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Lundbeck's Eptinezumab Shows Strong Efficacy in Asian Chronic Migraine Patients in Phase III SUNRISE Trial

Monoclonal Antibody
  • H. Lundbeck A/S announced positive results from the SUNRISE phase III trial, demonstrating eptinezumab's efficacy in a predominantly Asian population with chronic migraine.
  • Patients receiving eptinezumab experienced significant reductions in monthly migraine days, with 300mg and 100mg doses showing -7.5 and -7.2 day reductions respectively versus -4.8 with placebo.
  • The trial met all primary and secondary endpoints, with patients four times more likely to achieve ≥75% reduction in migraine days within the first four weeks compared to placebo.
  • Based on these results, Lundbeck has initiated regulatory discussions to make eptinezumab available across Asia, addressing significant unmet medical needs in the region.

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384CompletedPhase 3
H. Lundbeck A/S
Posted 5/29/2021

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

NCT05064371CompletedPhase 3
H. Lundbeck A/S
Posted 9/21/2021

Efficacy of Erenumab in Chronic Cluster Headache

NCT04970355CompletedPhase 2
Charite University, Berlin, Germany
Posted 12/2/2021

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

NCT04418765CompletedPhase 3
H. Lundbeck A/S
Posted 6/1/2020

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

NCT05452239CompletedPhase 4
H. Lundbeck A/S
Posted 7/1/2022

Bio-Thera Solutions Receives Positive CHMP Opinion for Ustekinumab Biosimilar USYMRO

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.
  • The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis patients.
  • Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval.
  • USYMRO targets IL-12 and IL-23 pathways involved in chronic inflammatory conditions including psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

Atezolizumab Shows Consistent Efficacy in Cervical Cancer Regardless of PD-L1 Status, BEATcc Trial Analysis Reveals

Monoclonal Antibody
  • A post hoc analysis of the phase 3 BEATcc trial demonstrates that atezolizumab combined with chemotherapy and bevacizumab provides consistent clinical benefits in cervical cancer patients irrespective of PD-L1 expression levels.
  • Patients with PD-L1 CPS <1 showed similar progression-free survival improvements (HR 0.48) compared to those with CPS ≥1 (HR 0.54), suggesting PD-L1 may not serve as a predictive biomarker.
  • The findings potentially broaden the eligible patient population for this immunotherapeutic combination, addressing an unmet need for patients with low or unknown PD-L1 status.
  • Interim overall survival data showed median values of 37.3 months versus 19.2 months in the low PD-L1 group, with final results expected in 2026.

Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

NCT03556839Active, Not RecruitingPhase 3
Grupo Español de Investigación en Cáncer de Ovario
Posted 9/25/2018

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

NCT03635567CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 10/25/2018

Dupilumab Treatment for Atopic Dermatitis Linked to Increased Psoriasis Risk in Large-Scale Study

Monoclonal Antibody
  • A large retrospective cohort study of 19,720 patients found that dupilumab treatment for atopic dermatitis was associated with a 58% increased risk of developing psoriasis compared to other systemic therapies.
  • The 3-year cumulative incidence of psoriasis was 2.86% in dupilumab-treated patients versus 1.79% in those receiving alternative systemic treatments, with a number needed to harm of 94.
  • Despite the elevated relative risk, researchers emphasized that the absolute risk increase remains small at 1.07 percentage points over three years, requiring careful consideration against dupilumab's established therapeutic benefits.

CD5-Targeted Therapies Show Promise Across Cancer, Autoimmunity, and Transplantation with First Commercial Launch Expected by 2030

CAR-TMonoclonal Antibody
  • CD5-targeted therapies are advancing through clinical development with fewer than 10 therapies currently in trials and the highest phase reaching Phase II, with first commercial approval expected by 2030.
  • Leading CAR-T candidates MB-105 and VIPER-101 demonstrate acceptable safety profiles and encouraging antitumor activity in relapsed and refractory T-cell malignancies.
  • CD5's therapeutic versatility extends beyond oncology to autoimmune disorders and transplantation medicine, offering potential to modulate immune responses across multiple disease contexts.
  • Despite promising early results, challenges remain including fratricide effects in cancer therapy, immune balance in autoimmunity, and limited long-term safety data for novel approaches.

Tocilizumab Biosimilar CT-P47 Demonstrates Long-Term Efficacy and Safety in Rheumatoid Arthritis Treatment

Monoclonal AntibodyDrug Approval
  • CT-P47, a tocilizumab biosimilar, showed comparable efficacy and safety to reference Actemra over 52 weeks in a phase 3 trial involving 444 rheumatoid arthritis patients.
  • Patients who switched from Actemra to CT-P47 maintained similar disease control with no new safety concerns, supporting biosimilar interchangeability.
  • The biosimilar demonstrated successful self-administration via autoinjector with high patient satisfaction scores and minimal injection site reactions.
  • Multiple tocilizumab biosimilars have gained regulatory approval, offering potential cost savings of 16-26% compared to the originator biologic.

A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis

NCT05725434Not Yet RecruitingPhase 3
Celltrion
Posted 2/6/2023

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

NCT05489224CompletedPhase 3
Celltrion
Posted 9/14/2022

Bionova Scientific Expands into Advanced Therapies with Third FlexFactory Platform Installation

Monoclonal Antibody
  • Bionova Scientific is installing its third FlexFactory manufacturing platform from Cytiva to enter the advanced therapy manufacturing space while maintaining its core monoclonal antibody business.
  • The CDMO will utilize Cytiva's Fast Trak process development services to accelerate entry into genomic medicines manufacturing, specifically plasmid DNA production.
  • The new FlexFactory platform offers reduced business risks, increased operational speed, and enhanced flexibility with built-in compliance features for regulatory adherence.
  • Bionova's new facility in The Woodlands, Texas celebrated its grand opening on May 29, 2025, with the FlexFactory delivery scheduled for Q3 2025.

Memo Therapeutics to Present Phase II Results for First-in-Class BK Polyomavirus Treatment at World Transplant Congress

Monoclonal Antibody
  • Memo Therapeutics will present interim Phase II results for potravitug, a monoclonal antibody targeting BK polyomavirus infection in kidney transplant recipients, at the World Transplant Congress in August 2025.
  • The SAFE KIDNEY II trial enrolled 95 patients across 22 U.S. sites to evaluate potravitug's efficacy against BKPyV infection, which affects up to 50% of kidney transplant recipients.
  • Potravitug represents a potential first-in-class therapy for BKV infection, addressing a significant unmet medical need with no currently approved treatment options available.
  • The drug received FDA fast-track designation in May 2023, recognizing the high medical need in this indication with market potential estimated at up to $2 billion annually.

Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.

NCT05358106CompletedPhase 1
Memo Therapeutics AG
Posted 5/9/2022

Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients

NCT05769582CompletedPhase 2
Memo Therapeutics AG
Posted 4/10/2023

Avalo Therapeutics Appoints Rita Jain to Board as AVTX-009 Phase 2 Trial for Hidradenitis Suppurativa Progresses

Monoclonal Antibody
  • Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors.
  • The appointment comes as the company advances AVTX-009, a high-affinity anti-IL-1β monoclonal antibody, through a Phase 2 LOTUS trial for hidradenitis suppurativa.
  • Dr. Jain previously served as Chief Medical Officer at ChemoCentryx, where she advanced Tavneos (avacopan), a first-in-class treatment for ANCA-associated vasculitis.
  • The Phase 2 LOTUS trial results for hidradenitis suppurativa are expected to read out in the middle of next year.

FDA Approves Tafasitamab Triple Combination for Relapsed/Refractory Follicular Lymphoma

Drug ApprovalMonoclonal Antibody
  • The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma.
  • The phase 3 inMIND trial demonstrated a median progression-free survival of 22.4 months with the tafasitamab combination versus 13.9 months with placebo plus lenalidomide and rituximab.
  • This approval provides the first CD19- and CD20-targeted immunotherapy combination for this patient population, offering a chemotherapy-free treatment option.
  • Serious adverse effects were reported in 33% of patients receiving tafasitamab, with serious infections occurring in 24% of patients.

MInimal Residual Disease Adapted Strategy

NCT04934475Active, Not RecruitingPhase 3
Intergroupe Francophone du Myelome
Posted 12/8/2021

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

NCT02942290Active, Not RecruitingPhase 1
AbbVie
Posted 1/12/2017

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197Active, Not RecruitingPhase 3
Pfizer
Posted 12/18/2017

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT02598661Active, Not RecruitingPhase 2
Geron Corporation
Posted 1/12/2016

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

NCT06434363RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 7/31/2024

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

NCT05718869RecruitingPhase 2
City of Hope Medical Center
Posted 5/18/2023

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