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Roche

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Shots:The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…

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Roche

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Shots:   The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…

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