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Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial

OncologyMonoclonal Antibody
  • The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
  • This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
  • Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.

A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

NCT04712643Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/12/2021

Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216CompletedPhase 3
Air Force Military Medical University, China
Posted 9/1/2013

Upstream Bio Appoints Stacy Price as Chief Technology Officer to Advance Verekitug Development

Monoclonal Antibody
  • Upstream Bio has appointed Stacy Price as Chief Technology Officer, bringing over 25 years of biotechnology experience to oversee technical operations and product development for verekitug.
  • Price will focus on chemistry, manufacturing, and controls (CMC) processes and drug delivery as Upstream Bio prepares to initiate a third clinical program for verekitug, their monoclonal antibody targeting inflammatory respiratory diseases.
  • The appointment comes at a pivotal time for Upstream Bio as they advance verekitug in Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with plans to expand into chronic obstructive pulmonary disease.

Faron Pharmaceuticals Appoints Ralph Hughes as Chief Business Officer to Advance Immunotherapy Pipeline

OncologyMonoclonal Antibody
  • Faron Pharmaceuticals has appointed Ralph Hughes as Chief Business Officer, bringing extensive experience in commercial strategy and market access from his previous roles at PharmaVentures, Mundipharma, and Pfizer.
  • Hughes joins Faron at a critical time as the company advances its lead immunotherapy candidate bexmarilimab, currently in Phase I/II trials for acute myeloid leukemia and myelodysplastic syndrome.
  • Bexmarilimab targets the Clever-1 receptor on macrophages, potentially overcoming cancer treatment resistance by reprogramming the tumor microenvironment and enhancing immune system response against cancer cells.

Triveni Bio Initiates First-in-Human Trial of TRIV-509 for Atopic Dermatitis, Targeting Novel Kallikrein Pathway

Monoclonal Antibody
  • Triveni Bio has begun dosing healthy volunteers in a Phase 1 clinical trial for TRIV-509, a dual inhibitor of kallikreins 5 and 7 (KLK5/7) designed to treat moderate-to-severe atopic dermatitis.
  • Preclinical data presented at SID 2025 demonstrated TRIV-509's ability to rapidly improve skin barrier integrity, reduce epidermal thickness, and increase desmoglein-1 expression in atopic dermatitis patient explants.
  • The company is also advancing TRIV-573, a next-generation bispecific antibody targeting both KLK5/7 and IL-13, currently in IND-enabling studies, expanding their novel approach to inflammatory skin disorders.

Zura Bio Launches Phase II TibuSHIELD Trial for Novel Dual-Inhibitor in Hidradenitis Suppurativa

Monoclonal Antibody
  • Zura Bio has initiated the Phase II TibuSHIELD trial evaluating tibulizumab, a first-of-its-kind dual inhibitor targeting both BAFF and IL-17A pathways in patients with moderate to severe hidradenitis suppurativa.
  • The global, randomized, double-blind, placebo-controlled study will enroll approximately 180 patients across the US, Canada, and Europe, with topline efficacy results expected in Q3 2026.
  • This trial represents Zura Bio's second Phase II study for tibulizumab, following the December launch of TibuSURE for systemic sclerosis, advancing their portfolio of treatments for severe inflammatory diseases.

Belimumab Shows Superior Efficacy for Systemic Lupus Erythematosus in Meta-Analysis

Monoclonal Antibody
  • A comprehensive meta-analysis of five randomized controlled trials confirms belimumab's superior efficacy over placebo in treating systemic lupus erythematosus (SLE) according to BICLA criteria.
  • Patients receiving belimumab demonstrated significantly higher response rates regardless of baseline glucocorticoid dose, with particularly strong results in those with high disease activity or serologically active disease.
  • The findings validate belimumab's clinical efficacy through an additional widely used responder index, supporting its use in SLE management according to current recommendations.

Dupixent Demonstrates Superior Efficacy Over Xolair in First Head-to-Head Respiratory Study

Monoclonal Antibody
  • Dupixent outperformed Xolair across all primary and secondary efficacy endpoints in the EVEREST phase 4 study of 360 adults with severe chronic rhinosinusitis with nasal polyps and coexisting asthma.
  • The study showed Dupixent achieved superior improvements in nasal polyp size reduction (1.60-point difference), smell identification (8.0-point difference), and lung function (150 mL difference) compared to Xolair at 24 weeks.
  • This represents the first-ever head-to-head comparison between biologic medicines in respiratory diseases, with Dupixent demonstrating rapid improvements as early as 4 weeks across both upper and lower respiratory endpoints.
  • Safety profiles were generally similar between treatments, with adverse events reported in 64% of Dupixent patients versus 67% of Xolair patients.

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

NCT04998604CompletedPhase 4
Sanofi
Posted 9/27/2021

FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma

Monoclonal AntibodyOncology
  • The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
  • The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
  • Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.

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

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/7/2017

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

Tourmaline Bio's Heart Disease Antibody Shows Promise in Phase 2, But Shares Fall Amid Competition Concerns

Monoclonal Antibody
  • Tourmaline Bio's antibody drug pacibekitug demonstrated significant reduction in cardiovascular risk biomarkers compared to placebo in Phase 2 trials, but shares fell 18% as investors question its competitive edge against Novo Nordisk's offering.
  • Schrödinger announced CFO Geoffrey Porges will leave the company amid near-record low share prices, coinciding with plans to lay off 7% of staff as part of cost-cutting measures.
  • CRISPR Therapeutics is expanding its technological capabilities through a $95 million deal with Sirius Therapeutics to develop SRSD107, a novel siRNA blood thinner designed to minimize bleeding risk.

Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025

OncologyMonoclonal Antibody
  • Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma treatment.
  • The company will present research on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma, addressing significant unmet medical needs.
  • Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma will be featured in an oral presentation.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

NCT03713593CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2018

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

NCT04008797RecruitingPhase 1
Eisai Inc.
Posted 7/11/2019

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

NCT04662710Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/30/2020

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