib-fulvestrant significantly improved overall survival in patients with PIK3CA-mutated breast cancer. This combination therapy demonstrated a notable survival benefit compared to placebo, despite increased side effects like hyperglycemia and stomatitis.

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Area of Science:

  • Oncology
  • Clinical Pharmacology

Background:

  • The INAVO120 trial investigated inavolisib plus palbociclib-fulvestrant in PIK3CA-mutated, HR+, HER2- advanced or metastatic breast cancer patients with prior endocrine therapy relapse.
  • Previous findings showed a progression-free survival benefit with this combination therapy.

Purpose of the Study:

  • To report the final overall survival (OS) analysis of the INAVO120 phase 3 trial.
  • To provide updated efficacy and safety data for inavolisib plus palbociclib-fulvestrant.

Main Methods:

  • Randomized, double-blind, placebo-controlled trial involving 325 patients with PIK3CA-mutated, HR+, HER2- advanced or metastatic breast cancer.
  • Patients received either inavolisib plus palbociclib-fulvestrant or placebo plus palbociclib-fulvestrant.

Main Results:

  • Median OS was 34.0 months with inavolisib vs. 27.0 months with placebo (HR=0.67, P=0.02), indicating a significant survival benefit.
  • Objective response rates were 62.7% for inavolisib and 28.0% for placebo (P<0.001).
  • Higher incidences of hyperglycemia, stomatitis, gastrointestinal, and ocular toxicities were observed with inavolisib.

Conclusions:

  • Inavolisib plus palbociclib-fulvestrant significantly improves overall survival in patients with PIK3CA-mutated advanced or metastatic breast cancer.
  • The observed survival benefit must be weighed against an increased risk of specific adverse events, including hyperglycemia and stomatitis.