Shots:
- The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial
- Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS (1EP) by 57% (mPFS: 15 vs 7.3mos.) & a 33% reduction in death risk, with consistent PFS benefit across subgroups; regimen delayed also CT by ~2yrs. PFS & OS data was published in The NEJM, with OS data presented at ASCO 2025
- Additionally, Roche is evaluating Itovebi in 3 more P-III trials (INAVO121, INAVO122 & INAVO123) for the same indication in various combinations
Ref: GlobeNewsWire| Image: Roche| Press Release
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