Boolmunding PIK3CA-mutated breast cancer live pacilingan

The addition of inavolisib (Itovebi) to palbociclib (Ibrance) and fulvestrant (Faslodex) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to palbociclib and fulvestrant alone for patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, which met the key secondary end point of the phase 3 INAVO120 study (NCT04191499).1

These data reinforce the regimen’s efficacy in the frontline, as established by previously reported data from INAVO120. In the primary analysis, patients treated with inavolisib plus palbociclib and fulvestrant achieved a median progression-free survival (PFS) of 15.0 months (95% CI, 11.3-20.5) vs 7.3 months (95% CI, 5.6-9.3) with placebo plus palbociclib and fulvestrant.2This translated to a 57% reduction in the risk of disease worsening or death (HR, 0.43; 95% CI, 0.32-0.59; P < .001).1The overall response rate (ORR) in the experimental arm was 58% (95% CI, 50%-66%) vs 25% (95% CI, 19%-32%) in the placebo arm, and the median duration of response (DOR) was 18.4 months (95% CI, 10.4-22.2) vs 9.6 months (95% CI, 7.4-16.6) in these respective groups.2

Notably, although OS data were immature at the time of the primary analysis, a trend in favor of the inavolisib regimen was observed (HR, 0.64; 95% CI, 0.43-0.97; P = .0338).1

These results supported the FDA approval of inavolisib plus palbociclib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative, advanced or metastatic breast cancer in October 2024.2

“The INAVO120 OS results show that the [inavolisib]-based regimen not only delayed disease progression, but also helped people with advanced hormone receptor–positive, PIK3CA-mutated breast cancer live longer,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, stated in a news release.1 “These findings underscore our ambition to improve survival rates for people with breast cancer. The [inavolisib]-based regimen has the potential to become the new standard of care for these patients.”

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