Clinical Trial News

The MARIPOSA trial showed amivantamab-vmjw plus lazertinib significantly improves progression-free survival over osimertinib in EGFR-mutated NSCLC patients, with a trend toward better overall survival. Safety profiles were consistent with prior data, highlighting the combination's potential as a new standard of care.

V-safe and VAERS systems monitor RSV vaccine reactions in U.S. adults ≥60 years. From May 3, 2023–April 14, 2024, 16,220 V-safe participants reported symptoms post-vaccination, with 39.0% possibly related to RSV vaccination. VAERS received 3,200 adverse event reports, 8.8% serious, including 34 deaths. GBS cases were noted post-GSK and Pfizer vaccines.

FDA approves Arcutis' Zoryve (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis in adults and children from 6 years old, offering a once-daily, steroid-free option with rapid disease clearance and significant itch reduction.

Elevar Therapeutics will resubmit an NDA for rivoceranib plus camrelizumab for unresectable HCC treatment after FDA's CRL cited manufacturing issues, not clinical data. The CARES-310 trial showed significant OS and PFS improvements over sorafenib, with a median OS of 23.8 months for the combination therapy.

Interius BioTherapeutics received HREC approval and CTN clearance to start a Phase 1 trial for INT2104, a novel in vivo CAR therapy targeting B cell malignancies, in 4Q24. INT2104, an off-the-shelf, single-dose treatment, aims to create CAR-T and CAR-NK cells in vivo without preconditioning.

NeuroSense Therapeutics reports positive 12-month results from its PARADIGM Phase 2b study of PrimeC in ALS patients, showing significant improvements in complication-free survival and disease progression. The company plans to submit these findings to the FDA and other regulatory agencies to discuss PrimeC's future development. PrimeC demonstrated a 57% to 73% improvement over placebo in various measures, highlighting its potential as an effective ALS treatment.

FDA approves Genentech's Vabysmo Prefilled Syringe (PFS) for wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO), affecting nearly 3 million people in the U.S. Vabysmo PFS, a bispecific antibody, offers a ready-to-use format, enhancing treatment simplicity and effectiveness.

Annovis Bio's share price surged 100% after positive Phase III trial results for buntanetap in Parkinson's disease, showing improved cognition. The trial involved 523 patients, with significant improvements in MDS-UPDRS scores for those diagnosed over three years ago and with PIGD. Despite a setback in Alzheimer's trial, Annovis plans a Phase III trial.

FDA approves Kisunla (donanemab-azbt) for early symptomatic Alzheimer's disease, targeting amyloid plaques. Kisunla, a once-monthly IV infusion, shows potential to stop therapy upon plaque removal, reducing costs and infusions. Clinical trials demonstrate significant slowing of clinical decline and amyloid plaque reduction, though risks include amyloid-related imaging abnormalities (ARIA) and infusion-related reactions.

FDA issued a draft guidance on Diversity Action Plans to improve enrollment of underrepresented populations in clinical studies, required under FDORA 2022. The plans aim to increase representation based on race, ethnicity, sex, and age, and must specify enrollment goals and strategies. Comments on the draft are due by September 26, 2024.