AstraZeneca Korea has launched Truqap (ingredient: capivasertib), marking the availability of the first AKT inhibitor for breast cancer treatment in Korea. This offers a new therapeutic option for patients with hormone receptor-positive (HR+)/HER2-negative breast cancer, particularly those harboring PIK3CA, AKT1, or PTEN mutations. Truqap received regulatory approval in April and became available on Monday.
Indication and Usage
Truqap is indicated for adult patients with locally advanced or metastatic HR-positive/HER2-negative breast cancer who have PIK3CA, AKT1, or PTEN mutations and have experienced disease progression following endocrine therapy or relapse within 12 months of completing adjuvant therapy. It is to be administered in combination with fulvestrant, a commonly used breast cancer medication.
Clinical Evidence from CAPItello-291 Study
The approval of Truqap was primarily based on the results of the CAPItello-291 study. This pivotal trial demonstrated that the combination of Truqap and fulvestrant significantly improved the median progression-free survival (mPFS) compared to fulvestrant alone in patients who had previously failed first-line treatment with endocrine therapy (ET) with or without CDK4/6 inhibitors. The mPFS for patients receiving the Truqap and fulvestrant combination was 7.3 months, more than double the 3.1 months observed with fulvestrant monotherapy. Furthermore, the risk of disease progression or death was reduced by 50 percent in the combination arm.
Addressing Unmet Needs in Second-Line Therapy
Professor Park Kyong-hwa of the Department of Medical Oncology and Hematology at Korea University Anam Hospital highlighted the importance of Truqap in addressing the unmet needs in second-line therapy. She noted that approximately 50 percent of patients with HR-positive/HER2-negative breast cancer have one or more mutations in PIK3CA, AKT1, or PTEN, which can lead to rapid disease progression. "While first-line treatment options, such as CDK4/6 inhibitors, have provided benefits to many, resistance and subsequent disease progression remain significant challenges," Park said. As a result, there has been a continuous demand for second-line targeted therapies that specifically address these mutations.
Financial Obstacles and NGS Testing
Despite the promising clinical benefits of Truqap, concerns remain regarding the financial burden on patients. Next-generation sequencing (NGS), a genetic test required to identify the mutations targeted by Truqap, has become significantly more expensive following policy changes in December 2022. Patient out-of-pocket expenses for NGS increased to 80 percent, raising concerns about accessibility to personalized treatment strategies. "To improve treatment outcomes, it's crucial to quickly identify genetic mutations either at diagnosis or during first-line treatment," Park stated. She also emphasized that the increased NGS costs have made it difficult for many patients to undergo testing, which is vital not only for selecting new therapies like Truqap but also for determining whether hormone therapies or conventional treatments are appropriate.
Global Guidelines and Future Directions
Despite the financial barriers, global cancer guidelines from the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society for Medical Oncology (ESMO) all recommend testing for PIK3CA, AKT1, and PTEN mutations in metastatic breast cancer patients. Local experts are currently gathering data to advocate for broader insurance coverage of NGS testing to reduce the burden on patients. "We need to reconsider whether the cost of NGS is truly a hindrance when the results can help patients avoid unnecessary treatments or choose more effective options," Park said. "For patients facing the recurrence or metastasis of breast cancer, denying access to this test could have significant implications for their survival."
