Clinical Trial News

MAIA Biotechnology reports positive Phase 2 trial results for THIO in NSCLC, showing unprecedented disease control rates. The company outlines 2024 milestones, including advancing THIO-101 trial and developing next-gen telomere-targeting agents. THIO, a first-in-class telomere-targeting agent, is in clinical development for NSCLC, with promising efficacy and safety data.

The FDA approved Casgevy, a CRISPR-based therapy by Vertex Pharmaceuticals and CRISPR Therapeutics, for treating transfusion-dependent beta thalassemia, following its approval for sickle cell disease. Casgevy modifies patients' blood cells to increase hemoglobin production, with common side effects including mouth sores and fever. Vertex is establishing treatment centers across the U.S. for its administration.

Nurix Therapeutics' NX-5948, a BTK degrader, received FDA Fast Track designation for treating r/r CLL/SLL after positive Phase 1 data. The drug showed clinical benefits and was well-tolerated in trials, with plans to accelerate enrollment for a pivotal study.

Axicabtagene ciloleucel (axi-cel) shows promise as a second-line therapy for relapsed/refractory large B-cell lymphoma, with a 71% complete metabolic response at 3 months and manageable safety. The phase 2 study highlights its efficacy and safety, with ongoing evaluations of secondary endpoints and quality of life impacts.

A recent international multicenter retrospective cohort study has shed light on the role of adjuvant chemotherapy in treating intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC). The study, involving 1,031 patients from 16 centers, found that adjuvant chemotherapy significantly benefits node-positive patients with elevated or markedly elevated carbohydrate antigen 19-9 (CA19-9) levels, while node-negative patients did not show a significant benefit. The research also highlighted issues of overtreatment and undertreatment in the current practices.

A recent clinical trial has demonstrated that the Houtou Jianweiling Tablet (HTJWT), a traditional Chinese medicine, is both safe and effective for treating mild to moderate symptoms of Chronic Non-atrophic Gastritis (CNAG) in the Pakistani population. The study, conducted as a phase II, double-blind, randomized, parallel-controlled trial, compared the efficacy and safety of HTJWT against Omeprazole, showing comparable results with minimal adverse effects.

Eisai announced the Scientific Advisory Group (SAG) will discuss lecanemab's Marketing Authorisation Application (MAA) in the EU, with a decision expected in Q2 2024. Lecanemab, developed with BioArctic, is a treatment for Alzheimer's, approved in the US, Japan, and China. BioArctic plans to commercialize lecanemab in the Nordic region with Eisai.

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.

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.

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.