FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
Genentech's Inavolisib has received Breakthrough Therapy Designation from the FDA for treating advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. This designation is expected to expedite the development and review process, potentially bringing the treatment to market faster. Alvotech announced participation in the upcoming BofA Securities Healthcare Conference 2024 on May 14-15 in Las Vegas, where its management team will meet with investors.
- FDA Breakthrough Therapy Designation can expedite the development and review process for Inavolisib.
- Targeting advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation addresses a significant medical need.
- Participation in BofA Securities Healthcare Conference 2024 provides Alvotech with an opportunity to engage directly with investors.
- The designation does not guarantee final FDA approval.
- The treatment is still under development, which involves inherent risks and uncertainties.
- Financial implications of R&D and clinical trials could impact Alvotech's short-term financial performance.
– The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting –
– Approximately
– This is the 29th Breakthrough Therapy Designation for Genentech’s oncology portfolio, a testament to our enduring ambition to deliver transformative medicines for patients –
“We are pleased that the FDA granted Breakthrough Therapy Designation for inavolisib in recognition of the substantial clinical benefit observed with this regimen,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “This promising inavolisib-based regimen could transform the PI3K inhibitor class, potentially becoming the standard of care for this patient population in the first-line setting.”
Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over existing therapies.
The FDA’s decision is based on positive Phase III INAVO120 results, which showed the inavolisib-based regimen reduced the risk of disease worsening or death (progression-free survival) by
PIK3CA is one of the most commonly mutated genes in advanced or metastatic breast cancer. Despite the prevalence of PIK3CA mutations, many patients are not tested until later in their treatment journey. Early testing for PIK3CA prior to initiating first-line treatment helps clinicians make a personalized treatment decision.
Data from INAVO120 are also being submitted to other global health authorities, including the European Medicines Agency.
Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations. We continue to evaluate potential clinical development program expansion opportunities to address patient unmet needs in various tumor types across oncology.
About inavolisib
Inavolisib is an investigational, oral targeted treatment with best-in-class potential that could provide well-tolerated, durable disease control and potentially improved outcomes for people with PIK3CA-mutated, HR-positive, HER2–negative, locally advanced or metastatic breast cancer, who often have a poor prognosis and are in urgent need of new treatment options. Inavolisib has been designed to help minimize the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.
About the INAVO120 study
The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (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.
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.
Beyond INAVO120, inavolisib is currently being investigated in two additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:
- in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and
- in combination with dual HER2 blockade vs dual HER2 blockade and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).
About Hormone Receptor-Positive Breast Cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately
About Genentech in Breast Cancer
Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in
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Source: Genentech
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