Clinical Trial News

TNT, adopted as standard care for LARC, shows improved outcomes over traditional treatments, including longer DFS and MFS, higher pCR rates, and reduced distant metastases. Studies like UNICANCER-PRODIGE 23 and RAPIDO highlight TNT's benefits, though questions remain on the impact of adjuvant chemotherapy. TNT's effectiveness varies, with some studies showing no significant differences in outcomes.

Telix's Group Chief Medical Officer, Dr Colin Hayward, highlights the milestone of dosing the first patient in the ProstACT GLOBAL study, emphasizing its potential to enhance data on TLX591. This study explores a first-in-class rADC candidate's benefits with standard care, thanking the clinical team and participating patients.

The EMA approved Uzpurvo, the first biosimilar to Stelara (ustekinumab), for Crohn disease, psoriatic arthritis, and plaque psoriasis. Developed by Alvotech and marketed by STADA, it aims to expand patient access post-July 2024. Uzpurvo targets IL-12 and IL-23 cytokines, offering a cost-effective treatment option.

Glucarpidase treatment in HDMTX-AKI patients showed higher kidney recovery odds, reduced mortality, and faster recovery from neutropenia and liver enzyme normalization compared to non-treated patients. The study, the largest on HDMTX-AKI, supports early glucarpidase use, especially within the first 60 hours and in severe AKI cases.

The FDA accepted an NDA for SH-105, a ready-to-dilute treatment for breast or ovary adenocarcinoma, with a PDUFA target date of June 24, 2024. This formulation simplifies administration, improving efficiency and safety. Shorla Oncology also develops other cancer treatments, including SH-110 for glioma and SH-201 for various cancers, planning an NDA submission for SH-201 in Q1.

A comprehensive study evaluating the benefit-harm balance of GLP-1 receptor agonists (RAs) for weight loss in individuals with overweight and obesity but without diabetes has found that these drugs can offer significant weight loss benefits, especially when aiming for a 10% reduction in body weight. However, the net benefit is highly dependent on individual treatment goals and tolerance for potential harms.

A study evaluates the effectiveness of the Continuing Precision Medicine (CPM) mobile application in reducing opioid misuse among women post-cesarean section, showing significant reductions in misuse and suggesting more appropriate prescription sizes.

Recent studies highlight the effectiveness of Doxycycline Post-Exposure Prophylaxis (doxy-PEP) in reducing Chlamydia trachomatis and Treponema pallidum infections among men who have sex with men (MSM), though questions remain about its efficacy against Neisseria gonorrhoeae and among cisgender women.

At the 2024 ESMO Congress, Disitamab Vedotin, combined with a PD-1 inhibitor, demonstrated significant efficacy and manageable safety profiles as a first-line treatment for advanced urothelial carcinoma, with a median overall survival of 33.1 months, surpassing traditional chemotherapy outcomes.

Biogen and Eisai's Alzheimer's drug Leqembi received full FDA approval, enabling broader Medicare coverage. Novavax's stock surged after amending its vaccine deal with Canada, involving a $349.6M payment. Caribou Biosciences gained from Pfizer's $25M investment, advancing its CAR-T cell therapy. Prothena secured a $55M deal with Bristol Myers Squibb for Alzheimer's treatment rights.