VANDERBILT UNIVERSITY MEDICAL CENTER

At the October 3 Nashville Institute for Value-Based Medicine event, Travis Osterman presented on leveraging AI for precision immunotherapy, focusing on predicting patient responses and toxicities. His project, a collaboration between Vanderbilt University Medical Center and GE Healthcare, aims to use existing patient data for widespread implementation. The project's outcomes, published in the Journal of Clinical Oncology, showed potential to improve clinical trial efficiency and patient outcomes by identifying optimal candidates for treatments and reducing toxicity risks.

GLP-1 obesity drugs may protect kidneys and reduce kidney disease progression, according to a Vanderbilt University Medical Center study published in JAMA Network Open. The study, part of the Million Veteran Program, found higher GLP1R gene expression linked to lower risk of kidney disease progression, suggesting broader kidney-protective effects of GLP-1 receptor agonists beyond diabetes. Further clinical studies are needed to validate this potential across diverse patient groups.

A study by Vanderbilt University Medical Center and Duke Clinical Research Institute found that montelukast, commonly used to prevent asthma attacks, does not speed recovery from mild to moderate COVID-19 symptoms. The randomized trial, part of the NIH ACTIV-6 platform, involved 1,250 outpatients and found no difference in recovery times between montelukast and placebo groups.

CDC recommends extra COVID vaccine doses for those 65+ and immunocompromised, with flexibility for doctors to decide additional doses based on individual needs, aiming to protect against severe infections.

A study coordinated by Vanderbilt University Medical Center and Duke Clinical Research Institute found that montelukast, commonly used to prevent asthma attacks, does not speed recovery from mild to moderate COVID-19 symptoms. The randomized controlled trial involving 1,250 outpatients published in JAMA Network Open showed no difference in recovery time between montelukast and placebo groups. The findings highlight the ongoing challenge of identifying effective outpatient COVID-19 therapies.

Alan Tan, MD discusses the complexities of choosing immuno-oncology (IO)–based treatment regimens for renal cell carcinoma (RCC), highlighting the 8-year follow-up data from the CheckMate 214 trial showing nivolumab plus ipilimumab's median overall survival of 52.7 months vs 37.8 months with sunitinib. He notes the FDA approval of pembrolizumab plus lenvatinib based on the CLEAR trial, and the ongoing questions regarding the use of IO-TKI regimens. Tan emphasizes the need for future research to combat resistance to immune checkpoint inhibition and the importance of symptom burden in treatment decisions.

Underrepresentation of women in cardiovascular clinical trials has led to gaps in understanding sex-based differences in heart disease, affecting diagnosis, treatment, and outcomes. Women often experience different symptoms and delays in seeking care, leading to poorer outcomes. Efforts like Vanderbilt's Women's Heart Center aim to bridge this gap through multidisciplinary care, telehealth, and tailored research, but more nationwide initiatives are needed.

A surge in whooping cough cases, linked to missed vaccinations during COVID-19, highlights the importance of routine immunizations. Infants are most at risk, but the disease can affect all ages. Vaccination, including DTaP or Tdap, is crucial but protection wanes over time, necessitating regular updates.

Women have been underrepresented in cardiovascular clinical trials due to historical misconceptions and FDA guidelines discouraging their participation. Despite efforts since the 1990s, including NIH mandates, women remain underrepresented in heart failure trials, affecting the generalizability of findings. Factors like access, awareness, and comfort with the trial process contribute to lower participation rates. Addressing these barriers requires comprehensive strategies to ensure gender equity in clinical research.

MVA-BN vaccine showed similar immune response in adolescents and adults with no safety issues in a U.S. phase 2 trial. The vaccine, marketed as Jynneos in the U.S. and Imvanex in Europe, is now approved for adolescents. The WHO has prequalified the vaccine for use in high-risk groups, including infants and pregnant women. Bavarian Nordic plans to trial the vaccine in children aged 2 to 12, and CEPI is funding studies on post-exposure vaccination efficacy.