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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.

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

KRDI in Transplant-Eligible MM

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

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

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

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.

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

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

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

NCT06470048RecruitingPhase 2
Novartis Pharmaceuticals
Posted 10/9/2024

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

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

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

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

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

NCT05653349Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 3/6/2023

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

FDA Rejects Outlook Therapeutics' Wet AMD Drug Due to Manufacturing Issues and Insufficient Clinical Evidence

Monoclonal Antibody
  • The FDA issued a complete response letter rejecting Outlook Therapeutics' bevacizumab-vikg (ONS-5010) for wet age-related macular degeneration treatment, citing manufacturing deficiencies and need for additional clinical data.
  • Despite meeting primary safety and efficacy endpoints in the Phase III NORSE TWO trial, the agency determined there was a lack of substantial evidence in the biologics license application.
  • Outlook Therapeutics' stock plummeted 80% following the rejection, with the company losing an estimated $989 million in potential 2029 revenue according to GlobalData consensus forecasts.
  • The company plans to request a Type A meeting with the FDA to understand application deficiencies and determine next steps for potential resubmission.

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.

Radiopharm Theranostics Expands Partnership with GenesisCare for Phase I Radiopharmaceutical Trials in Australia

Monoclonal AntibodyOncology
  • Radiopharm Theranostics has expanded its strategic research collaboration with GenesisCare to conduct Phase I trials of three radiopharmaceutical candidates targeting hard-to-treat cancers in Australia.
  • The trials will evaluate a PDL-1 targeting nano-mAb for non-small cell lung cancer, a PTPu targeting peptide for brain tumors, and a PSA targeting antibody for prostate cancer.
  • Radiopharmaceuticals deliver small doses of radiation to specifically targeted cells for therapeutic or diagnostic purposes, offering new hope to patients who have exhausted other treatment options.
  • The two-year collaboration leverages GenesisCare's contract research organization capabilities across its 440+ locations in Australia, UK, US, and Spain.

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

FDA Approves First CGRP-Targeting Therapy for Pediatric Migraine Prevention

Drug ApprovalMonoclonal Antibody
  • The FDA approved fremanezumab (Ajovy) for preventive treatment of episodic migraine in children and adolescents aged 6-17 years, marking the first anti-CGRP monoclonal antibody approved for pediatric use.
  • The Phase III SPACE trial demonstrated statistically significant reductions in monthly migraine days (-2.5 vs -1.4 with placebo) and a 47.2% responder rate compared to 27.0% with placebo.
  • This approval addresses a significant unmet need in pediatric migraine care, where approximately 7.7% of children and adolescents are affected but have had limited FDA-approved preventive treatment options.

Fremanezumab Compassionate Use Program for Pediatric Patients

NCT03539393available
Teva Branded Pharmaceutical Products R&D, Inc.

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

NCT04458857CompletedPhase 3
Teva Branded Pharmaceutical Products R&D, Inc.
Posted 7/15/2020

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