Tahubulat although OS data were immature at the time

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Discontinuation of trial enrollment due to an invasive disease event or death occurred in 105 patients (14.1%) in the T-DM1 group and 159 patients (21.4%) in the trastuzumab group. Additionally, prior discontinuation occurred in 117 patients (15.7%) and 123 patients (16.6%), respectively.

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).

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