Itovebi – BiotechReality – Information Intelligence System for Biopharma

New evidence shows that Roche's Itovebi regimen dramatically improves survival for patients with a certain form of HR-positive advanced breast cancer, a hopeful advance in the treatment of this difficult-to-treat disease. The results, released by Roche, showed that Itovebi, when used together, lowered the risk of death by more than 30% in patients with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer compared to the control arm of palbociclib and fulvestrant alone. The mutation in the PIK3CA gene, found in about 40% of HR-positive advanced breast cancers, is usually associated with a worse prognosis. For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer, Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed. Levi Garraway, M.D., Ph.D The Itovebi-based therapy showed a significant overall survival (OS) advantage. Patients in the Itovebi cohort achieved a median OS of 34.0 months, a significant improvement compared to the 27.0 months seen in the palbociclib and fulvestrant arm. Also, the revised analysis proved that the advantage in slowing cancer progression was sustained. The Itovebi regimen consistently improved median progression-free survival to 17.2 months from 7.3 months for the comparator arm. Apart from these main findings, the Itovebi-based regimen also caused a statistically significant increase in objective response rate and significantly delayed chemotherapy use by about two years. Itovebi is approved in a number of countries now, among which are the United States, Switzerland, Canada, Australia, the United Arab Emirates, and China. Information from the INAVO120 study, upon which these most recent findings are based, is now being considered for review by other international health authorities. Roche is further pursuing Itovebi's potential in three ongoing company-funded Phase III trials (INAVO121, INAVO122, and INAVO123). The trials are investigating Itovebi across several combinations for PIK3CA-mutated, locally advanced or metastatic breast cancer, demonstrating Roche's ongoing dedication to improving cancer treatment. About Itovebi TM People with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer who frequently have a poor prognosis and urgently need new treatment options can benefit from itovebi, an oral, targeted treatment that has been demonstrated to provide well-tolerated and long-lasting disease control. Because of its high potency and specificity for the PI3K alpha isoform compared to other isoforms, as well as its distinct mechanism of action that promotes the degradation of mutated PI3K alpha, itovebi stands out from other PI3K inhibitors and was developed to help reduce the overall burden and toxicity of treatment. Source: Hoffmann-La Roche Last Modified:

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Roche’s Itovebi Shows Significant Survival Benefit in HR-positive Advanced Breast Cancer

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