The addition of inavolisib (Itovebi) to palbociclib
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
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