TRUQAP™ (capivasertib)

FOR IMMEDIATE RELEASE:

TRUQAP™ (capivasertib) Now Available from Onco360 for the Treatment of Adult Patient with Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced or Metastatic Breast Cancer with One or More PIK3CA/AKT1/PTEN-Alterations

Louisville, KY — November 20, 2023 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by AstraZeneca for Truqap^™ (capivasertib). Truqap^™ is an oral targeted therapy for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne^®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

“Onco360 is excited to partner with the team at AstraZeneca and become a specialty pharmacy provider for Truqap^™,” said Benito Fernandez, Chief Commercial Officer. “We continue to see therapeutic advancements that are helping to further our mission of improving the lives of patients battling cancer, rare, and orphan disease. Truqap^™ provides another treatment option for adult patients with advanced or metastatic breast cancer to our portfolio of oncology products.”

The National Cancer Institute estimates 297,790 new cases of breast cancer will be diagnosed in 2023, representing 15.2% of all new cancer cases in the U.S.¹ Breast cancer is the most frequently diagnosed cancer and the fourth leading cause of death in the U.S. The 5-year overall survival (OS) for HR+/HER2- breast cancer cases is approximately 90.8%. The five-year overall survival (OS) for metastatic breast cancer patients is only 31%. Only 6% of breast cancer patients will have metastatic disease at the time of initial diagnosis. PIK3CA mutations occur in 38.6%, AKT1 mutations occur in 7.1%, and PTEN alterations occur in 7% of metastatic breast cancer patients.²

The efficacy of Truqap^™ was evaluated in the CAPItello-29 trial³, a randomized, double-blind, placebo-controlled, multicenter trial in 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations. All patients were required to have progression on aromatase inhibitor-based treatment. Patients could have received up to two prior lines of endocrine therapy and up to 1 line of chemotherapy for locally advanced or metastatic disease.

Patients were randomized to either capivasertib 400 mg or placebo administered orally twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Both patient arms received Fulvestrant 500 mg intramuscularly on cycle 1 days 1 and 15, and then every 28 days thereafter. Patients received therapy until disease progression or unacceptable toxicity.

Of the 289 patients with PIK3CA/AKT1/PTEN-altered tumors, the median progression free survival (PFS) was 7.3 months (95% CI: 5.5-9.0) in the capivasertib-fulvestrant group and 3.1 months (95% CI: 2.0-3.7) in the placebo-fulvestrant group (Hazard Ratio 0.50 [95% CI: 0.38-0.65]).

The most common adverse reactions with an incidence of at least 20%, including laboratory abnormalities were diarrhea, cutaneous skin reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, vomiting, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, and stomatitis.   

Please see the full Prescribing Information for Truqap^™.

Media Contact:
Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

1. National Cancer Institute. Cancer Stat Facts: Breast cancer. Accessed November 2023. https://seer.cancer.gov/statfacts/html/breast.html.
2. Li, A, et al. Genomic Alterations in Metastatic Breast Cancer and it’s Treatment. Am Soc Clin Oncol Book. 2020. Mar:40:1-14.
3. Turner NC, Oliveira M, Howell SJ, et al.for the CAPItello-291 Study Group. Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer. N Engl J Med 2023;388:2058-2070.

Trademarks:

AstraZeneca, Truqap^™ and associated logos are registered trademarks of the AstraZeneca group of companies.