AstraZeneca Launches Truqap (Capivasertib) in China, Offering a New Precision Therapy Option for HR-Positive, HER2-Negative Advanced Breast Cancer Patients in Combination with Fulvestrant

China Finance Network, June 13th: Today, AstraZeneca announced the official commercial launch of Truqap (Carfilzomib Tablets) in China.

Capivasertib in combination with fulvestrant was approved in China this April for adult patients with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and accompanied by one or more PIK3CA/AKT1/PTEN alterations, whose disease has progressed after receiving at least one endocrine therapy in the metastatic setting, or who have relapsed during adjuvant therapy or within 12 months after completing adjuvant therapy.

Capivasertib is the first and only AKT inhibitor approved in China for breast cancer patients with any specific biomarker (PIK3CA, AKT1, or PTEN) alteration. Studies show that in the Chinese population, compared to fulvestrant monotherapy, the combination of capivasertib and fulvestrant reduced the risk of disease progression or death by 59% (hazard ratio 0.41; median PFS 5.7 months vs 1.9 months) in patients with PIK3CA, AKT1, or PTEN gene alterations.

The latest "2024 China Cancer Statistics Report" released by the National Cancer Center shows that the incidence of breast cancer ranks second among malignant tumors in Chinese women. HR-positive, HER2-negative is the most common molecular subtype of breast cancer, accounting for approximately 80% of all breast cancer patients. Endocrine therapy combined with cyclin-dependent kinase (CDK)4/6 inhibitors is currently the first-line standard treatment for such patients. However, some patients still face disease progression or drug resistance, and there are no recommended standard treatment options thereafter, resulting in a heavy disease burden.

As breast cancer enters the era of precision diagnosis and treatment, abnormal activation of the PI3K/AKT/PTEN pathway has been identified as one of the key drivers of disease progression in HR-positive, HER2-negative breast cancer. In the Chinese population, approximately 57% of patients with HR-positive, HER2-negative breast cancer carry alterations in PIK3CA, AKT1, or PTEN, with proportions of those carrying PTEN or AKT1 alterations reaching as high as 8.4% and 7.7%, respectively. Capivasertib is a First-in-class AKT inhibitor that suppresses signaling activation across the entire PI3K/AKT/PTEN pathway by inhibiting all three isoforms (AKT1/2/3) at the central node of the pathway, offering benefits to a broader patient population.

As capivasertib becomes available in Beijing, Shanghai, Guangzhou, Chengdu and other places, HR-positive advanced breast cancer patients who have received CDK4/6i combined with endocrine therapy and have PIK3CA, AKT1, or PTEN alterations are welcoming a new option for precise targeted treatment.

Dongmei Guan, General Manager of AstraZeneca China Oncology, stated that AstraZeneca has been deeply involved in the breast cancer field for decades, with a rich product pipeline and a complete layout covering the three major molecular subtypes of breast cancer. In the future, AstraZeneca will accelerate the introduction of cutting-edge oncology drugs, collaborate with multiple parties to promote precision diagnosis and treatment of breast cancer, facilitate the transformation of innovative achievements into clinical practice, truly change the treatment outcomes for breast cancer patients in China, and help achieve the cancer prevention and treatment goals of "Healthy China 2030" as soon as possible.