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Fecal Microbiota Transplant Enhances Immunotherapy Response in Metastatic Renal Cell Carcinoma

  • The TACITO-II trial demonstrated that fecal microbiota transplantation (FMT) significantly improves the one-year progression-free survival (PFS) rate in patients with metastatic renal cell carcinoma (RCC).
  • Combining FMT with pembrolizumab and axitinib resulted in a one-year PFS rate of 66.7%, compared to 35% with pembrolizumab and axitinib alone, meeting the trial's primary endpoint.
  • FMT was well-tolerated, with no adverse events related to the transplantation procedure and no increase in severe adverse events associated with pembrolizumab and axitinib.
  • The study suggests that FMT can transfer immune response and enhance the efficacy of immunotherapy in RCC, warranting further investigation into microbiome-based therapeutic strategies.

IMFINZI Regimen Demonstrates 25% Reduction in Death Risk in Bladder Cancer Trial

  • AstraZeneca's IMFINZI (durvalumab) combined with chemotherapy significantly improved event-free survival (EFS) and overall survival (OS) in the NIAGARA Phase III trial for muscle-invasive bladder cancer.
  • The IMFINZI perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared to chemotherapy alone.
  • Patients treated with the IMFINZI regimen experienced a 25% reduction in the risk of death versus neoadjuvant chemotherapy with radical cystectomy.
  • At two years, an estimated 82.2% of patients on the IMFINZI regimen were alive, compared to 75.2% in the chemotherapy-only arm.

FDA Approves Dupixent for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

  • The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This marks the first biologic specifically indicated for adolescent CRSwNP patients, offering an alternative to standard treatments like systemic steroids and surgery.
  • The approval is supported by data from adult trials showing significant improvements in nasal congestion, polyp size, and sense of smell with Dupixent compared to placebo.
  • Dupixent, developed by Regeneron and Sanofi, inhibits the IL-4 and IL-13 pathways, key drivers of type 2 inflammation in CRSwNP.

FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Ebglyss (lebrikizumab-lbkz) for adults and children 12+ with moderate-to-severe atopic dermatitis not controlled by topical treatments.
  • Clinical trials showed significant skin clearance as early as four weeks and itch relief as early as two weeks with Ebglyss treatment.
  • Ebglyss offers long-lasting efficacy, with many patients maintaining results for one year with a monthly maintenance dose.
  • Ebglyss, a targeted IL-13 inhibitor, provides a new first-line biologic option for those whose eczema is not adequately managed by topicals.

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

NCT04178967CompletedPhase 3
Eli Lilly and Company
Posted 10/29/2019

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

NCT04250337CompletedPhase 3
Eli Lilly and Company
Posted 2/3/2020

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

NCT04146363CompletedPhase 3
Eli Lilly and Company
Posted 9/24/2019

TORL-1-23 Shows Promising Activity in CLDN6-Positive Advanced Solid Tumors

  • TORL-1-23, a CLDN6-targeted antibody-drug conjugate, demonstrates encouraging responses in heavily pretreated patients with advanced solid tumors, including platinum-resistant ovarian cancer.
  • The overall response rate reached 42% at a 2.4 mg/kg dose, with durable and deep responses observed, particularly in ovarian cancer patients treated at 2.4 mg/kg and 3.0 mg/kg.
  • The antibody-drug conjugate was well-tolerated, with manageable safety profiles, and the risk of neutropenia was mitigated by prophylactic pegfilgrastim administration.
  • A registrational phase 2 study is planned for CLDN6-positive platinum-resistant ovarian cancer, with further evaluation in other CLDN6-positive cancers, including NSCLC.

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

NCT05103683RecruitingPhase 1
TORL Biotherapeutics, LLC
Posted 11/17/2021

Dupilumab Confirmed Effective for Biologic-Naive Chronic Spontaneous Urticaria in LIBERTY-CUPID Study C

  • Dupilumab significantly reduced itch severity in patients with uncontrolled chronic spontaneous urticaria (CSU) in the LIBERTY-CUPID Study C, showing an 8.64-point reduction compared to placebo.
  • The study also demonstrated a 15.86-point reduction in urticaria activity severity with dupilumab, versus an 11.21-point reduction with placebo, highlighting its impact on disease activity.
  • A significantly higher percentage of patients treated with dupilumab achieved complete response (30%) compared to the placebo group (18%), indicating a potential for substantial relief.
  • Safety results were consistent with the known profile of dupilumab, reinforcing its potential as a valuable treatment option for CSU patients who do not respond to antihistamines.

ESMO Highlights: Imfinzi's Bladder Cancer Success, Keytruda/Lenvima Combo for Liver Cancer, and Opdualag's Lung Cancer Challenge

  • AstraZeneca's Imfinzi demonstrated a 25% reduction in mortality risk for bladder cancer patients when administered before and after surgery, showing a significant clinical benefit.
  • Merck and Eisai's combination of Keytruda and Lenvima, when added to standard care for liver cancer, improved progression-free survival to 14.6 months compared to 10 months with standard care alone.
  • Bristol Myers Squibb's Opdualag faces scrutiny in lung cancer treatment due to concerns over trial design and the modest progression-free survival benefit observed in a specific subgroup.

Systems Thinking Approach Could Revolutionize Clinical Trial Success Rates

  • Less than 15% of promising drug candidates successfully progress from early-phase trials to regulatory approval, highlighting the critical need for improved clinical trial methodologies.
  • A systems thinking approach emphasizing scientific integrity, operational feasibility, and scalability could significantly enhance clinical trial outcomes through holistic stakeholder engagement.
  • Early involvement of diverse stakeholders, including patients, caregivers, KOLs, and payers, helps optimize trial design and ensures better real-world treatment accessibility.

ICH Updates Guidelines: NGS Becomes New Standard for Viral Safety Testing in Biotech Manufacturing

  • The International Council for Harmonisation (ICH) has published Q5A(R2) guidelines, recommending Next-Generation Sequencing as the preferred method for viral safety evaluation in biotechnology products.
  • NGS technology offers superior versatility, speed, and sensitivity for detecting viral contamination, evaluating vector integrity, and monitoring host genome effects in manufactured biotech products.
  • Regulatory compliance now requires validated computer systems with secure audit trails, as outlined in FDA's 21 CFR Part 11, driving the need for specialized NGS data management solutions.

CAR T-Cell Therapy Expands Beyond Cancer: New Frontiers in Autoimmune Disease Treatment

  • CAR T-cell therapy, historically successful in treating blood cancers, is now being adapted for solid tumors and autoimmune conditions like Multiple Sclerosis and Systemic Lupus Erythematosus.
  • Clinical trials for non-oncology CAR T applications require complex coordination between specialty clinics and established oncology infrastructure, necessitating enhanced safety protocols and medical oversight.
  • Worldwide Clinical Trials is implementing comprehensive patient safety measures, including 24/7 medical monitoring and specialized training programs, to support the expansion of CAR T therapy into new therapeutic areas.

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