LOUISVILLE, Ky., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation's leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Genentech, a member of the Roche Group, for ITOVEBI™ (inavolisib) which is indicated, 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, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.1 This indication was approved based on the Phase III INAVO120 (NCT04191499) clinical trial, which compared patients receiving either Inavolisib or placebo with palbociclib and fulvestrant, in patients with PIK3CA mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer whose disease progressed during the treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.2 Inavolisib's approval helps patients with PIK3CA mutated breast cancer, a common mutated gene in hormone receptor positive disease, associated with a poor prognosis.3
Inavolisib is an inhibitor of phosphatidylinositol 3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. In vitro, inavolisib induced the degradation of mutated PI3K catalytic alpha subunit P110α (encoded by the PIK3CA gene), inhibited phosphorylation of the downstream target AKT, reduced cellular proliferation, and induced apoptosis in PIK3CA-mutated breast cancer cell lines.
"Onco360 is grateful for the opportunity to partner with the team at Genentech and become a specialty pharmacy provider for Itovebi™,” said Benito Fernandez. "We are proud to add another treatment option for advanced or metastatic breast cancer patients to our portfolio.”
INAVO120 clinical trial evaluated 325 patients, who were randomly assigned with Inavolisib or placebo plus palbociclib and fulvestrant. The primary endpoint was progression free survival (PFS), and the secondary endpoints included overall survival, objective response rate, and clinical benefit. INAVO120 showed Inavolisib plus palbociclib and fulvestrant regimen reduced the risk of disease worsening or death by 57% (15 months vs 7.3 months) compared to palbociclib and fulvestrant alone (HR=0.43, 95% CI 0.32-0.59) in the first line setting. The median duration of response with Inavolisib plus palbociclib and fulvestrant was 18.4 months compared to 9.6 months in the control arm. Overall survival (OS) data was immature at the time of primary analysis.
The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache.
Please see the full Prescribing Information for Itovebi™
About Onco360 Oncology Pharmacy:
Onco360 is the nation's largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com
516-640-1332
References:
1 ITOVEBI. Prescribing Information. Accessed October 2024. https://www.gene.com/download/pdf/itovebi_prescribing.pdf
2 Dejan, Juric et al.,First-line inavolisib/placebo + palbociclib + fulvestrant (Inavo/Pbo+Palbo+Fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 Phase III randomized trial additional analyses. JCO 42, 1003-1003(2024).
3 Anderson E, et al. Systematic Review of the prevalence and diagnostic workup of PIK3CA mutations in HR+/HER2- Metastatic breast cancer. Int J Breast Cancer. 2020; 2020:3759179.
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