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Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Shots:

  • The CHMP has recommended Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, HR+/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, improved PFS (1EP) by 57% (mPFS: 15 vs 7.3mos.), with consistent benefit across subgroups; a meaningful OS benefit was observed, with full OS data to be shared 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:  Roche| Image:  Roche| Press Release

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