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Clinical Trial News

Rheumatoid Arthritis: Macrophage Subtype Identified as Potential Target for Early Diagnosis and Treatment

  • Researchers have identified a dominant macrophage subtype (CD40+CD206+CD163+) in the inflamed rheumatoid arthritis (RA) synovium, associated with disease activity and treatment response.
  • This macrophage subtype is present early in RA development, even before clinical symptoms manifest, suggesting its potential as an early diagnostic biomarker.
  • Targeting the pro-inflammatory responses of these macrophages could offer new therapeutic strategies for RA, especially for patients unresponsive to current treatments.
  • The study highlights the potential of reprogramming macrophages towards resolution of inflammation as a novel therapeutic approach in rheumatoid arthritis.

Outpatient CAR-T Therapy Shows Promise in Treating Relapsed Lymphoma

  • A recent study demonstrates the feasibility and safety of administering CAR-T therapy on an outpatient basis for patients with relapsed or refractory large B-cell lymphoma.
  • The OUTREACH study found that 70% of participants received CAR-T therapy as outpatients, with a quarter of those never requiring hospitalization, showcasing improved accessibility.
  • Lisocabtagene maraleucel (liso-cel) was used due to its lower risk of side effects, with efficacy in line with previous trials, showing an 80% objective response rate.
  • The findings suggest that community medical centers can effectively administer CAR-T therapy, potentially expanding access and improving outcomes for lymphoma patients.

Deucravacitinib Demonstrates Efficacy for Scalp and Overall Psoriasis in Phase 3 and Real-World Studies

  • Deucravacitinib shows sustained efficacy and a consistent safety profile in treating moderate to severe psoriasis for up to six months, according to phase 3 trial data.
  • The PSORIATYK SCALP trial demonstrated that nearly half of deucravacitinib-treated patients achieved significant scalp psoriasis improvement compared to placebo at week 16.
  • Real-world data from the RePhlect registry supports the clinical trial findings, indicating that dermatologists can expect similar efficacy in routine practice.
  • The oral convenience of deucravacitinib offers a valuable treatment option, especially for patients who find scalp psoriasis challenging to manage with topical therapies.

Route 66 SPORE Grant to Study Non-Surgical Treatments for Uterine Cancer

  • The UNM Cancer Center is launching a clinical trial as part of the Route 66 SPORE grant to explore non-surgical treatments for uterine cancer, aiming to preserve fertility in younger women.
  • The trial seeks to identify biomarkers that predict response to hormone therapy, potentially allowing doctors to personalize treatment approaches for women with early-stage uterine cancer.
  • The study will also investigate the impact of intensive exercise and diet control on uterine cancer treatment outcomes, integrating lifestyle interventions into the therapeutic strategy.
  • The Route 66 SPORE projects will involve over 100 women across three institutions, with a three-year follow-up to assess the long-term efficacy of non-surgical interventions.

Bristol Myers Squibb Prevails in $6.4 Billion Lawsuit Over Breyanzi Approval Delay

  • Bristol Myers Squibb (BMS) secured dismissal of a $6.4 billion lawsuit alleging delayed FDA approval of Breyanzi and other Celgene-developed drugs.
  • The U.S. District Judge cited improper appointment of UMB Bank as trustee for contingent value rights (CVR) holders as the reason for dismissal.
  • CVR holders claimed BMS deliberately slowed submissions to the FDA to avoid a $6.4 billion payout tied to drug approval milestones.
  • Despite the lawsuit, Breyanzi received FDA approval on February 5, 2021, for treating non-Hodgkin’s lymphoma.

FDA Clears Pi-Cardia's ShortCut Device for Valve-in-Valve TAVR Procedures

• Pi-Cardia's ShortCut device receives FDA clearance to reduce coronary obstruction risk during valve-in-valve transcatheter aortic valve replacement (TAVR). • The ShortCut device mechanically splits aortic valve leaflets before valve placement, differing from electrosurgery-based methods like the BASILICA procedure. • Clinical data demonstrated ShortCut's safety and effectiveness in leaflet splitting, making it a teachable step in TAVR to safely treat patients at risk of coronary obstruction. • Pi-Cardia plans a limited commercial launch of ShortCut, with future expansions potentially covering 30% of TAVR cases requiring leaflet modification.

Walden Biosciences Completes Enrollment in Phase 2 Trial of WAL0921 for Chronic Kidney Diseases

  • Walden Biosciences has completed initial dosing in the first cohort of its Phase 2 basket study evaluating WAL0921 for chronic kidney diseases.
  • The Phase 2 study is designed to assess the safety and efficacy of WAL0921 in patients with diabetic nephropathy and rare glomerular kidney diseases.
  • Topline data from the first cohort of the multiple ascending dose study is expected by the end of 2024, with rare kidney disease cohorts to follow in early 2025.
  • WAL0921 is a first-in-class monoclonal antibody targeting soluble urokinase plasminogen activator receptor (suPAR) to treat podocyte dysfunction.

Endostar Continuous Infusion Enhances Chemoradiotherapy Efficacy in Esophageal Cancer

  • A study of 62 patients with esophageal squamous cell carcinoma (OSCC) showed that Endostar continuous infusion significantly improved treatment outcomes.
  • The objective response rate (ORR) was highest in the Endostar continuous infusion group (100%) compared to intravenous drip (95.2%) and chemoradiotherapy alone (78.6%).
  • Continuous Endostar infusion also resulted in higher progression-free survival rates compared to concurrent chemoradiotherapy, indicating improved long-term efficacy.
  • The study suggests that continuous Endostar infusion alongside chemoradiotherapy is a safe and effective treatment strategy for OSCC, enhancing both short- and long-term results.

ESMO Congress Highlights Immunotherapy Advancements in Multiple Cancers

  • KEYNOTE-522 update confirms that perioperative pembrolizumab with neoadjuvant chemotherapy improves overall survival (OS) in stage II-III triple-negative breast cancer patients.
  • NIAGARA trial shows perioperative durvalumab with neoadjuvant chemotherapy improves event-free survival (EFS) and OS in cisplatin-eligible patients with muscle-invasive bladder cancer.
  • ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial indicates that adding pembrolizumab to chemoradiotherapy enhances OS in locally advanced cervical cancer patients.
  • LEAP-012 trial reveals that pembrolizumab and lenvatinib with transarterial chemoembolization significantly improves PFS in intermediate-stage hepatocellular carcinoma.

Hypofractionated Radiotherapy Shows Similar Quality of Life Outcomes in Intermediate-Risk Prostate Cancer

  • A randomized trial of 1,206 intermediate-risk prostate cancer patients compared moderate hypofractionation to conventional fractionation radiotherapy.
  • No significant differences were observed in urinary, sexual, or hormonal quality of life scores between the two radiotherapy approaches at 24 and 48 months.
  • Bowel summary scores favored conventional fractionation at 48 months, but overall, hypofractionation showed comparable health-related quality of life.
  • The study supports moderate hypofractionation as a standard of care option, considering efficacy, toxicity, convenience, and quality of life.
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