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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.

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

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 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

Polatuzumab Vedotin Shows Superior Efficacy in First-Line DLBCL Treatment and Confirms Long-Term Benefits in Relapsed Disease

Monoclonal AntibodyDrug Approval
  • The phase 3 POLARIX trial demonstrated that polatuzumab vedotin plus R-CHP (pola-R-CHP) significantly improved progression-free survival compared to standard R-CHOP in previously untreated DLBCL patients, reducing the risk of disease progression by 27%.
  • Long-term follow-up data from the GO29365 study confirmed durable disease control with polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL, with 25% of patients achieving ongoing responses lasting over 2 years.
  • Both studies showed manageable safety profiles for polatuzumab vedotin combinations, with peripheral neuropathy rates comparable to standard regimens and no new safety signals identified with extended follow-up.

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

NCT02257567CompletedPhase 1
Hoffmann-La Roche
Posted 10/15/2014

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/16/2017

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

NCT04332822RecruitingPhase 3
Nordic Lymphoma Group
Posted 8/19/2020

Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04665765Active, Not RecruitingPhase 2
City of Hope Medical Center
Posted 1/18/2021

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT04182204CompletedPhase 3
Hoffmann-La Roche
Posted 2/7/2020

UK Approves First COVID-19 Monoclonal Antibody Treatment as AstraZeneca Reports 77% Efficacy in Prevention Trial

Monoclonal AntibodyDrug Approval
  • The UK's MHRA approved Ronapreve, the first monoclonal antibody therapy specifically designed to treat and prevent COVID-19, developed by Regeneron and Roche.
  • The treatment combines two monoclonal antibodies administered by injection or infusion, working by binding to the virus and preventing respiratory system entry.
  • AstraZeneca simultaneously announced that its AZD7442 antibody combination reduced COVID-19 symptom risk by 77% in a trial of 5,172 participants, with over three-quarters having comorbidities affecting vaccine response.
  • Both treatments represent significant advances for vulnerable populations who may not respond adequately to COVID-19 vaccines alone.

FDA Approves Aduhelm: First Disease-Modifying Alzheimer's Treatment in Nearly Two Decades

Drug ApprovalMonoclonal AntibodyNeurology
  • The FDA granted accelerated approval to Biogen's aducanumab (Aduhelm) as the first disease-modifying Alzheimer's treatment in nearly two decades, despite divided expert opinions on its clinical efficacy.
  • Aduhelm, priced at $56,000 annually, works by reducing amyloid plaques in the brain and will require monthly intravenous infusions with comprehensive clinical and MRI monitoring for potential adverse effects.
  • As part of the accelerated approval, Biogen must conduct a Phase 4 confirmatory trial, while experts view this approval as a potential catalyst for developing more effective Alzheimer's treatments targeting multiple pathways.

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

NCT02484547TerminatedPhase 3
Biogen
Posted 9/15/2015

Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

NCT01677572TerminatedPhase 1
Biogen
Posted 10/5/2012

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

NCT04241068TerminatedPhase 3
Biogen
Posted 3/2/2020

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

NCT02477800TerminatedPhase 3
Biogen
Posted 8/13/2015

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

NCT03639987TerminatedPhase 2
Biogen
Posted 12/20/2018

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