Truqap™ and fulvestrant now available in Canada

AstraZeneca has announced the availability of Truqap™ (capivasertib) in combination with fulvestrant in Canada, designed for adult female patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This new treatment is intended for patients with PIK3CA, AKT1, or PTEN alterations, following progression on at least one endocrine-based regimen in the metastatic setting, or recurrence within a year of completing adjuvant therapy.

Health Canada approved Truqap in January 2024, based on the findings of the CAPItello-291 Phase III trial, which were published in The New England Journal of Medicine. This study demonstrated that Truqap combined with fulvestrant decreased the risk of disease progression or death by 50% compared to fulvestrant alone in patients with tumors exhibiting PIK3CA/AKT1/PTEN biomarker alterations. The median progression-free survival (PFS) for the combination treatment was 7.3 months versus 3.1 months for fulvestrant alone.

Dr. Jan-Willem Henning, Chair of the REAL Canadian Breast Cancer Alliance and Medical Oncologist at the Tom Baker Cancer Centre, expressed optimism about the new treatment option. He highlighted the significant need for advanced HR-positive, HER2-negative breast cancer patients who often face tumor progression or resistance with first-line endocrine therapies. He emphasized that this combination treatment could provide a better quality of life by delaying disease progression and the need for chemotherapy.

The CAPItello-291 trial evaluated the safety and efficacy of Truqap plus fulvestrant, and the safety profile was consistent with previous studies. Common adverse reactions experienced by patients included diarrhea (67.3%), cutaneous reactions (46.5%), nausea (27.3%), fatigue (22%), stomatitis (16.3%), vomiting (15.8%), and hyperglycemia (14.1%).

Kimberly Carson, CEO of Breast Cancer Canada, welcomed the availability of Truqap in Canada, noting that additional treatment options mean more personalized care for patients. She emphasized the importance of improving the lives of breast cancer patients and expressed anticipation for the provinces to make Truqap more widely accessible.

Breast cancer remains the most common cancer among Canadian women, aside from non-melanoma skin cancers, and is the second leading cause of cancer death among women in Canada. HR-positive breast cancer, which expresses estrogen or progesterone receptors, is the most common subtype, accounting for over 65% of tumors, which are either HER2-low or HER2-negative. Mutations in PIK3CA, AKT1, and alterations in PTEN are frequent, affecting up to 40% of advanced HR-positive breast cancer patients. Endocrine therapies are commonly used, but many patients develop resistance, highlighting the need for new endocrine-based options.

The CAPItello-291 trial was a global, double-blind, randomized Phase III study that included 708 adult patients with HR-positive, HER2-low or negative breast cancer. These patients had either recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and had received up to one line of chemotherapy for advanced disease. The trial's primary endpoints were PFS in the overall patient population and in those with PI3K/AKT pathway alterations. Notably, around 40% of tumors had these alterations, and about 70% of patients had previously received a CDK4/6 inhibitor.

Truqap™ (capivasertib) is a potent, ATP-competitive inhibitor targeting all three AKT isoforms (AKT1/2/3). It is administered at a dose of 400mg twice daily, following an intermittent dosing schedule of four days on and three days off, based on early phase trials.

AstraZeneca, a global biopharmaceutical company, focuses on Oncology, Cardiovascular, Renal and Metabolic diseases, Rare Diseases, Respiratory and Immunology, and Vaccine & Immune Therapies. The company employs around 1,800 people in Canada and has recently expanded its research footprint in Mississauga. AstraZeneca is also recognized for its commitment to sustainability, having its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!