RE: Pelareorep + Paclitaxel = ADC/HER2 failed breast cancerBesides the ADC Enhertu being approved for multiple stages of ER+/Her2 (+/-) (posotove/negative) breast cancer, ONCY's decision to target the HER2 failed breast cancer patient population with pelareorep + paclitaxel may have been also influenced by today's Roche/Genentech's breakthrough therapy announcement involving ER+/Her2- (negative) breast cancer
May 21, 2024 - Genentech, a member of the Roche Group , announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (CDK4/6) (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA -mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
https://www.biospace.com/article/releases/fda-grants-breakthrough-therapy-designation-to-genentech-s-inavolisib-for-advanced-hormone-receptor-positive-her2-negative-breast-cancer-with-a-pik3ca-mutation/