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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 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 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

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

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 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

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.

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

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

NCT02484547TerminatedPhase 3
Biogen
Posted 9/15/2015

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

NCT02477800TerminatedPhase 3
Biogen
Posted 8/13/2015

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

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

EMA Grants Orphan Drug Designation to ICT01 for Acute Myeloid Leukemia Treatment

Monoclonal Antibody
  • The European Medicines Agency has granted Orphan Drug designation to ICT01, a humanized anti-butyrophilin 3A monoclonal antibody designed to selectively activate γ9δ2 T cells, for treating acute myeloid leukemia.
  • The designation recognizes AML's high unmet medical need and limited treatment options, particularly for older or unfit patients who are not eligible for intensive chemotherapy.
  • ICT01 represents a novel immunotherapeutic approach targeting butyrophilin 3A to activate specific T cell populations for cancer treatment.

Prestige Biopharma Partners with Teva Israel for Trastuzumab Biosimilar Commercialization

Monoclonal AntibodyOncology
  • Prestige Biopharma has entered an exclusive commercialization agreement with Teva Israel for its trastuzumab biosimilar Tuznue (HD201) targeting HER2-positive breast cancer and gastric adenocarcinoma.
  • Phase 3 TROIKA trial data demonstrated equivalent efficacy to Herceptin with 46.6% complete response rate in the biosimilar arm versus 46.2% for the reference product.
  • The European Medicines Agency is currently reviewing the marketing authorization application for Tuznue based on positive clinical trial results.
  • This partnership expands Prestige's global commercialization strategy, following previous agreements with Pharmapark for Russia and Mundipharma for multiple European markets.

FDA Approves Monjuvi in Combination with Lenalidomide for Relapsed/Refractory DLBCL

Drug ApprovalMonoclonal AntibodyOncology
  • The FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide as the first second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
  • The approval was based on the Phase 2 L-MIND study, which demonstrated a 55% overall response rate with a 37% complete response rate and median duration of response of 21.7 months.
  • Approximately 10,000 patients are diagnosed annually in the United States with relapsed or refractory DLBCL who are not eligible for stem cell transplant, representing a significant unmet medical need.
  • Monjuvi is a humanized CD19-targeting monoclonal antibody that received accelerated approval and will be co-commercialized by MorphoSys and Incyte in the United States.

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

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