Tuesday, June 18, 2024

FDA Approval for Inavolisib in Breast Cancer Treatment

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Roche’s investigational oral therapy, inavolisib. This designation is for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced, or metastatic breast cancer, following recurrence within 12 months of adjuvant endocrine treatment. This decision is based on positive Phase III INAVO120 results.

The INAVO120 study demonstrated that the inavolisib-based regimen more than doubled progression-free survival (PFS) compared to palbociclib and fulvestrant alone. Specifically, the study showed a 57% reduction in the risk of disease worsening or death, with a median PFS of 15.0 months versus 7.3 months. While overall survival data are still immature, a positive trend has been observed. Follow-up for overall survival will continue to the next analysis.

Inavolisib Offers Hope for PIK3CA-Mutated Breast Cancer

Approximately 40% of people with hormone receptor-positive breast cancer have a PIK3CA mutation, which is often associated with poorer prognosis and resistance to endocrine treatment. Despite this prevalence, many patients are not tested for PIK3CA mutations until later in their treatment journey. Early testing is crucial as it helps clinicians make personalized treatment decisions, optimizing patient outcomes.

Inavolisib is currently being investigated in three Phase III clinical studies (INAVO120, INAVO121, INAVO122) in various combinations for PIK3CA-mutated breast cancer. The INAVO120 study included 325 patients and evaluated the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant. Primary and secondary endpoints included progression-free survival, overall survival, objective response rate, and clinical benefit rate.

Inavolisib is an investigational, oral-targeted treatment with high potential. It is designed to provide well-tolerated, durable disease control for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer. Inavolisib aims to minimize treatment burden and toxicity, offering a unique mechanism that facilitates the degradation of mutated PI3K alpha, differentiating it from other PI3K inhibitors.

Breast Cancer

Roche’s Commitment to Breast Cancer Research

Roche has been a leader in breast cancer research for over 30 years, striving to help as many patients as possible. Their medicines and companion diagnostics have achieved significant breakthroughs in HER2-positive and triple-negative breast cancers. Roche’s commitment to innovation is evident in its extensive research and development efforts, which have led to the creation of pioneering treatments that have transformed the standard of care for these aggressive cancer types. Their portfolio includes targeted therapies that have significantly improved survival rates and quality of life for many patients worldwide.

In addition to their work on HER2-positive and triple-negative breast cancers, Roche continues to explore new biomarkers and treatments for various other subtypes of breast cancer. They are particularly focused on estrogen receptor-positive breast cancer, a common subtype of hormone receptor-positive breast cancer. This involves investigating the underlying mechanisms of cancer resistance and progression to develop more effective, personalized treatment strategies. By advancing our understanding of the molecular and genetic factors driving breast cancer, Roche aims to identify novel therapeutic targets and improve outcomes for patients across all stages of the disease.

Roche’s dedication extends beyond just developing new drugs. They are also investing in advanced diagnostic tools to ensure that patients receive the most accurate diagnoses and personalized treatment plans. Their work in personalized healthcare is designed to match the right treatment to the right patient at the right time, thereby optimizing therapeutic efficacy and minimizing side effects. This holistic approach underscores Roche’s unwavering commitment to enhancing patient care and advancing the fight against breast cancer on multiple fronts.

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Resource: Roche, May 21, 2024

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