Clinical Trial News

Pipeline Watch provides a weekly overview of selected late-stage clinical trial updates from pharmaceutical and biotech companies, shared at conferences, in presentations, and through official releases.

Clinical trials often exclude patients with comorbidities, limiting access to investigational therapies. A study led by Dr. Montalban Bravo explored treating 'unfit' AML and MDS patients with azacitidine and vorinostat, showing feasibility and clinical benefit. Results suggest relaxing exclusion criteria could expand trial access and benefit patients with poor prognoses.

Landiolol, an ultra-short acting β1-blocker, effectively reduces heart rate in atrial fibrillation without significant blood pressure drop. It shows higher cardioselectivity and potency than esmolol, with similar pharmacokinetics in Caucasian and Asian populations. Clinical trials confirm its efficacy and safety in emergency settings.

PMV Pharma leads with rezatapopt, a p53(Y220C) stabilizer, targeting a common cancer mutation. Early clinical results indicate potential in treating various solid tumors by restoring p53 function.

A randomized controlled trial comparing internal and external cooling methods for post-cardiac arrest patients found that internal cooling provides tighter temperature control and potentially better survival-to-hospital discharge outcomes, with fewer cardiac arrhythmia complications compared to normothermia.

GSK2857916, an anti-BCMA monoclonal antibody-drug conjugate, received PRIME and Breakthrough Therapy Designations for treating relapsed/refractory multiple myeloma. It also has orphan drug status from EMA and FDA. GSK plans to advance clinical trials, highlighting its potential to transform myeloma treatment.

The Traumatic Brain Injury Endpoints Development (TED) Initiative, funded by the Department of Defense, aims to improve clinical trials for TBI by developing precise diagnostic tools and effective treatments. Over its first 18 months, TED has made significant progress, including engaging with the FDA, creating a comprehensive metadataset, and advancing biomarker and clinical outcome assessment validation.

A study reveals that Ibrutinib, a Bruton tyrosine kinase inhibitor, has shown significant efficacy in treating chronic graft-versus-host disease (cGVHD) in patients who have failed corticosteroid therapy, with a high rate of sustained responses and acceptable safety profile.

The triple combination of atezolizumab, bevacizumab, and GEMOX shows promise for advanced biliary tract cancer (BTC) patients, with a 76.7% ORR and 90.0% DCR. ALS2CL mutations may predict therapy efficacy. Common TRAEs include fever and neutropenia. This regimen offers a potential new treatment avenue for advanced BTC.

The FDA has fully approved blinatumomab (Blincyto) for treating adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), regardless of Philadelphia chromosome status. This approval is based on data from the phase III TOWER study, showing improved overall survival rates compared to standard chemotherapy.