Truqap™ (capivasertib) plus fulvestrant now available in Canada

MISSISSAUGA, ON, May 31, 2024 /CNW/ - AstraZeneca is pleased to announce that Truqap™ (capivasertib) in combination with fulvestrant is now available in Canada for the treatment of adult female patients 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 or PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.1

Truqap was approved by Health Canada in January 2024 based on the results from the CAPItello-291 Phase III trial published last year in The New England Journal of Medicine.2 In the trial, Truqap in combination with fulvestrant reduced the risk of disease progression or death by 50% versus fulvestrant alone in patients with tumours harbouring PIK3CA/AKT1/PTEN biomarker alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months).

"There is significant unmet need for patients with advanced HR-positive, HER2-negative breast cancer, who typically experience tumour progression or resistance with commonly used first-line endocrine therapies," says Dr. Jan-Willem Henning, Chair of the REAL Canadian Breast Cancer Alliance and Medical Oncologist, Tom Baker Cancer Centre and Clinical Associate Professor, Cumming School of Medicine, University of Calgary. "It's great news for Canadian patients that this first-of-its-kind combination is now available, providing a much-needed new treatment option which may delay disease progression and the need to start chemotherapies, which may allow patients a better quality of life."

In the CAPItello-291 trial, the safety profile of Truqap plus fulvestrant was similar to that observed in previous trials evaluating this combination. The most common adverse reactions reported for patients receiving Truqap in combination with fulvestrant (reported at a frequency of ≥10%) were diarrhea (67.3%), cutaneous adverse reaction (46.5%), nausea (27.3%), fatigue (22%), stomatitis (16.3%), vomiting (15.8%) and hyperglycemia (14.1%).2

"It's promising to hear that Truqap is now available for Canadians with HR-positive, HER2-negative breast cancer. Patients live with the concern that they'll become resistant to other therapies and that their cancer will grow," says Kimberly Carson, CEO, Breast Cancer Canada. "Additional treatment options bring new opportunities for personalized care that is tailored to the needs of the individual. Improving the lives of patients is moving the needle forward — and we look forward to the provinces' progress in making Truqap accessible across the country."

Breast cancer is the most common cancer among Canadian women (excluding non-melanoma skin cancers) and is the second leading cause of death from cancer in Canadian women.3 HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype, with more than 65% of tumours considered HR-positive and HER2-low or HER2-negative.4 Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN occur frequently, affecting up to 40% of patients with advanced HR-positive breast cancer.5,6,7 Endocrine therapies are widely used in this setting, but many patients develop resistance to 1st-line cyclin-dependent kinase (CDK) 4/6 inhibitors and estrogen receptor-targeting therapies, underscoring the need for additional endocrine therapy-based options.8

CAPItello-291
CAPItello-291 is a Phase III, double-blind, randomized trial evaluating the efficacy of Truqap in combination with fulvestrant versus placebo plus fulvestrant for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative (immunohistochemistry (IHC) 0 or 1+, or IHC 2+/in-situ hybridisation (ISH)-negative) breast cancer.

The global trial, with Canadian participation, enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN genes). In the trial, approximately 40% of tumours had these alterations and approximately 70% of patients received a prior CDK4/6 inhibitor.2

Truqap
Truqap (capivasertib) is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs approximately 1,800 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer.

AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at www.astrazeneca.ca.

TRUQAPTM is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

References

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1 TruqapTM (capivasertib tablets), Product Monograph, AstraZeneca Canada Inc., January 24, 2024.

2 Turner N, et al. Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer. NEJM. 2023; 388:2058–70.

3 Canadian Cancer Society. Breast Cancer Statistics. Available at: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics. Accessed on May 16, 2024.

4 National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed on May 16, 2024.

5 Howell S J, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION). J Clin Oncol. 2022; 23:851-64.

6 Hortobagyi G N, et al. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016; 34:419-26.

7 Millis S Z, et al. Landscape of phosphatidylinositol-3-kinase pathway alterations across 19784 diverse solid tumors. JAMA Oncol. 2016;2(12):1565-73.

8 Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022; 28(5):821-30.

SOURCE AstraZeneca Canada Inc.

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