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Clinical Trial News

FDA Approves Roche's Injectable Ocrevus, Novartis' Kisqali, and Lilly's Ebglyss; WHO Clears Bavarian Nordic’s Mpox Vaccine

• Roche's Ocrevus gains FDA approval for an injectable version, offering a new administration option for multiple sclerosis patients. • Novartis' Kisqali receives FDA approval to reduce the risk of recurrence in HR+/HER2- early breast cancer, expanding treatment options. • Lilly's Ebglyss (lebrikizumab-lbkz) is approved for moderate-to-severe atopic dermatitis in adults and children 12 years and older. • The World Health Organization clears Bavarian Nordic’s mpox vaccine, marking the first WHO-approved shot for mpox containment.

CHMP Recommends Approval of Henlius and Intas' Serplulimab for ES-SCLC in Europe

  • The CHMP has issued a positive opinion for serplulimab (HETRONIFLY®), recommending its approval in Europe for ES-SCLC treatment.
  • Serplulimab, developed by Henlius and to be commercialized by Intas, is a recombinant humanized anti-PD-1 monoclonal antibody.
  • The recommendation is based on the ASTRUM-005 trial, which showed serplulimab plus chemotherapy improved outcomes in ES-SCLC.
  • If approved, serplulimab will be the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC.

Inavolisib Demonstrates Promising Disease Control in PIK3CA-Mutated Solid Tumors

• Interim results from the CRAFT trial show inavolisib achieved a 36% disease control rate at day 110 in patients with PIK3CA-mutated solid tumors. • The most common adverse event was hyperglycemia, but inavolisib generally exhibited a manageable safety profile in the trial. • The FDA previously granted priority review to inavolisib in combination with palbociclib and fulvestrant for HR+/HER2- breast cancer with PIK3CA mutation. • Further research is ongoing to clarify inavolisib’s efficacy and safety across various disease states and identify potential response predictors.

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

CRAFT: The NCT-PMO-1602 Phase II Trial

NCT04551521CompletedPhase 2
German Cancer Research Center
Posted 10/13/2021

AVMA Veterinary Clinical Trials Registry Highlights New Studies in Canine and Feline Oncology and Neurological Disorders

  • The AVMA Veterinary Clinical Trials Registry lists studies for animal health, connecting researchers with veterinarians and owners.
  • North Carolina State University is exploring a novel treatment approach for oral cancer in cats.
  • Several studies are investigating canine cancers, including hemangiosarcoma, osteosarcoma, and mast cell tumors, with innovative therapies.
  • Research is underway to assess treatments for canine cognitive dysfunction and degenerative myelopathy, mirroring human neurological conditions.

EMA Recommends Approvals for Novel Therapies Targeting Cancer, Hemophilia, and Neurological Disorders

  • The EMA's CHMP recommended ten new medicines for approval, including Alhemo for hemophilia and Wainzua for hereditary transthyretin-mediated amyloidosis.
  • Positive opinions were adopted for two influenza vaccines, Fluad and Flucelvax, and for Siiltibcy, a diagnostic for Mycobacterium tuberculosis infection.
  • CHMP recommended extensions of indication for twelve already authorized medicines, expanding treatment options for various conditions.
  • The committee elected Bruno Sepodes as its new chair and Outi Mäki-Ikola as its new vice-chair, effective September and October 2024, respectively.

Apellis' Syfovre Rejected Again in Europe for Geographic Atrophy

• The European Medicines Agency reaffirmed its rejection of Apellis' Syfovre for treating geographic atrophy, despite the company's efforts to re-evaluate the supporting evidence. • This decision prevents Syfovre from entering the European market, where approximately 2.5 million individuals are affected by geographic atrophy, an irreversible cause of blindness. • The rejection was based on concerns that Syfovre did not demonstrate clinically meaningful benefits and carried significant risks of adverse events with regular injections. • Apellis plans to restructure its European operations and reduce its workforce by about 40 employees following the negative outcome, while awaiting decisions in other regions.

Lamivudine Prophylaxis Shows Promise in Preventing HIV Acquisition in Infants of Mothers with High Viral Load

  • A phase II clinical trial in Burkina Faso evaluated lamivudine prophylaxis in infants born to mothers with HIV and high viral loads.
  • The study found a low rate of new HIV infections in infants receiving lamivudine between 8 weeks and 12 months of age.
  • Lamivudine prophylaxis was initiated based on maternal viral load at the EPI-2 immunization visit, optimizing targeted prevention.
  • The intervention demonstrates a potential strategy to reduce mother-to-child HIV transmission in breastfeeding populations.

Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV

NCT03869944Unknown StatusPhase 2
ANRS, Emerging Infectious Diseases
Posted 12/4/2019

Aligos Therapeutics' ALG-055009 Shows Promise in Phase IIa MASH Trial

• Aligos Therapeutics announced positive results from its Phase IIa HERALD trial of ALG-055009 for MASH, demonstrating notable liver fat reduction. • The trial, involving 102 subjects, showed that doses of ALG-055009 led to up to 70% of subjects experiencing a ≥30% relative decrease in liver fat. • ALG-055009 exhibited a favorable tolerability profile with mainly mild to moderate adverse events and significant decreases in atherogenic lipids. • Aligos is currently evaluating options to fund continued development, with plans to complete activities for a Phase IIb study by mid-2025.

FDA Approvals Surge for Targeted Therapies in Advanced NSCLC

  • The FDA has approved 30 new drugs for advanced non-small cell lung cancer (NSCLC) since 2011, primarily tyrosine kinase inhibitors and immune checkpoint inhibitors.
  • Targeted therapies, particularly small-molecule inhibitors, have shown high overall response rates and durable responses in NSCLC with oncogene driver alterations.
  • Regulatory agencies prioritize survival or event-free survival endpoints in randomized controlled trials for NSCLC without driver alterations.
  • Antibody-drug conjugates, potent biologics linked to cytotoxic compounds, are emerging as a significant class of therapeutics in NSCLC treatment.

Antidepressant Vortioxetine Shows Promise in Treating Glioblastoma in Preclinical Studies

  • Researchers have identified vortioxetine, an FDA-approved antidepressant, as a potential treatment for glioblastoma, an aggressive brain tumor, due to its ability to cross the blood-brain barrier.
  • Preclinical studies in cell cultures and mice demonstrated that vortioxetine effectively suppressed glioblastoma cell growth, especially when combined with standard treatments like chemotherapy and radiation.
  • The research team is preparing for clinical trials to evaluate the efficacy of vortioxetine in human glioblastoma patients, with cautious optimism about its potential to improve treatment outcomes.
  • Experts caution against self-medication with vortioxetine, emphasizing the need for clinical trials to determine appropriate dosages and confirm its effectiveness and safety in humans.

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