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Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated positive overall survival results.
Itovebi-based treatment generated positive overall survival results among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer.
Among patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer, treatment with Itovebi (inavolisib) plus Ibrance (palbociclib) and fulvestrant generated positive topline overall survival (OS) results in the phase 3 INAVO120 study, according to a press release from Roche.
The key secondary endpoint of a statistically significant and clinically meaningful OS benefit was met with the Itovebi-based treatment versus treatment with Ibrance and fulvestrant alone in the first-line treatment setting. Moreover, in the press release, investigators shared that Itovebi-based regimen reached statistical significance, more than doubling progression-free survival (PFS) in patients, and no new safety signals were observed since the previous analysis.
“The INAVO120 OS results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients.”
HR-positive breast cancer accounts for approximately 70% of breast cancer cases and is characterized by tumor cells with estrogen or progesterone receptors that drive growth. Patients with HR-positive metastatic disease often face disease progression and treatment-related side effects, creating a gap and care and a need for additional therapies. Dysregulation of the PI3K signaling pathway has been identified as a potential mechanism of intrinsic resistance to standard endocrine therapy combined with CDK4/6 inhibitors. Therefore, investigators launched the INAVO120 clinical trial of Itovebi.
Disease progression: the process by which cancer worsens and spreads to other parts of the body.
Overall survival (OS): the average amount of time that a patient survives after their cancer diagnosis or treatment.
Progression-free survival (PFS): the amount of time a patient lives with cancer after treatment without the disease worsening.
Itovebi is an oral, targeted treatment with the potential to be a best-in-class treatment option for eligible patients with HR-positive, HER2-negative breast cancer who often have a poor prognosis and are in urgent need of new treatment options; the agent can provide well-tolerated, durable disease control and potentially improved outcomes. Furthermore, Itovebi is differentiated from other PI3K inhibitors due to its high potency, specificity and unique mechanism of action, and is designed to help minimize the overall burden and toxicity of treatment.
INAVO120 IS a randomized, double-blind, placebo-controlled trial which is studying the efficacy and safety of Itovebi plus Ibrance and fulvestrant compared with placebo plus Ibrance and fulvestrant in participants with HR-positive, HER2-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
In total, 325 patients were randomly assigned to either the investigational or control treatment arm. PFS, as assessed by investigators and defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause, was the primary end point of the study. OS, objective response rate and clinical benefit rate all served as secondary end points.
The OS results from INAVO120 build upon previously reported data on the Itovebi-based regimen, which showed that the investigational treatment reduced the risk of disease worsening or death by 57% compared with Ibrance and fulvestrant alone in the first-line setting. Although OS data were immature at the time of the primary analysis, the press release state there was still a clear positive trend observed at that time of the primary analysis.
Notably, in October of 2024, the U.S. Food and Drug Administration (FDA) approved the Itovebi-based regimen for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy.
Beyond INAVO120, Itovebi is also being investigated in other phase 3 clinical studies including the INAVO120, INAVO121, INAVO122 and INAVO123 clinical trials for patients with in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations. However, the company plans to explore Itovebi in additional studies across other tumor types with the hope of offering another targeted therapy to more people with PIK3CA-mutated cancer and addressing patient unmet needs.
The press release concluded by sharing that full OS results from INAVO120 will be shared at an upcoming medical meeting.
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