MedPath

Clinical Trial News

Tpoxx Treatment for Mpox Shows Mixed Outcomes, Raises Questions About Efficacy

  • A CDC analysis of over 7,100 mpox patients treated with tecovirimat (Tpoxx) revealed that serious adverse events and deaths were mainly observed in individuals with weakened immune systems.
  • The study, published in NEJM Evidence, highlights the need for caution, as the data couldn't definitively establish tecovirimat's safety and effectiveness against mpox.
  • Most patients received tecovirimat for lesions in sensitive areas like the anogenital region and for pain, with a significant portion also having HIV, suggesting potential implications for immunocompromised individuals.
  • Researchers emphasize the necessity of controlled clinical trials to determine the appropriate use of tecovirimat in treating mpox, especially given the limitations of the expanded-access data.

FDA Approves Biotronik's Selectra 3D Catheter and Solia S Lead for Left Bundle Branch Area Pacing

  • The FDA has granted approval for Biotronik's Selectra 3D catheter, used with the Solia S lead, for left bundle branch area pacing (LBBAP).
  • This marks the first FDA-approved stylet-driven lead and dedicated delivery catheter system for LBBAP, offering a new option for cardiac pacing.
  • The BIO-CONDUCT trial demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate at 3 months with the Solia S lead in LBBAP.
  • The Solia S lead offers advantages over previous LBBAP leads, including continuous pacing off the stylet during implantation.

Mirvetuximab Soravtansine Shows Promise in Platinum-Sensitive Ovarian Cancer

  • Mirvetuximab soravtansine (MIRV) demonstrates a 51.9% overall response rate in patients with platinum-sensitive ovarian cancer (PROC) in the PICCOLO trial.
  • The treatment showed efficacy even in patients who had previously progressed on PARP inhibitors, offering a new option for this difficult-to-treat population.
  • Common side effects of MIRV, including neurosensory issues and gastrointestinal problems, were generally mild and resolved over time.
  • MIRV, an antibody-drug conjugate targeting folate receptor alpha, received FDA approval in 2023 and is under evaluation for approval in Europe.

AMG 193 Shows Promising Activity in MTAP-Deleted Solid Tumors

  • AMG 193, a novel MTA-cooperative PRMT5 inhibitor, demonstrates preliminary clinical activity in patients with MTAP-deleted solid tumors, offering a new targeted therapeutic approach.
  • Early results from a phase 1 trial show confirmed and unconfirmed partial responses across various tumor types, including NSCLC, pancreatic, and biliary tract cancers.
  • The treatment exhibits an acceptable safety profile with manageable adverse events, and no clinically significant myelosuppression was observed in the study.
  • Ongoing trials are exploring AMG 193 in combination with other therapies to further enhance its efficacy in MTAP-deleted solid tumors.

AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

NCT06333951RecruitingPhase 1
Amgen
Posted 9/17/2024

A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion

NCT06360354RecruitingPhase 1
Amgen
Posted 5/29/2024

A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

NCT05094336RecruitingPhase 1
Amgen
Posted 2/1/2022

A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

NCT05975073Active, Not RecruitingPhase 1
Amgen
Posted 8/1/2023

Trastuzumab Deruxtecan Shows Efficacy in HER2-Positive Breast Cancer Brain Metastases

  • Trastuzumab deruxtecan (T-DXd) demonstrates significant activity against HER2-positive breast cancer that has metastasized to the brain, according to the DESTINY-Breast 12 trial.
  • The trial showed a median progression-free survival of 17.3 months in patients with brain metastases, with a 12-month PFS rate of 61.6%.
  • Intracranial objective response, defined as a measurable decrease in cancer in the central nervous system, was observed in 71% of participants.
  • Treatment with T-DXd resulted in a 90% one-year survival rate among patients with and without brain metastases, with manageable side effects.

FDA Approves Apple Watch Feature for Sleep Apnea Detection

  • The FDA has approved Apple's Sleep Apnea Notification Feature (SANF) for the Apple Watch, enabling over-the-counter risk assessment of sleep apnea.
  • The sleep apnea detection feature will be available on Apple Watch Series 9, Series 10, and Ultra 2 via a software update in over 150 countries.
  • The Apple Watch uses its accelerometer to detect breathing disturbances and notifies users of potential moderate to severe sleep apnea based on 30-day analysis.
  • Sleep apnea, affecting over a billion people globally, often goes undiagnosed due to the cost and accessibility of traditional sleep studies.

FDA Grants Fast Track Designation to MM-II for Osteoarthritis Knee Pain

  • The FDA has granted Fast Track designation to MM-II, a non-opioid liposomal suspension, for treating osteoarthritis (OA) knee pain, potentially expediting its development and review.
  • Phase 2b trial data showed a single intra-articular injection of MM-II provided significant pain relief compared to placebo for up to 26 weeks in OA patients.
  • The Fast Track designation highlights the potential of MM-II to address the unmet need for effective and durable treatments for osteoarthritis, a prevalent degenerative joint disease.
  • MM-II demonstrated a greater than 50% improvement in knee pain from weeks 12 to 26, supporting its potential for accelerated regulatory approval.

Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

NCT04506463CompletedPhase 2
Sun Pharmaceutical Industries Limited
Posted 12/22/2020

FDA Issues Draft Guidance on Multiregional Clinical Trials in Oncology

  • The FDA has released draft guidance on multiregional clinical trials (MRCTs) in oncology, aiming to streamline drug development and regulatory review processes.
  • The guidance addresses key considerations for designing and conducting MRCTs, including patient population diversity, regional variations in treatment standards, and data interpretation.
  • This initiative seeks to enhance the efficiency of oncology drug development, potentially accelerating access to novel therapies for patients worldwide.
  • The FDA's guidance emphasizes the importance of robust data collection and analysis to ensure the reliability and generalizability of MRCT results.

FDA Approves Lebrikizumab (Ebglyss) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved lebrikizumab (Ebglyss) for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds.
  • Approval was based on the ADvocate 1, ADvocate 2, and ADhere trials, which showed significant itch relief and skin clearance, sometimes as early as 2-4 weeks.
  • Lebrikizumab, a monoclonal antibody targeting IL-13, offers an alternative for patients who do not respond well to topical corticosteroids.
  • Administered as a monthly injection, lebrikizumab can be used with or without topical corticosteroids, providing a new treatment option for atopic dermatitis patients.

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

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

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

FDA Grants Accelerated Approval to Epcoritamab for Relapsed/Refractory Follicular Lymphoma

  • The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly) for adult patients with relapsed/refractory follicular lymphoma (FL).
  • This approval applies to patients who have previously undergone at least two lines of systemic therapy.
  • The decision was based on data from the phase 1/2 EPCORE NHL-1 trial, which showed an overall response rate of 82%.
  • The trial also demonstrated a complete response rate of 60% in patients treated with epcoritamab.

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

Trending News

1

Nuvalent to Present Pivotal Data for ROS1-Selective Inhibitor Zidesamtinib in Advanced Lung Cancer

3 days ago
2

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

2 days ago
3

EMA Backs Ozempic Label Expansion for Peripheral Artery Disease Based on STRIDE Trial Data

3 days ago
4

TISSIUM Receives FDA De Novo Authorization for First Atraumatic Sutureless Peripheral Nerve Repair System

3 days ago
5

NHS Delivers First Brain-Infused Gene Therapy for Rare AADC Deficiency, Showing Promising Results in Three-Year-Old Patient

2 days ago
6

Lundbeck's Lu AG13909 Receives Orphan Drug Designation for Congenital Adrenal Hyperplasia Treatment

2 days ago
7

OutSee Secures £1.8M Seed Funding to Advance AI-Powered Genomics Platform for Drug Discovery

2 days ago
8

Stuart Therapeutics Reports Mixed Phase III Results for ST-100 Dry Eye Treatment

2 days ago
9

Revolution Medicines Secures $2 Billion Funding Deal with Royalty Pharma for RAS Cancer Drug Development

2 days ago
10

Biogen Advances Salanersen to Phase 3 Studies for Spinal Muscular Atrophy After Promising Results

a day 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