Korea University Anam Hospital

Truqap, the first AKT inhibitor, has arrived in Korea, offering new hope for HR+/HER2- breast cancer patients with PIK3CA, AKT1, and PTEN mutations. Despite its potential, challenges like the domestic diagnostic environment and drug reimbursement limit its impact. Professor Park Kyong-hwa highlights unmet needs in HR+/HER2- treatment, Truqap's clinical benefits, and the importance of genetic analysis for precision medicine.

A multicenter, randomized, double-blind study evaluated the antihypertensive efficacy and safety of AML plus CC versus AML monotherapy in Korean patients with uncontrolled essential hypertension. Patients underwent a 4-week AML monotherapy run-in period, followed by randomization to combination therapy or AML monotherapy for 8 weeks. The primary outcome was DBP change at week 8, with additional assessments at weeks 4, 12, and 16. Safety was monitored through adverse events. The study aimed for KMFDS approval for the AML/CC fixed-dose combination.

EVER-132-002 study, compliant with Helsinki and ICH GCP guidelines, was approved by national authorities and ethics committees. It enrolled HR+HER2- metastatic or locally recurrent BC patients from China, Korea, and Taiwan, requiring prior chemotherapy and measurable disease. Patients were randomized 1:1 to receive SG or chemotherapy, with PFS as the primary endpoint. Secondary endpoints included OS, ORR, DoR, CBR, safety, and QoL. Assessments involved tumor measurements, safety evaluations, and QoL questionnaires. Statistical analysis included sample size calculation, HR estimation, and safety summaries. The study design details are available in the Nature Portfolio Reporting Summary.

AstraZeneca Korea launched Truqap, the first AKT inhibitor for HR+/HER2- breast cancer, targeting PIK3CA, AKT1, or PTEN mutations. Truqap, approved in April, offers new hope for patients progressing after endocrine therapy. The CAPItello-291 study showed Truqap plus fulvestrant doubled median progression-free survival to 7.3 months. Despite financial concerns over NGS costs, global guidelines recommend mutation testing for effective treatment.