Seoul National University Hospital

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.

Cellvion CEO Kim Kwon announces plans for IPO on KOSDAQ, focusing on Lu-177-DGUL, a prostate cancer treatment with superior objective response rate and fewer side effects compared to Novartis' Pluvicto. The drug, set for early release in October next year, targets a 7.4% market share with a product price of 27 million won, aiming for 42.9 billion won in sales by 2027. General subscription for the IPO is scheduled for the 7th to 8th of next month.

A research team led by Professor Song Yong-sang developed a diagnostic method to predict chemotherapy resistance in ovarian cancer patients using a tool called the Ovarian Cancer Assay. The method, with 85% accuracy and 100% sensitivity, identifies 31 key genes linked to resistance, focusing on platinum-based chemotherapy. Clinical trials are set to begin, involving multiple institutions and supported by precision medicine companies.

Samjin Pharmaceutical held a symposium at the Grand Hyatt Seoul on Aug. 24-25 to mark the 17th anniversary of Platless Tab (clopidogrel) launch, focusing on clinical research updates. Over 100 cardiologists attended, with lectures on long-term maintenance after coronary stenting and the HOST-PREVENTION study, which aims to expand clopidogrel's therapeutic area to primary prevention therapy.

GI Innovation and MSD collaborate on a Phase 2 trial combining GI-102 and KEYTRUDA for resistant liver cancer, melanoma, and renal cell carcinoma.

GI Innovation and Merck & Co (MSD) collaborate on a Phase II trial to assess GI-102 combined with Keytruda for metastatic liver cancer, melanoma, and renal cell carcinoma. The trial, conducted in South Korea and the US, aims to provide treatment options for patients resistant to immuno-oncology treatments.