RE:RE:RE:RE:RE:RE: Pelareorep + Paclitaxel = ADC/HER2 failed breast cancerMay 29, 2024 - Roche/Genentech's priority review for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant was evaluated in adult patients with P1K3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer,is based on the positive Phase III INAVO120 results.
The results showed the inavolisib-based regimen more than doubled progression-free survival (PFS), reducing the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001) in the first-line setting.
Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 [boundary of 0.0098]). Follow-up for OS is continuing to the next analysis.
https://www.biospace.com/article/releases/fda-grants-priority-review-to-genentech-s-inavolisib-for-advanced-hormone-receptor-positive-her2-negative-breast-cancer-with-a-pik3ca-mutation/