MedPath

Clinical Trial News

Lamotrigine Shows Promise as Alternative Treatment for Non-Dystrophic Myotonia in Head-to-Head Trial

  • A randomized, double-blind, crossover trial compared lamotrigine to mexiletine for non-dystrophic myotonia, a rare muscle disorder.
  • Lamotrigine demonstrated similar efficacy to mexiletine in reducing muscle stiffness, the primary symptom of the condition.
  • Lamotrigine offers advantages including better tolerability, use during pregnancy, and lower cost, expanding treatment options.
  • The findings support lamotrigine as a valuable alternative, especially where mexiletine is unsuitable or inaccessible.

Olomorasib Plus Pembrolizumab Shows Promise in KRAS G12C-Mutated NSCLC

  • Olomorasib combined with pembrolizumab demonstrated a 77% overall response rate in first-line NSCLC patients with KRAS G12C mutations, regardless of PD-L1 expression.
  • In previously treated NSCLC patients, the combination therapy achieved a 40% overall response rate and an 88% disease control rate.
  • Common adverse events included diarrhea, fatigue, and increased ALT levels, with manageable safety profiles observed across both cohorts.
  • A global registrational trial, SUNRAY-01 (NCT06119581), is underway to further evaluate the combination in first-line KRAS G12C-mutated NSCLC.

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

NCT06119581RecruitingPhase 3
Eli Lilly and Company
Posted 12/21/2023

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

NCT04956640RecruitingPhase 1
Eli Lilly and Company
Posted 7/19/2021

AbbVie Seeks Accelerated FDA Approval for Telisotuzumab Vedotin in c-Met Overexpressing NSCLC

  • AbbVie has submitted a Biologics License Application (BLA) to the FDA for telisotuzumab vedotin to treat NSCLC with c-Met protein overexpression.
  • The BLA is supported by Phase 2 LUMINOSITY trial data, which showed promising overall response rates in c-Met high and intermediate patients.
  • Telisotuzumab vedotin, an antibody-drug conjugate, targets c-Met-overexpressing tumors and could be a first-in-class therapy if approved.
  • The FDA previously granted Breakthrough Therapy Designation to telisotuzumab vedotin, and a Phase 3 trial is underway to confirm its efficacy.

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT04928846RecruitingPhase 3
AbbVie
Posted 3/25/2022

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

Dietary Factors Show Protective Effects Against IgA Nephropathy in Landmark Mendelian Study

  • A groundbreaking Mendelian randomization study reveals that cheese, cereal, and sushi consumption are associated with decreased risk of IgA nephropathy, offering new preventive dietary strategies.
  • Frequent alcohol consumption significantly increases IgA nephropathy risk, with an odds ratio of 1.267 (95% CI: 1.100-1.460), suggesting potential lifestyle modifications for disease prevention.
  • The study, analyzing data from 477,784 participants, provides the first causal evidence linking dietary choices to IgA nephropathy risk, though findings primarily apply to European populations.

Vitamin D Supplementation Shows No Significant Benefit for COPD Management

  • A Cochrane review of 10 trials found that vitamin D supplementation does not reduce the rate of moderate or severe COPD exacerbations requiring systemic corticosteroids or antibiotics.
  • Vitamin D supplementation likely has no impact on lung function, as measured by FEV1 (% predicted), in COPD patients.
  • The analysis suggests vitamin D has little to no effect on mortality or quality of life in individuals with COPD, based on low-certainty evidence.
  • Current evidence does not support routine vitamin D supplementation for managing COPD symptoms or preventing exacerbations in most patients.

Personalized mRNA Vaccines Show Promise in Colorectal Cancer Treatment and Prevention

• Dr. Victoria Kunene leads trials of personalized mRNA vaccines against colorectal cancer within the NHS Cancer Vaccine Launch Pad initiative. • The vaccines are designed to target unique mutations in a patient's tumor DNA, aiming to prevent cancer recurrence after surgery and chemotherapy. • The approach involves identifying neoantigens to re-educate the immune system, generating specific T-cells against the cancer. • Early phase studies show promising results, with the UK leading recruitment for these trials, offering hope for improved patient outcomes.

Beam Therapeutics Advances Gene Editing Pipeline with Clinical and Manufacturing Milestones

• Beam Therapeutics' BEAM-101, targeting sickle cell disease, has completed dosing in the sentinel cohort of its Phase 1/2 BEACON trial, with initial data expected at the ASH Annual Meeting. • The company's BEAM-302 for Alpha-1 Antitrypsin Deficiency has begun dosing patients in its Phase 1/2 trial, with initial data anticipated in the second half of 2025. • Beam has made advancements in manufacturing, showcasing an automated CD34+ cell process that increases capacity threefold while improving consistency for BEAM-101. • With a strong cash position of $1.1 billion, Beam is financially secure into 2027, enabling continued investment in its research and development programs.

Dyadic Coping Intervention Shows Promise for Stroke Recovery

  • A randomized controlled trial is underway to assess the effectiveness of the Dyadic Coping Intervention of Social Participation (DCISP) for stroke survivors and their spouses.
  • The DCISP aims to improve social participation, quality of life, and dyadic coping strategies through a 3-month intervention involving both the stroke survivor and their spouse.
  • The study will evaluate feasibility, social participation levels, stroke knowledge, caregiver burden, and dyadic coping using validated questionnaires and statistical analysis.
  • Recruitment is ongoing across three tertiary hospitals in Shanghai, with data collection at baseline, 1-month, 3-month, and 6-month follow-up to assess the intervention's impact.

Aquestive Therapeutics Advances Anaphylm and Alopecia Treatment, Receives Analyst Boost

  • Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid symptom resolution in an oral allergy syndrome challenge study, with a median time of 12 minutes.
  • The company plans to hold a pre-NDA meeting with the FDA in Q4 2024 and submit the NDA in Q1 2025, targeting a product launch in Q1 2026.
  • Aquestive is also developing AQST-108, a topical gel for alopecia areata, with a Phase 2 study expected to commence in the second half of 2025.
  • H.C. Wainwright raised the price target for Aquestive Therapeutics to $10, reflecting the potential of Anaphylm and AQST-108.

CEPHEUS Trial Supports Quadruplet Therapy with Daratumumab as New Standard in Multiple Myeloma

  • The CEPHEUS trial suggests that transplant-ineligible multiple myeloma patients may benefit from quadruplet regimens in the frontline setting, leading to deeper responses and improved progression-free survival.
  • The study builds on the MAIA trial, indicating that daratumumab-based quadruplet therapy could surpass previous benchmarks for treating transplant-ineligible patients.
  • VRd (bortezomib, lenalidomide, dexamethasone) was the standard-of-care arm, while the experimental arm added daratumumab, potentially offering enhanced outcomes compared to VRd alone.
  • The CEPHEUS trial results support the use of anti-CD38 monoclonal antibody-based quadruplets for transplant-ineligible or deferred patients, potentially establishing a new standard of care.

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

NCT00644228Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 7/28/2008

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

NCT02874742CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/29/2016

Trending News

1

AbbVie Acquires In Vivo CAR-T Developer Capstan Therapeutics for Up to $2.1 Billion

2 days ago
2

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

2 days ago
3

Klotho Neurosciences Advances Gene Therapy Manufacturing for ALS Treatment

2 days ago
4

FDA Approves Takeda's GAMMAGARD LIQUID ERC, First Ready-to-Use Low IgA Immunoglobulin Therapy for Primary Immunodeficiency

2 days ago
5

Stalicla Secures CHF 2 Million Financing from Addex Therapeutics to Advance Precision Medicine for Autism and Neurodevelopmental Disorders

2 days ago
6

Vetter Breaks Ground on $285 Million Clinical Manufacturing Facility in Illinois

2 days ago
7

Apellis Secures $300 Million in Non-Dilutive Financing Through Sobi Royalty Agreement for Rare Kidney Disease Therapy

a day ago
8

Portal Biotech Secures $35M Series A to Commercialize World's First Full-Length Single-Molecule Protein Sequencer

2 days ago
9

FDA Mandates New Safety Warnings for ADHD Stimulants in Children Under Six

2 days ago
10

China Approves ORPATHYS-TAGRISSO Combination for EGFR-Mutated Lung Cancer with MET Amplification

2 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy