Clinical Trial News

Imfinzi approved in the US for treating resectable non-small cell lung cancer before and after surgery, based on the AEGEAN trial showing a 32% reduction in risk of recurrence.

The FDA accepted a priority review for Deciphera's vimseltinib NDA for treating TGCT, with a PDUFA goal date of Feb 17, 2025. Vimseltinib, a CSF1R inhibitor, showed significant efficacy in the Phase 3 MOTION study, presenting an ORR of 40% vs 0% with placebo. The EMA also started its review process for vimseltinib in mid-July.

Pfizer and BioNTech announce Phase 3 trial results for their mRNA-based combination vaccine against influenza and COVID-19 in adults 18-64, with one immunogenicity objective met. A separate Phase 2 trial showed robust immunogenicity for standalone influenza mRNA vaccines. The companies are evaluating adjustments to improve immune responses against influenza B and will discuss next steps with health authorities.

Vericel announces FDA approval of NexoBrid for pediatric severe thermal burns, offering a non-surgical eschar removal solution.

Tecovirimat did not improve clade I mpox resolution in DRC, but showed safe use and lower mortality. Ongoing trials like PALM007 and STOMP aim to develop effective mpox interventions.

Prota Therapeutics' long-term peanut allergy study published in Allergy confirms clinical remission as the optimal treatment outcome, with high-dose oral immunotherapies PRT120 and PRT100 showing lasting benefits, including improved quality of life and reduced allergic reactions.

Tempest Therapeutics announces positive FDA feedback for amezalpat (TPST-1120) in treating first-line hepatocellular carcinoma, with agreement on Phase 3 study design and endpoints.

FDA approves Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior therapies in adult and pediatric patients weighing at least 40 kg.

FDA grants accelerated approval for Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC) in adults, either with ursodeoxycholic acid (UDCA) for inadequate response or as monotherapy for those unable to tolerate UDCA. The approval is based on a Phase 3 study showing 62% of Livdelzi-treated participants achieved a composite biochemical response at month 12, compared to 20% on placebo. Livdelzi led to ALP normalization in 25% of participants, a significant reduction in pruritus, and no treatment-related serious adverse events.

A new approach to cancer therapy involves stressing tumor cells with an activator, LB-100, then eliminating them with a WEE1 inhibitor, adavosertib. This 'paradoxical intervention' worked well in mice and is set for a phase 1b clinical trial for advanced colorectal cancer.