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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.

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

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 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

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

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

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

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

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

Teclistamab-Daratumumab Combination Shows Promising Results in Heavily Pretreated Multiple Myeloma Patients

Monoclonal Antibody
  • The combination of teclistamab and daratumumab demonstrated overall response rates ranging from 70% to 100% across different doses in heavily pretreated multiple myeloma patients with a median of 5 prior lines of therapy.
  • A high proportion of patients achieved deep responses including very good partial responses or better, with responses occurring quickly in the first month and deepening over time.
  • The combination was well-tolerated with no new adverse effects compared to the safety profiles of the individual drugs, supporting its evaluation in the ongoing phase 3 MajesTEC-3 study.
  • Comparative effectiveness data from MajesTEC-1 showed teclistamab significantly improved progression-free survival compared to real-world treatments in triple-class exposed patients.

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT05083169Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/14/2021

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

NCT04108195Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 2/21/2020

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

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 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 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

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

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

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