Saturday, June 15, 2024

FDA Grants Priority Review to Inavolisib for Advanced Breast Cancer

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The U.S. Food and Drug Administration (FDA) has granted Priority Review to inavolisib, an investigational oral therapy developed by Roche. This therapy is to be used in combination with palbociclib (Ibrance®) and fulvestrant for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in patients who have a PIK3CA mutation. The Priority Review status is a significant milestone that highlights the potential of inavolisib to offer substantial improvements in treatment outcomes for patients who are in urgent need of new therapeutic options.

FDA Fast-Tracks Inavolisib for Advanced Breast Cancer

This accelerated review process by the FDA aims to expedite the availability of inavolisib, recognizing its potential to address the critical needs of patients who have limited treatment alternatives. The combination of inavolisib with existing therapies like palbociclib and fulvestrant is expected to enhance the efficacy of the treatment regimen, providing hope for better disease management and improved quality of life for patients battling this aggressive form of breast cancer. The FDA’s decision reflects the compelling clinical data supporting inavolisib’s benefits and underscores the agency’s commitment to fast-tracking innovative treatments that can make a meaningful difference in the lives of patients.

Inavolisib, evaluated in the Phase III INAVO120 study, demonstrated a significant improvement in progression-free survival, reducing the risk of disease worsening or death by 57% compared to standard treatment. Patients receiving the inavolisib-based regimen experienced a median progression-free survival of 15 months versus 7.3 months with the control regimen.

The INAVO120 study included 325 patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. In addition to progression-free survival, the study also showed a positive trend in overall survival, although the data were immature at the time of primary analysis. Further follow-up is ongoing.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, highlighted the significance of these findings, stating that inavolisib has the potential to extend survival for people with PIK3CA-mutated metastatic breast cancer. The FDA’s Priority Review designation aims to expedite the availability of this promising treatment option.

The PIK3CA mutation is present in approximately 40% of hormone receptor-positive metastatic breast cancers. Early identification of these mutations can help tailor treatment strategies and improve patient outcomes. The FDA has set a target action date of 27 November 2024 for its decision on inavolisib.

Breast cancer

New Hope for PIK3CA-Mutated Breast Cancer

Inavolisib is also being investigated in other Phase III studies for different combinations and indications. These studies include INAVO121 and INAVO122, which are evaluating the efficacy and safety of inavolisib in various combinations for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The INAVO121 study is comparing inavolisib plus fulvestrant against alpelisib plus fulvestrant in patients whose disease progressed after treatment with a cyclin-dependent kinase 4/6 inhibitor and endocrine therapy combination.

Meanwhile, the INAVO122 study is assessing the combination of inavolisib with pertuzumab and trastuzumab for subcutaneous injection, compared to the standard combination of pertuzumab and trastuzumab, in patients with HER2-positive disease. These studies aim to explore the potential of inavolisib in different therapeutic settings and patient populations, thereby broadening the scope of its clinical application.

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Additional data from the INAVO120 study will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 31 May to 04 June. This presentation will provide further insights into the efficacy and safety of this promising therapy, highlighting its potential to significantly improve outcomes for patients with advanced breast cancer. The ASCO Annual Meeting is a prestigious platform where leading oncologists and researchers gather to share the latest advancements in cancer treatment.

The inclusion of inavolisib in this year’s program underscores its importance in the current landscape of breast cancer research. Attendees can expect detailed analyses of progression-free survival, overall survival, and other secondary endpoints from the INAVO120 study. These findings will contribute to the growing body of evidence supporting inavolisib’s role as a transformative treatment option for patients with PIK3CA-mutated breast cancer.



Resource: Roche, May 20, 2024

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