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Clinical Trial News

FDA Approves Dupixent as First Treatment for CRSwNP in Adolescents

• The FDA has approved Dupixent (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). • This marks the first approved treatment option for CRSwNP in this younger age group, addressing a significant unmet need in upper airway inflammatory diseases. • The approval was based on data from adult trials (SINUS-24 and SINUS-52) and pharmacokinetic data from adolescent asthma studies, demonstrating efficacy and safety. • Dupixent, a monoclonal antibody targeting interleukin-4 and interleukin-13, has now been approved in over 60 countries for various type 2 inflammation-related diseases.

MEDSIR Presents Promising Results in Breast and Thymic Cancer Trials at ESMO

• The ABIGAIL study showed that abemaciclib with endocrine therapy achieved a 59% overall response rate at 12 weeks in HR+/HER2- advanced breast cancer, versus 40% with chemotherapy. • The PECATI study demonstrated an 88% progression-free rate at 5 months using lenvatinib and pembrolizumab in advanced thymic tumors, offering a potential new standard of care. • MEDSIR also hosted MEDTalks, focusing on advancing research in brain metastasis, a critical unmet need in solid tumors like lung, breast, and skin cancers.

Deep Learning Identifies Behavioral Risk Profiles for Ventricular Arrhythmias

  • A new study uses deep learning to analyze physical behavior data from wearable accelerometers to predict the risk of malignant ventricular arrhythmias.
  • The study identified distinct behavioral profiles associated with varying risks of ICD therapy and death in patients with ICDs.
  • Findings suggest that behavioral patterns, captured through wearable technology and analyzed with AI, can improve risk stratification for ventricular arrhythmias.
  • This approach offers a novel way to personalize management strategies for patients at risk of life-threatening arrhythmias.

Elicio Therapeutics to Present mKRAS Vaccine Data at Multiple Conferences

  • Elicio Therapeutics will present Phase I AMPLIFY-7P trial updates at the AACR Special Conference on Pancreatic Cancer, highlighting clinical actionability.
  • The company will also present at the RAS-Targeted Drug Development Summit, focusing on the clinical translation of its RAS-targeted Amphiphile vaccines.
  • Elicio will share Phase I experience with ELI-002 2P and ELI-002 7P at the Advances in Cancer Vaccines Summit, detailing lymph node-targeted mKRAS-specific amphiphile vaccine in gastrointestinal tumors.

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

  • Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a statistically significant increase in body weight compared to placebo in cancer cachexia patients.
  • The highest dose of ponsegromab (400 mg) led to a 5.61% mean increase in body weight at 12 weeks, along with improvements in appetite, cachexia symptoms, physical activity, and muscle mass.
  • The study included patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer, showing the drug was generally safe and well-tolerated across all dose levels.
  • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive Phase 2 results, with ponsegromab also under investigation for heart failure.

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

IO Biotech's IO102-IO103 Plus Pembrolizumab Shows Promise in Head and Neck Cancer

• IO Biotech's Phase 2 trial of IO102-IO103 with pembrolizumab demonstrates a 44.4% overall response rate in PD-L1 high recurrent or metastatic SCCHN patients. • The combination therapy shows an encouraging median progression-free survival of 6.6 months and a disease control rate of 66.7% in SCCHN. • The safety profile of IO102-IO103 with pembrolizumab is consistent with previous studies, showing no new systemic toxicity concerns. • These results support further investigation of IO102-IO103 plus pembrolizumab as a first-line treatment for advanced head and neck cancer.

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

NCT05077709Active, Not RecruitingPhase 2
IO Biotech
Posted 2/14/2022

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

NCT05280314RecruitingPhase 2
IO Biotech
Posted 12/21/2023

FDA Approves Ocrevus ZUNOVO: First Subcutaneous Injection for Multiple Sclerosis

  • The FDA has approved Ocrevus ZUNOVO as the first and only twice-yearly, 10-minute subcutaneous injection for relapsing and primary progressive multiple sclerosis.
  • Ocrevus ZUNOVO offers an alternative administration method, potentially expanding treatment access to centers with IV constraints or limited infrastructure.
  • Backed by a decade of safety and efficacy data from Ocrevus IV, the new formulation demonstrated consistent suppression of relapse activity and MRI lesions in trials.
  • The approval provides multiple sclerosis patients with more flexible treatment options tailored to individual needs, enhancing convenience and accessibility.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825CompletedPhase 3
Hoffmann-La Roche
Posted 5/3/2022

Daiichi Sankyo's DS-9606 Shows Promise in Phase I Trial for Advanced Solid Tumors

  • Daiichi Sankyo's DS-9606, an antibody-drug conjugate (ADC) targeting Claudin-6 (CLDN6), demonstrates promising clinical activity in patients with advanced solid tumors.
  • The Phase I trial assessed DS-9606's safety, tolerability, and efficacy, with preliminary results showing confirmed objective responses in heavily pretreated patients.
  • No dose-limiting toxicities were observed, and the most common treatment-emergent adverse events were nausea, fatigue, and anemia, with manageable Grade 3 or higher events.
  • Further evaluation in dose expansion cohorts is planned to determine the maximum tolerated dose and recommended dose for expansion across various CLDN6-expressing tumor types.

Signatera MRD Test Demonstrates Clinical Utility in Colorectal and Breast Cancer Studies

• Natera's Signatera MRD test shows promise in predicting overall survival in colorectal cancer (CRC) patients, potentially changing post-surgical management. • In CRC, Signatera-positive patients after liver metastasis resection benefited from adjuvant chemotherapy, while Signatera-negative patients did not show significant benefit. • The BELLINI trial indicates that ctDNA analysis with Signatera can identify clinical responders to immune checkpoint inhibitors in triple-negative breast cancer (TNBC). • These findings, from over 85 peer-reviewed publications, highlight Signatera's role in optimizing treatment decisions across multiple cancer types.

FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for Atopic Dermatitis Treatment

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis (eczema) in patients 12 years and older.
  • Ebglyss, a targeted IL-13 inhibitor, is administered as a monthly injection after an initial treatment phase to reduce eczema inflammation.
  • Clinical trials demonstrated that Ebglyss led to clear or almost clear skin in 38% of patients at 16 weeks, with sustained results in a majority at one year.
  • Lilly plans to launch Ebglyss in the U.S. soon, offering patient support programs to ensure access, and the drug has already been approved in the EU and Japan.

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