FDA Approves Itovebi: A New Targeted Therapy For Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Itovebi™ (inavolisib), developed by Genentech, a member of the Roche Group, in combination with palbociclib and fulvestrant, for the treatment of adults with endocrine-resistant.
PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
Significant Improvement In Progression-Free Survival
The approval is based on the results of the Phase III INAVO120 clinical trial, which demonstrated that the Itovebi-based regimen more than doubled progression-free survival (PFS) compared to palbociclib and fulvestrant alone.
Specifically, patients receiving the Itovebi combination achieved a median PFS of 15.0 months versus 7.3 months in the control group, representing a 57% reduction in the risk of disease progression or death (hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001).
Although overall survival (OS) data were immature at the time of the primary analysis, a positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338), and follow-up for OS is ongoing.
Addressing An Unmet Need In Breast Cancer Treatment
Approximately 40% of HR-positive metastatic breast cancers harbor PIK3CA mutations, which are associated with poor prognosis and resistance to standard endocrine therapies.
The approval of Itovebi offers a new first-line treatment option for this patient population, addressing a significant unmet medical need.
Dr. Komal Jhaveri, one of the principal investigators of the INAVO120 study, stated.
“The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated.”
Companion Diagnostic And Future Research
The FDA also approved the FoundationOne® Liquid CDx assay as a companion diagnostic to identify patients with PIK3CA mutations who may benefit from the Itovebi-based regimen.
Genentech is conducting additional Phase III clinical trials (INAVO121, INAVO122, and INAVO123) to further evaluate the efficacy of Itovebi in various combinations and settings, aiming to expand its use in treating PIK3CA-mutated breast cancer.
Itovebi Efficacy And Safety
INAVO120 (NCT04191499) was a randomized, double-blind, placebo-controlled, multicenter clinical trial.
It included 325 patients with endocrine therapy-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer.
These patients experienced disease progression during or within 12 months of completing adjuvant endocrine therapy and had not received prior systemic therapy for locally advanced or metastatic breast cancer.
Primary endocrine therapy resistance is defined as recurrence within 2 years prior to adjuvant endocrine therapy (ET).
Secondary endocrine therapy resistance was defined as relapse after at least 2 years of adjuvant endocrine therapy or within 12 months of completion of adjuvant endocrine therapy.
The FDA approval of Itovebi marks a significant advancement in the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer.
By offering a targeted therapy that significantly improves progression-free survival, Itovebi provides a new hope for patients facing this challenging disease.
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