Earticle

Immunotherapy has transformed cancer treatment in the past decade, with combinations of immune checkpoint inhibitors and conventional therapies showing promise across various cancers. This study reviews ongoing clinical trials of T cell receptor-T cell (TCR-T) therapies, analyzing their potential in targeting key cancer antigens for future treatment advancements. We examined data from ClinicalTrials.gov, focusing on phase 1-4 trials with reported results up to August 31, 2024. Trials were selected based on relevance to TCR-T cell therapy, safety and efficacy evaluation, and predefined inclusion/exclusion criteria. Thirty-three TCR-T clinical trials were identified, with 17 focusing on advanced cancers. Target antigens included New York esophageal squamous cell carcinoma (16 trials), melanoma-associated antigen (5 trials), and human papillomavirus 16 E (4 trials). Most studies targeted adults, with three involving pediatric patients. Sponsors included the National Cancer Institute and GlaxoSmithKline, with melanoma being the most studied cancer. One trial (NCT05066165) utilized CRISPR/Cas9 for non-viral TCR gene editing. Recent FDA approval of afamitresgene autoleucel, the first gene-modified TCR-T cell therapy targeting solid tumors, marks a significant milestone. TCR-T therapies are evolving into personalized cancer treatments, with shared antigenbased therapies leading development. The introduction of CRISPR technology is expected to enhance the efficiency and safety of gene-modified therapies, shaping the future of cancer immunotherapy. This review highlights the rapidly advancing field of TCR-T cell therapies and their potential to revolutionize cancer treatment.

Background: Previous studies in Korea have investigated the impact of cardiovascular risk factors on the occurrence of ischemic stroke, but research examining the post-occurrence effects remains scarce. Therefore, we aimed to identify differences in medical costs for patients with ischemic stroke based on the presence or absence of cardiovascular risk factors. Methods: This retrospective cohort study utilized data from the National Health Insurance Service-National Sample Cohort. Patients with ischemic stroke were categorized based on the presence of cardiovascular risk factors—dyslipidemia, hypertension, and type 2 diabetes—to assess differences in total healthcare costs. Analysis included monthly average medical costs during the entire observation period following the first occurrence of ischemic stroke. Additionally, generalized linear modeling was employed to identify factors influencing medical costs and to assess the extent of their impact. Results: A total of 4,176 patients with ischemic stroke were identified, including 703 patients with dyslipidemia, 968 with type 2 diabetes, and 2,123 with hypertension. The monthly medical costs per patient with type 2 diabetes were \830K (thousand), and per patient without type 2 diabetes were \720K. The analysis using generalized linear modeling revealed that patients with diabetes tended to incur approximately 15% higher costs compared to patients without type 2 diabetes. Conclusion: Ischemic stroke patients with type 2 diabetes experienced increased healthcare utilization and costs. Effective management of type 2 diabetes is particularly crucial for patients with ischemic stroke, emphasizing the importance of prevention and management of this condition.

Background: Medication persistence is important in treatment effectiveness for glaucoma patients. This study aims to estimate the persistence of topical glaucoma medication and evaluate the risk of the continuity of care for non-persistence and costs. Methods: This retrospective study analyzed the national health insurance service sample cohort data covering the South Korean population. All patients initiating topical medications from 2011 to 2018 were followed up until 2019. Patients were classified into three groups according to the continuity of care index (COCI): high (COCI=1), medium (1>COCI>0.5), and low (0.5>COCI). Non-persistence was defined as a gap of more than 90 days in refills or a switch/addition of medications. Cox proportional hazard model was used to estimate hazard ratios (HR) of non-persistence, and generalized linear model was used to estimate the cost ratios of COCI and medications. Results: A total of 8062 patients were identified. 21-44% of patients discontinued their first treatment at 1 year, depending on COCI and medications. Prostaglandin analogs (HR=0.71, 95% CI 0.66-0.77) and COCI (low vs. high: 1.49, 1.31-1.59; medium vs. high: 1.23, 1.17-1.29) were associated with the non-persistence. The medium COCI group spent more cost compared to the high group (cost ratio of low vs. high: 0.95, 0.90-0.99; medium vs. high: 1.12, 1.07-1.16). Conclusions: The persistence rate for glaucoma medications in Korea is low, but continuity of care can improve that. High continuity based on solid physician-patient relationships and effective patient education would be essential to nudge patients to stay persistent.

Background: As the profession evolves, pharmacy schools worldwide are recognizing the importance of leadership education, starting at the undergraduate level. This study examined the status of leadership education in international pharmacy programs to propose strategies for effective implementation in Korean pharmacy schools. Methods: Leadership curricula from 34 pharmacy schools across 5 countries (the US, the UK, Canada, Japan, and Australia) were collected from school websites, syllabi, and articles using keywords such as “leadership” or “leader” and analyzed based on course titles, academic years taught, program types (e.g., required, elective, or cocurricular and extracurricular), credits, content, teaching and learning methods, and assessments. Results: Although most pharmacy schools teach pharmacy leadership, objectives, content, teaching methods, and assessment approaches vary. Most programs offer these as elective (50.0%) or required (38.5%) courses, both of which are more common than cocurricular or extracurricular formats (11.6%). The course content often includes leadership theories, competencies, self-development and reflection, organizational management, and global themes. Most courses are 1~2 credits and use various methods, including lectures, discussions, projects, case studies, and guest speakers. Conclusions: The findings identify substantial variation in leadership education across pharmacy curricula. To prepare students to take on leadership roles within the pharmacy profession and face a changing health care system, schools should recognize and raise awareness of the importance of leadership education and ensure their curricula also reflect this. Furthermore, these findings suggest the need to develop a systematic curriculum with practical and experiential learning methods to promote leadership competency.

Background: The authors performed gap analyses on the expedited programs associated with regenerative medicine therapies (RMTs), offered by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS). Methods: The regulations and guidelines on expedited programs (e.g., Regenerative Medicine Advanced Therapy [RMAT] designation) associated with RMTs, and regulatory reviews on approved RMTs were retrieved from the websites of FDA, EMA and MFDS. Based on analyses of the retrieved materials, gap analyses were performed on the qualifying criteria, features and operational frameworks. Included were the comparisons of the expedited programs granted for tisagenlecleucel among the agencies. Results: FDA offers RMAT, Fast Track, Breakthrough Therapy, Priority Review designations, and Accelerated Approval. EMA’s programs include PRIority MEdicines (PRIME), Accelerated Assessment, Exceptional Circumstances, and Conditional Marketing Authorisation. MFDS implements a single Fast-Track Processing program. RMAT designation is specific to RMTs and can be utilized with FDA’s other expedited programs. PRIME applies to all medicinal products and can be used with EMA’s other programs. Fast-Track Processing program is specific to RMTs but combines all expedited features into a single track. Tisagenlecleucel received RMAT, Priority Review and Accelerated Approval for follicular lymphoma from FDA, PRIME for acute lymphocytic leukemia from EMA, and Fast-Track Processing for follicular lymphoma from MFDS. Conclusion: FDA offers the RMAT designation exclusive to expediting the development, review and approval of RMTs in addition to other expedited programs, whereas EMA does RMT approvals under expedited drug approval programs. MFDS implements an exclusive, single-track program for RMTs.

Background: Health literacy influences individuals’ understanding and use of health information, affecting their health behaviors. While research has studied the link between health literacy and behaviors or chronic disease management, fewer studies have focused on its impact on non-prescription products and pharmacy use. This study examines the association between health literacy and community pharmacy use, particularly for over-the-counter (OTC) drugs and supplements. Methods: This cross-sectional study utilized 2021 Korean Health Panel data and conducted analysis between September and October 2024. Out of 10,024 respondents, 8,541 were included. Health literacy was classified into three levels based on respondents’ scores according to prior research: low (inadequate), intermediate (marginal), and high (adequate). Annual spending on OTC drugs and supplements, as well as the primary source of supplements (pharmacy or non-pharmacy), were analyzed. Logistic regression adjusted for sociodemographic and health-related factors. Results: After adjusting for covariates, no significant association was found between health literacy and OTC drug expenditure (low health literacy: aOR 1.067; 95% CI 0.913-1.246, p=0.481). However, lower health literacy was significantly associated with lower spending on supplements (aOR 1.581; 95% CI 1.332-1.876, p<0.001). It also correlated with a higher likelihood of selecting pharmacies for supplements (aOR 1.443; 95% CI 1.172-1.774, p=0.005). Conclusions: Lower health literacy is linked to reduced supplement product spending and a preference for pharmacies as the main source of supplements. Pharmacists play a crucial role in guiding consumers with low health literacy, potentially improving outcomes through targeted support. through targeted support.