Samsung Medical Center
🇰🇷South Korea
- Country
- 🇰🇷South Korea
- Ownership
- Subsidiary
- Established
- 1994-01-01
- Employees
- 501
- Market Cap
- -
Nelonemdaz Shows Promise in Treating Out-of-Hospital Cardiac Arrest Patients
A recent clinical trial has highlighted the potential of Nelonemdaz in treating patients who have suffered out-of-hospital cardiac arrest. The study, supported by the Ministry of Health and Welfare of the Republic of Korea and GNT Pharma, involved multiple institutions and adhered to strict ethical guidelines, offering new hope for improving survival and recovery outcomes.
J&J's Rybrevant and Lazcluze Combo Shows Survival Benefit Over Tagrisso in Lung Cancer
• Johnson & Johnson's Rybrevant and Lazcluze combination therapy significantly improved overall survival compared to AstraZeneca's Tagrisso in first-line NSCLC.
• The MARIPOSA trial demonstrated a clinically meaningful and statistically significant survival benefit, potentially exceeding one year compared to Tagrisso.
• This combination therapy targets both EGFR and MET pathways, offering a new approach to combat resistance in EGFR-mutated non-small cell lung cancer.
• While effective, the Rybrevant/Lazcluze regimen presents challenges including infusion administration and a higher rate of side effects compared to Tagrisso.
Iparomlimab/Tuvonralimab Plus Chemotherapy Shows Promise in Recurrent/Metastatic Cervical Cancer
• Updated phase 2 DUBHE-C-204 trial data shows iparomlimab/tuvonralimab with chemotherapy, with or without bevacizumab, yields a 75.9% objective response rate in recurrent/metastatic cervical cancer.
• The combination therapy demonstrated a disease control rate of 98.3% and a median progression-free survival of 15.1 months in the efficacy-evaluable population.
• Survival benefits were observed regardless of PD-L1 CPS status, suggesting broad applicability of the iparomlimab/tuvonralimab combination in this patient population.
• A phase 3 trial is ongoing to further evaluate the efficacy and safety of iparomlimab/tuvonralimab plus chemotherapy with or without bevacizumab in this setting.
Amgen's Tarlatamab Nears Korean Approval for Small Cell Lung Cancer Treatment
Amgen's breakthrough bispecific antibody tarlatamab, already FDA-approved for small cell lung cancer (SCLC), is approaching regulatory approval in Korea with a decision expected in first half of 2024. The drug's development featured significant Korean contribution, including 93 therapeutic use cases and leadership in clinical trials, addressing a critical need in SCLC treatment landscape.
Individualized Blood Pressure Management in Major Surgery: SPROUT-4 Trial
• The SPROUT-4 trial is a multicenter, randomized controlled trial evaluating individualized blood pressure management versus conventional methods during major noncardiac surgery.
• High-risk patients aged ≥65 years or ≥45 years with cardiovascular risk factors will be enrolled to assess the impact on postoperative outcomes.
• The primary outcome is a composite of all-cause death, stroke, myocardial infarction, heart failure, revascularization, and acute kidney injury within 7 days.
• The trial aims to determine if maintaining blood pressure at 20% below baseline reduces adverse events compared to maintaining a MAP ≥65 mmHg and SBP ≥90 mmHg.
GI Innovation Doses First Patient in Phase 1 Trial of Subcutaneous Immunotherapy GI-102 for Melanoma
• GI Innovation initiated a Phase 1 clinical trial of GI-102, a subcutaneous (SC) immune-oncology drug, marking the first such attempt by a Korean firm.
• The trial, conducted across 14 medical institutions in Korea and the U.S., evaluates GI-102's potential in treating melanoma and other indications.
• Preclinical data suggests GI-102's SC formulation may enhance efficacy compared to IV administration, showing a 30% objective response rate in metastatic melanoma patients.
• The Phase 1 trial is expected to conclude by February 2025, with global pharmaceutical companies showing interest in clinical data for potential technology licensing.
Ibrance Combo Extends Progression-Free Survival in HR+, HER2+ Metastatic Breast Cancer
• Pfizer's Ibrance, combined with anti-HER2 and endocrine therapies, significantly improved progression-free survival in HR+, HER2+ metastatic breast cancer patients.
• The Phase 3 PATINA trial showed a median PFS of 44.3 months with the Ibrance combination, compared to 29.1 months with anti-HER2 and endocrine therapies alone.
• The Ibrance combination demonstrated a manageable safety profile, with common adverse events including neutropenia, leukopenia, fatigue, stomatitis, and diarrhea.
• These findings suggest Ibrance may overcome resistance to existing therapies and could become a new standard of care for this specific breast cancer subtype.
Curocell's CAR-T Therapy Rimqarto (Anbal-cel) Nears South Korean Market Launch
• Curocell's Rimqarto (Anbal-cel), a CAR-T therapy for relapsed or refractory large B-cell lymphoma (LBCL), is nearing market launch in South Korea.
• Rimqarto demonstrated a 67.1% complete response rate in Phase 2 clinical trials, showcasing its efficacy and safety profile.
• The therapy has been granted orphan drug designation and is under expedited review for approval and reimbursement in South Korea.
• Curocell is also exploring global expansion opportunities for Rimqarto, including potential partnerships in South America, the Middle East, and Southeast Asia.
Aptamer Sciences' Liver Cancer Drug, AST-201, Enters Phase 1 Trials in Korea
• Aptamer Sciences initiates Phase 1 clinical trials for AST-201, a novel aptamer-based drug for liver cancer, across four Korean medical institutions.
• The trial will assess the safety and tolerability of AST-201 in up to 36 patients with GPC3-positive advanced solid tumors, with potential efficacy exploration.
• AST-201 utilizes Aptamer-Drug Conjugate (ApDC) technology, offering targeted drug delivery to cancer cells with reduced side effects.
• First dosing is anticipated in January, with initial data expected in the first half of the following year, according to Aptamer Sciences.
GC Biopharma and Novel Pharma Initiate Phase I Trial of GC1130A for Sanfilippo Syndrome Type A
• GC Biopharma and Novel Pharma have dosed the first patient in a multinational Phase I clinical trial of GC1130A for Sanfilippo syndrome type A (MPS IIIA).
• The Phase I trial will assess the safety, tolerability, and efficacy of GC1130A in children aged 2-6 years with MPS IIIA over a two-year period.
• GC1130A is a first-in-class treatment using GC Biopharma’s platform to deliver concentrated recombinant protein via intracerebroventricular (ICV) injection.
• The trial will be conducted across multiple sites in the US, Korea, and Japan, addressing a critical unmet need for this devastating genetic disorder.
Alzheimer's Blood Tests Poised for FDA Approval and Clinical Integration
• Plasma p-tau217 assays are demonstrating high accuracy, potentially serving as effective triage tests for Alzheimer's disease and meeting criteria for clinical use.
• Several vendors, including Fujirebio and Roche Diagnostics, have submitted applications to the FDA for approval of their Alzheimer's blood tests, with potential approval in 2025.
• Studies emphasize the need for real-world data and physician education to ensure appropriate use of these tests in diverse clinical settings and to avoid misdiagnosis.
• CMS reimbursement rates are under discussion, with concerns raised about proposed rates potentially hindering test implementation despite their clinical value.
Pharos iBio's PHI-101 Demonstrates Promising Complete Response in AML Phase 1 Trial
• Pharos iBio's PHI-101, a first-in-class treatment for acute myeloid leukemia (AML), achieved a 50% overall complete response rate in a Phase 1 study.
• The study included patients who relapsed or failed after prior FLT3 inhibitor therapy, with 75% falling into this category, highlighting PHI-101's potential.
• Pharos iBio plans to complete Phase 1 and file an IND application for a global Phase 2 trial, aiming for early commercialization via conditional marketing authorization.
• Data from the expanded Phase 1b study of PHI-101-AML will be presented at the American Society of Hematology (ASH) Annual Meeting in December.
Osimertinib Plus Savolitinib Shows Promise in MET-Aberrant EGFR-Mutant NSCLC
• Osimertinib combined with savolitinib demonstrated a 90.5% objective response rate in first-line treatment of MET-aberrant, EGFR-mutant advanced NSCLC, significantly higher than osimertinib alone (60.9%).
• The combination therapy showed deeper and more durable responses, with a median duration of response of 18.6 months compared to 8.4 months for osimertinib monotherapy.
• Grade 3 or higher treatment-related adverse events were more frequent in the combination arm (57.1%) than in the monotherapy arm (8.7%), but were considered manageable.
• SAVANNAH trial data indicates that osimertinib plus savolitinib generates durable responses in EGFR-mutant, MET-amplified NSCLC who experienced disease progression on osimertinib.
TAGRISSO and ORPATHYS Combination Shows Promise in MET-Driven EGFR-Mutated NSCLC
• The combination of TAGRISSO® (osimertinib) and ORPATHYS® (savolitinib) demonstrated a high, clinically meaningful objective response rate (ORR) in NSCLC patients.
• The SAVANNAH Phase II trial targeted EGFR-mutated NSCLC patients with high levels of MET overexpression or amplification after TAGRISSO® treatment failure.
• ORPATHYS®, a selective MET tyrosine kinase inhibitor, addresses MET-driven resistance, a common mechanism in EGFR-targeted therapy for NSCLC.
• The ongoing SAFFRON Phase III trial will further evaluate the TAGRISSO® plus ORPATHYS® combination versus platinum-based chemotherapy.
Sacituzumab Govitecan Demonstrates Efficacy in HR+/HER2- Metastatic Breast Cancer
• Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) compared to chemotherapy in patients with HR+/HER2- metastatic breast cancer.
• The phase 3 EVER-132-002 trial included patients who had received two to four prior chemotherapy regimens, showing SG's benefit in heavily pre-treated populations.
• SG demonstrated a manageable safety profile, supporting its potential as a valuable treatment option for this patient population in regions including mainland China, Republic of Korea and Taiwan.
• The study's findings contribute to addressing the unmet need for effective therapies in HR+/HER2- metastatic breast cancer, particularly after multiple lines of treatment.
ROTEM-Guided TXA Administration vs. Preemptive TXA for Bleeding in Cardiovascular Surgery: A Randomized Trial
• A multi-center, double-blind, randomized trial is underway to compare ROTEM-guided tranexamic acid (TXA) administration with preemptive TXA in cardiovascular surgery patients.
• The study aims to determine if ROTEM-guided TXA is non-inferior to preemptive TXA in reducing postoperative blood loss, with recruitment ongoing until December 2024.
• The trial will also assess secondary outcomes such as blood transfusion rates, coagulation profiles, thromboembolic complications, and hospital costs.
• Findings from this pragmatic trial will inform clinical practice by evaluating the effectiveness of ROTEM-guided TXA in real-world settings.
Myongji Hospital Develops AI-Powered Tool to Predict Ovarian Cancer Drug Resistance
• A research team at Myongji Hospital has developed the Ovarian Cancer Assay, a diagnostic tool to predict chemotherapy resistance in ovarian cancer patients.
• The tool uses deep neural network models and gene data analysis to predict resistance to platinum-based chemotherapy with 85% accuracy.
• Clinical trials are set to begin, supported by precision medicine companies, to validate the tool's effectiveness in personalizing ovarian cancer treatment.
• Key genes and pathways, including TP53, E2F1, and MYC1, were identified as important factors in understanding chemotherapy resistance mechanisms.
GI Innovation and MSD Collaborate on GI-102 and Keytruda Combination Trial for Resistant Cancers
• GI Innovation partners with MSD to evaluate GI-102 combined with Keytruda (pembrolizumab) in a Phase II trial.
• The trial targets metastatic liver cancer, melanoma, and renal cell carcinoma patients resistant to immunotherapy.
• GI-102 previously demonstrated a 42.9% overall response rate in melanoma patients unresponsive to standard treatments.
• The study will be conducted across 14 hospitals in South Korea and multiple sites in the US, including Mayo Clinic and Memorial Sloan Kettering.
Cancer Immunotherapy Market Set to Reach USD 296 Billion by 2033, Growing at 8.9% CAGR
• The global cancer immunotherapy market is projected to grow from USD 126.19 billion in 2023 to USD 296.01 billion by 2033, with North America maintaining its dominant position at 45% market share.
• Monoclonal antibodies currently dominate the market with 67% revenue share, while oncolytic viral therapies and cancer vaccines are expected to show significant growth in coming years.
• Recent regulatory approvals, including FDA's authorization of ANKTIVA for bladder cancer and Amtagvi for melanoma, highlight the sector's innovation and expansion potential.
Initial TNF-α Levels Predict Infliximab Response in Pediatric Crohn's Disease
• A recent study reveals that initial levels of TNF-α can predict the treatment response to Infliximab (IFX) in pediatric Crohn's Disease (CD).
• Higher initial TNF-α concentrations correlate with lower IFX trough concentrations, potentially leading to suboptimal therapeutic effects.
• A TNF-α cutoff value of 27.6 pg/mL was identified, above which higher IFX doses may be needed to maintain therapeutic concentrations.
• Measuring initial cytokine levels could help personalize IFX dosing strategies, improving treatment outcomes for pediatric CD patients.
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