Itavebi Approved for Advanced HER2-Negative Breast Cancer with PIK3CA Mutation
european Commission Approves Itavebi for Advanced Breast Cancer, Offering New Hope for PIK3CA-Mutated Patients
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Madrid, spain - July 22, 2024 – The European Commission has granted approval for itavebi (inavolisib), in combination with Palbociclib (Ibrance) and Fulvestrant, marking a significant advancement in the treatment of adult patients diagnosed with locally advanced or metastatic breast cancer. this groundbreaking therapy targets a specific genetic mutation, PIK3CA, in patients whose tumors are estrogen receptor (ER) positive and HER2 negative, particularly those who have experienced relapse during or within 12 months of completing adjuvant endocrine therapy.
A new era in Targeted Breast Cancer Treatment
The approval of Itavebi represents a pivotal moment in the fight against a challenging subtype of breast cancer. “Itavebi is the first treatment of its class that has demonstrated a statistically significant impact on the overall survival of those who suffer from advanced breast cancer with PIK3CA mutation and ER positive,” stated levi Garraway, Roche’s Chief Medical Officer and Head of Global Development.”Therefore,the regimen based on this medicine can help address an vital unmet medical need for people with this subtype of breast cancer.”
This sentiment is echoed by Eva Ciruelos,Coordinator of the Breast Cancer Unit at the 12 de Octubre hospital in Madrid and vice President of SOLTI.”This new inhibitor, more selective of this enzyme, provides a benefit not only in progression-free survival but also in overall survival in these patients, when they relapse during adjuvant hormonal treatment,” Ciruelos explained. “In addition, it offers a considerably better tolerance profile, with fewer side effects and lower rates of hyperglycemia compared to older inhibitors.”
Clinical Trial Success Drives Approval
The European Commission’s decision is underpinned by the robust results of the Phase III ’Inavo120′ trial. Published in the prestigious New England Journal of medicine in october 2024, the study revealed that the Itavebi-based regimen reduced the risk of disease progression or death (progression-free survival, PFS) by a remarkable 57% compared to palbociclib and Fulvestrant alone in the first-line setting.
The PFS benefit was consistent across all patient subgroups, and the Itavebi regimen was well-tolerated, with no new safety concerns identified.These findings were further strengthened by the final overall survival analysis of ‘Inavo120’. This analysis demonstrated that the Itavebi regimen reduced the risk of death by 33%.Moreover, the treatment regimen substantially delayed the need for chemotherapy by approximately two years when compared to Palbociclib and Fulvestrant used as monotherapy. These pivotal data were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO 2025) and subsequently published in the New England Journal of Medicine in May of this year, solidifying the efficacy and safety profile of Itavebi.
Ongoing Research and global Reach
Beyond the ‘Inavo120’ trial, Itavebi is currently under investigation in three additional Phase III studies sponsored by Roche: ‘Inavo121’, ‘Inavo122’, and ‘Inavo123’. These studies are exploring Itavebi in various combinations for patients with locally advanced or metastatic breast cancer harboring PIK3CA mutations.
The Itavebi regimen has already received approval for the treatment of adults with locally advanced or metastatic breast cancer resistant to endocrine treatments, with PIK3CA mutations, ER-positive, and HER2-negative status, in several key markets including the United States, Switzerland, Canada, Australia, the United Arab Emirates, China, and taiwan. Data from the ’Inavo120′ trial are currently under review by other global health authorities,signaling a potential for broader access to this life-changing therapy.