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Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment

Drug ApprovalOncologyCAR-TMonoclonal Antibody
  • Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
  • Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
  • Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.

Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT06006117RecruitingPhase 3
The Lymphoma Academic Research Organisation
Posted 9/5/2023

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235RecruitingPhase 2
Weill Medical College of Cornell University
Posted 11/1/2023

CAR-T Followed by Bispecific Antibodies

NCT04889716RecruitingPhase 2
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658CompletedPhase 2
University of Washington
Posted 3/23/2022

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/27/2021

Upstream Bio Advances Verekitug into Phase 2 Trials for Severe Asthma and Chronic Rhinosinusitis with Nasal Polyps

Monoclonal Antibody
  • Upstream Bio has initiated Phase 2 clinical trials for verekitug (UPB-101), a novel TSLP receptor-blocking monoclonal antibody, in both severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • The VALIANT study in severe asthma will evaluate extended dosing regimens including every 24 weeks, enabled by Phase 1b data showing 54% reduction in disease biomarkers sustained through 32 weeks.
  • Verekitug demonstrated superior potency compared to published tezepelumab data and became the first TSLP signaling inhibitor to maintain maximal biomarker inhibition 24 weeks after the last dose.
  • The drug targets TSLP, a key upstream cytokine in inflammatory cascades, potentially addressing multiple pathological processes with a single treatment approach.

Apogee's APG777 Shows 75-Day Half-Life in Phase 1 Trial for Atopic Dermatitis

Monoclonal Antibody
  • Apogee Therapeutics announced positive Phase 1 interim data for APG777, a novel IL-13-targeting monoclonal antibody with an extended 75-day half-life for atopic dermatitis treatment.
  • The first-in-human trial demonstrated favorable safety profile with single doses up to 1,200mg and multiple doses of 300mg being well-tolerated in 40 healthy volunteers.
  • APG777 showed deep and sustained inhibition of key atopic dermatitis biomarkers for up to 3 months, potentially enabling less frequent dosing intervals.
  • The company plans to initiate a Phase 2 trial in the first half of 2024, enrolling approximately 110 patients in part A and 360 patients in part B for dose optimization.

Isatuximab Combination Therapy Achieves Superior MRD Negativity Rates in Newly Diagnosed Multiple Myeloma

Monoclonal Antibody
  • The isatuximab-carfilzomib-lenalidomide-dexamethasone (Isa-KRd) combination significantly improved minimal residual disease (MRD) negativity rates compared to standard KRd therapy in newly diagnosed multiple myeloma patients.
  • In the phase 3 IsKia trial, Isa-KRd achieved 77% MRD negativity at 10-5 cutoff versus 67% with KRd alone, with even greater differences at the more stringent 10-6 cutoff (67% vs 48%).
  • High-risk multiple myeloma patients showed particularly strong responses, with the GMMG-CONCEPT trial demonstrating 67.7% MRD negativity in transplant-eligible patients and sustained negativity for at least one year in 62.6% of cases.
  • The treatment benefits were observed across all patient subgroups, including those with very high-risk cytogenetic features, while maintaining manageable safety profiles.

Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

NCT03104842Active, Not RecruitingPhase 2
Universitätsklinikum Hamburg-Eppendorf
Posted 8/15/2017

KRDI in Transplant-Eligible MM

NCT04430894Active, Not RecruitingPhase 2
Massachusetts General Hospital
Posted 7/10/2020

Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

NCT04483739Active, Not RecruitingPhase 3
European Myeloma Network B.V.
Posted 9/25/2020

Eptinezumab Demonstrates Sustained Long-Term Efficacy in Treatment-Resistant Migraine Patients Over 18 Months

Monoclonal Antibody
  • The DELIVER trial extension study showed eptinezumab maintained significant migraine reduction benefits for up to 18 months in patients who had failed 2-4 prior preventive treatments.
  • Over 60% of patients achieved at least 50% reduction in monthly migraine days and more than 30% achieved at least 75% reduction by the end of the 18-month follow-up period.
  • Patients reduced acute migraine medication use by approximately 5 days per month, bringing usage below medication overuse thresholds and sustaining this improvement throughout treatment.
  • The study demonstrated excellent tolerability with a 90.4% completion rate and safety profile consistent with previous eptinezumab trials.

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

Eptinezumab in Adults With Migraine and Medication Overuse Headache

NCT04772742CompletedPhase 3
H. Lundbeck A/S
Posted 2/17/2021

Novartis' Ianalumab Achieves Primary Endpoint in Phase III ITP Trial, Offering Potential for Extended Treatment-Free Periods

Monoclonal AntibodyOrphan DrugRare Disease
  • Novartis announced positive Phase III results for ianalumab in immune thrombocytopenia, with the drug significantly prolonging time to treatment failure compared to placebo when combined with eltrombopag.
  • Patients receiving ianalumab experienced significantly higher rates of sustained platelet count improvements at six months, the key secondary endpoint of the VAYHIT2 study.
  • The monoclonal antibody demonstrated a consistent safety profile with no new safety signals, and could potentially offer long-term disease control through just four once-monthly doses.
  • Regulatory submissions are planned for 2027 alongside results from the ongoing first-line ITP trial, with ianalumab having received Orphan Drug Designation from both FDA and EMA.

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NCT05350072Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/28/2022

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

NCT05653349RecruitingPhase 3
Novartis Pharmaceuticals
Posted 3/6/2023

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/14/2022

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NCT05349214Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 8/4/2022

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

NCT06470048RecruitingPhase 2
Novartis Pharmaceuticals
Posted 10/9/2024

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

NCT05648968RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/30/2022

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

NCT05639114RecruitingPhase 3
Novartis Pharmaceuticals
Posted 3/2/2023

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

NCT05653219Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 2/2/2023

Novartis Cosentyx Fails to Meet Primary Endpoint in Phase III Giant Cell Arteritis Trial

Monoclonal Antibody
  • Novartis announced that its Phase III GCAptAIN study of Cosentyx (secukinumab) failed to meet the primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing giant cell arteritis.
  • The global trial evaluated Cosentyx in combination with a 26-week steroid taper compared to placebo plus a 52-week steroid taper across 27 countries.
  • While secondary outcomes showed numerically better results for cumulative steroid dose and steroid-related toxicity, these did not reach statistical significance.
  • The safety profile of Cosentyx in GCA patients remained consistent with its known profile across approved indications, supported by 10 years of real-world data.

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

NCT04930094Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/6/2021

USDA Approves First Therapeutic Treatment for Canine Parvovirus Using Monoclonal Antibody Technology

Monoclonal AntibodyDrug Approval
  • The USDA has granted conditional license for Elanco's Canine Parvovirus Monoclonal Antibody, marking the first approved therapeutic solution to treat canine parvovirus.
  • In efficacy studies, all 28 treated puppies survived with significantly faster recovery times for vomiting, inappetence, and lethargy compared to traditional supportive care.
  • The single intravenous dose treatment could reduce hospitalization costs and make parvovirus treatment more accessible to pet owners who previously couldn't afford intensive care.
  • This breakthrough represents the first monoclonal antibody treatment for Elanco and addresses a critical unmet need in veterinary medicine for a disease with over 90% fatality rate if untreated.

Almirall Launches First Dermatology Study to Assess Patient Wellbeing as Primary Endpoint in Psoriasis Treatment

Monoclonal AntibodyReal World Evidence
  • Almirall has launched the POSITIVE study, the first dermatological research to assess patient wellbeing as a primary endpoint using the WHO-5 questionnaire in 780 adults with moderate-to-severe psoriasis.
  • The 24-month real-world evidence study across nine European countries evaluates tildrakizumab treatment impact on overall wellbeing, family environment, and physician satisfaction.
  • Nearly 77% of psoriasis patients report the disease negatively affects their daily activities and wellbeing, with up to 25% experiencing depression, highlighting the need for holistic treatment approaches.
  • The study represents a paradigm shift from traditional disease burden assessment to positive treatment goals that promote good health and wellbeing in dermatology care.

Trastuzumab Deruxtecan Gains Regulatory Approvals in China and Europe for HER2-Positive Cancers

Drug ApprovalMonoclonal Antibody
  • China's National Medical Products Administration approved trastuzumab deruxtecan for HER2-positive breast cancer patients who received prior anti-HER2 therapies, based on DESTINY-Breast03 trial showing 72% reduction in disease progression risk.
  • The European Commission approved trastuzumab deruxtecan as second-line treatment for HER2-positive advanced gastric cancer, marking the first antibody-drug conjugate approved in Europe for this indication.
  • DESTINY-Breast03 demonstrated superior efficacy with median progression-free survival not reached for trastuzumab deruxtecan versus 6.8 months for trastuzumab emtansine.
  • The approvals expand treatment options for patients with HER2-positive cancers who face poor outcomes after initial therapy progression.

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

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