Clinical Trial News

Diana Burgess, PhD, presents results of the Learning to Apply Mindfulness to Pain (LAMP) multisite, pragmatic clinical trial, comparing two methods.

The Stop-or-Not Trial found no significant difference in death and major complications at 28 days after noncardiac surgery between continuing and discontinuing renin-angiotensin system (RAS) inhibitor therapy, suggesting both strategies are acceptable. Clinicians should manage RAS inhibitor therapy based on individual patient factors and surgery specifics.

Linvoseltamab, a BCMA bispecific antibody, showed efficacy in relapsed/refractory multiple myeloma with an objective response rate of 70.9%, but requires aggressive supportive care to manage high infection risks, especially in communities without clinical trial experience. The importance of supportive care, including intravenous immunoglobulin, and potentially reducing dosing frequency to mitigate infection risks, was emphasized.

The FDA has granted priority review to SpringWorks Therapeutics' NDA for mirdametinib, an investigational MEK inhibitor for treating NF1-PN. The European Medicines Agency also validated the MAA for the same indication. Data from the ReNeu trial showed significant reductions in PN volume and improvements in pain and quality of life. SpringWorks anticipates potential launch in early 2025.

Clinical trials of prucalopride tablets for CIC involved 2530 patients, showing common adverse reactions like headache (19%), abdominal pain (16%), and nausea (14%). Diarrhea onset was early, resolving quickly. Discontinuation due to adverse reactions was 5% for prucalopride vs. 3% for placebo. Cardiovascular safety analysis showed no significant MACE risk increase.

A two-armed school-based cluster randomized controlled trial (CRCT) in 16 primary schools in Morogoro, Tanzania, aims to assess the impact of a school-based training intervention (ICC-T for teachers, ICC-P for parents) on reducing violence in schools and homes. The study includes a baseline assessment before intervention allocation and a follow-up assessment three months after intervention delivery. The intervention, consisting of a five-day training for teachers and a three-weekend-day training followed by a refresher day for parents, focuses on non-violent interaction strategies. The study also includes a process evaluation to monitor fidelity, acceptability, and feasibility of the intervention, and collects both quantitative and qualitative data to assess outcomes such as violence reduction, attitudes towards violence, children's mental health, and school climate.

The ECOG-ACRIN EA2174 trial did not show improved pathologic complete response (pCR) rates with nivolumab added to neoadjuvant chemoradiation for locoregional esophageal and gastroesophageal junction adenocarcinoma, compared to chemoradiation alone. The pCR rates were 24.8% with nivolumab vs 21.0% without, not statistically significant. No additional toxicity was observed, and dropout rates after surgery were high in both arms, suggesting the need for improved trial designs.

VP-315, an oncolytic peptide, showed promising results in reducing tumor size in basal cell carcinoma patients, with 86% experiencing tumor reduction and 51% achieving complete histological clearance. No dose-limiting toxicities were reported, and the agent is being explored as a non-surgical treatment option.

At the ESC conference, Thomas Hauser presented results showing Novartis's XXB750, a natriuretic peptide receptor A agonist, is safe and well tolerated in chronic stable HF patients with reduced or mildly reduced EF, administered subcutaneously. The study supports monthly dosing, with mild adverse events observed.

Dr. Atsushi Tanaka presented the Premier study findings at ESC, showing sacubitril/valsartan (Sac/Val) prompts greater N-terminal pro-brain natriuretic peptide reduction in Japanese acute HF patients without increased adverse events. Key opinion leaders emphasize Sac/Val's use in hospitalized HF patients, considering its revolutionary impact in reducing cardiovascular deaths and hospitalizations. Launched as Entresto in 2015, Sac/Val's efficacy in acute HF management represents a significant opportunity.