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Benralizumab Shows Superior Long-Term Outcomes in Eosinophilic Granulomatosis with Polyangiitis

  • The MANDARA study extension demonstrates that benralizumab maintains remission in 62.1% of EGPA patients through 104 weeks, with 43.9% achieving complete oral glucocorticosteroid withdrawal.
  • Benralizumab's superior eosinophil depletion mechanism, targeting IL-5 receptors rather than IL-5 directly, provides more complete and rapid eosinophil suppression compared to mepolizumab.
  • Real-world evidence confirms that IL-5 pathway inhibitors significantly reduce disease burden, with mepolizumab showing 18% reduction in daily oral corticosteroid use and 49% decrease in EGPA-related hospitalizations.
  • The convenience advantage of benralizumab's monthly dosing versus mepolizumab's requirement for three monthly injections may improve patient compliance and treatment outcomes.

Roche's PiaSky Becomes First Subcutaneous PNH Therapy Approved in EU

  • Roche's PiaSky (crovalimab) has received European Commission approval as the first subcutaneous therapy for paroxysmal nocturnal haemoglobinuria (PNH) that can be self-administered monthly at home.
  • The approval is based on COMMODORE 2 trial data showing PiaSky was equivalent to AstraZeneca's Soliris in controlling red blood cell destruction while reducing blood transfusion needs.
  • PiaSky now has regulatory clearance in the top four global pharmaceutical markets including China, Japan, the US, and EU, positioning it to compete with established intravenous therapies.
  • The drug faces emerging competition from oral therapies including Novartis' recently approved Fabhalta, which analysts predict could reach $3.6 billion in peak annual sales.

Japanese Intergroup Phase III Trial Evaluates Ramucirumab Plus Irinotecan for Third-Line Advanced Gastric Cancer Treatment

  • A large-scale Japanese intergroup phase III trial is investigating ramucirumab plus irinotecan versus irinotecan alone for patients with advanced gastric cancer who have progressed on prior ramucirumab-containing therapy.
  • The study recruits patients from 110 institutions across 9 clinical trial groups in Japan, with a primary endpoint of overall survival and an assumed hazard ratio of 0.77.
  • As of January 2018, 87 of the planned 400 patients had been enrolled, representing the first major trial to evaluate sustained VEGF blockade in the third-line setting for gastric cancer.
  • Preliminary data from a separate phase II study demonstrated the feasibility of irinotecan-based combinations in second-line gastric cancer, with manageable toxicity profiles and encouraging survival outcomes.

Amgen Challenges Bristol-Myers Squibb Patents for Opdivo-Yervoy Combination Therapy in Patent Review Proceedings

  • Amgen filed three inter partes review petitions on February 28, 2025, challenging Bristol-Myers Squibb patents covering combination treatment methods using Opdivo (nivolumab) and Yervoy (ipilimumab).
  • The challenged patents cover methods for treating various cancers including melanoma and microsatellite instability-high colorectal cancer using the anti-PD-1 and anti-CTLA-4 antibody combination.
  • Amgen is currently conducting Phase III trials for ABP 206, an investigational biosimilar of Opdivo, marking the first patent challenge to Opdivo by a potential biosimilar competitor.
  • Bristol-Myers Squibb reported $5.35 billion in U.S. sales for Opdivo in 2024, highlighting the significant commercial stakes involved in this patent dispute.

Fatal Immune Checkpoint Inhibitor Overlap Syndrome: New Case Series Reveals Critical Management Insights

  • A Spanish case series documents four patients who developed the rare but deadly myocarditis-myositis-myasthenia gravis (MMM) overlap syndrome following immune checkpoint inhibitor therapy, with mortality rates reaching 40-60%.
  • The syndrome typically manifests within 21 days of treatment initiation, presenting with cardiac arrhythmias, muscle weakness, and respiratory complications requiring immediate aggressive immunosuppression.
  • Early combination therapy with corticosteroids and intravenous immunoglobulin showed improved outcomes, with one case achieving complete recovery using rituximab and tocilizumab for refractory symptoms.
  • The research identifies anti-titin antibodies and complement activation as potential biomarkers, while highlighting the need for routine creatine kinase monitoring during initial treatment cycles.
NCT04576429RecruitingNot Applicable
Assistance Publique - Hôpitaux de Paris
Posted 1/27/2021
NCT03293784CompletedPhase 1
Institut Claudius Regaud
Posted 10/16/2017
NCT05034536RecruitingPhase 2
Massachusetts General Hospital
Posted 2/7/2022
NCT04163289Active, Not RecruitingPhase 1
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Posted 1/23/2020
NCT04797325RecruitingPhase 2
University of Copenhagen
Posted 8/30/2021

New Study Highlights Benefits of Maintaining High Factor VIII Levels in Hemophilia A Patients

• Maintaining high Factor VIII (FVIII) levels in people with hemophilia A provides significant clinical benefits, including reduced bleeding risk and better joint health preservation.
• Despite advances in prophylactic treatment, standard-of-care prophylaxis does not completely prevent joint damage or chronic pain, with approximately 47% of hemophilia patients experiencing ongoing pain.
• Recent innovations in hemophilia treatment, including extended half-life therapies, non-factor replacement options, and gene therapy, offer new approaches to sustaining higher FVIII levels and improving patient outcomes.

Cancer Monoclonal Antibody Partnerships Surge with 599 Deals Recorded Since 2016

  • A comprehensive analysis reveals 599 cancer monoclonal antibody collaboration and licensing deals have been announced since 2016, demonstrating sustained industry investment in this therapeutic area.
  • The deals encompass multicomponent partnerships that typically begin with collaborative research and development and progress to commercialization of therapeutic outcomes.
  • Leading biopharma companies are actively pursuing cancer monoclonal antibody partnerships, with detailed financial terms including upfront payments, milestone payments, and royalty structures being tracked across transactions.
  • The report identifies the top 25 most active companies in cancer monoclonal antibody dealmaking, providing insights into partnership strategies and market dynamics in oncology therapeutics.

Bevacizumab Benefits in Colorectal Cancer Limited to Two-Year Window, New Analysis Reveals

  • A comprehensive review presented at the 2025 ASCO Gastrointestinal Cancers Symposium reveals bevacizumab (Avastin) provides survival benefits in colorectal cancer patients for approximately two years after initial administration.
  • Researchers found that after 20-24 months, the initial survival benefit from bevacizumab diminishes, potentially explaining the crossover of survival curves observed in the PARADIGM trial compared to panitumumab (Vectibix).
  • The study suggests bevacizumab treatment may lead to selection of more aggressive tumor clones over time, characterized by accelerated growth and invasiveness after the initial period of tumor stasis and shrinkage.

Immunotherapy Advances Show Promise for Pediatric Osteosarcoma Treatment

  • Pediatric osteosarcoma remains a challenging malignancy with poor prognosis despite treatment advances, with pulmonary metastasis occurring in over 85% of metastatic cases.
  • The tumor microenvironment plays a crucial role in disease progression, with tumor-associated macrophages and T cells being predominant immune infiltrates that influence patient outcomes.
  • Emerging immunotherapies including mifamurtide, CAR-T cell therapy, and immune checkpoint inhibitors demonstrate therapeutic potential, though overcoming immunosuppressive factors remains essential.
  • Novel prognostic biomarkers within the immune microenvironment, including immune-related gene signatures and inflammatory markers, could guide individualized treatment strategies.

Visugromab Plus Nivolumab Shows Promise in Anti-PD-1 Refractory Solid Tumors by Targeting GDF-15 Pathway

  • Visugromab (CTL-002), a GDF-15 neutralizing antibody, combined with nivolumab demonstrated initial efficacy in the phase 2A GDFATHER-TRIAL for patients with advanced solid tumors that had relapsed or were refractory to prior anti-PD-1/PD-L1 therapy.
  • GDF-15 plays a critical role in tumoral immunosuppression by blocking immune cell entry into the tumor microenvironment and interfering with immune synapse formation, which many tumors exploit to resist immunotherapy.
  • The combination therapy represents a novel approach to overcome immunotherapy resistance by neutralizing GDF-15's immunosuppressive effects and potentially restoring T-cell function in the tumor microenvironment.
  • This therapeutic strategy addresses a significant unmet medical need for patients whose cancers have progressed on checkpoint inhibitor therapy, offering a potential pathway to re-sensitize tumors to immune-based treatments.
NCT05351788RecruitingPhase 2
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 5/20/2022
NCT05276609RecruitingPhase 1
Shanghai Hansoh Biomedical Co., Ltd
Posted 11/28/2021
NCT05874648Not Yet Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Posted 7/7/2023
NCT01792934Active, Not RecruitingNot Applicable
Radboud University Medical Center
Posted 5/1/2013
NCT05745623RecruitingPhase 1
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 12/27/2022
NCT05631262Active, Not RecruitingPhase 2
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 11/30/2022
NCT04685226RecruitingPhase 1
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 9/27/2020
NCT04728633Active, Not RecruitingPhase 2
Thomas Jefferson University
Posted 9/27/2021
NCT04802590RecruitingPhase 2
The Lymphoma Academic Research Organisation
Posted 1/24/2022
NCT06536400RecruitingPhase 1
Haisco Pharmaceutical Group Co., Ltd.
Posted 6/25/2024
NCT05265091Active, Not RecruitingPhase 1
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/1/2021
NCT05384587Active, Not RecruitingPhase 2
Novartis Pharmaceuticals
Posted 11/11/2022
NCT06081920RecruitingPhase 2
Innovent Biologics (Suzhou) Co. Ltd.
Posted 10/19/2023
NCT06224387RecruitingPhase 1
CytosinLab Therapeutics Co., Ltd.
Posted 6/26/2023
NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020
NCT02631447CompletedPhase 2
Fondazione Melanoma Onlus
Posted 11/14/2016
NCT05953662Active, Not RecruitingNot Applicable
Sixth Affiliated Hospital, Sun Yat-sen University
Posted 9/1/2023
NCT06361927RecruitingPhase 2
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Posted 5/15/2024
NCT05445908RecruitingPhase 2
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Posted 8/17/2022
NCT05347134Active, Not RecruitingPhase 3
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/10/2022
NCT04959500Unknown StatusPhase 2
Sun Yat-sen University
Posted 6/10/2021

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