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Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment

Drug ApprovalOncologyCAR-TMonoclonal Antibody
  • Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
  • Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
  • Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658CompletedPhase 2
University of Washington
Posted 3/23/2022

CAR-T Followed by Bispecific Antibodies

NCT04889716RecruitingPhase 2
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/27/2021

Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT06006117RecruitingPhase 3
The Lymphoma Academic Research Organisation
Posted 9/5/2023

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235RecruitingPhase 2
Weill Medical College of Cornell University
Posted 11/1/2023

Innovent's Mazdutide Achieves Phase 3 Success in Chinese Obesity Trial, Paving Way for First GLP-1R/GCGR Dual Agonist Approval

Drug Approval
  • Innovent Biologics announced that mazdutide, a novel GLP-1R/GCGR dual agonist, successfully met all primary and key secondary endpoints in the GLORY-1 Phase 3 trial for weight management in Chinese adults with overweight or obesity.
  • The 48-week study of 610 participants demonstrated superior weight loss efficacy compared to placebo, with both 4 mg and 6 mg doses showing significant improvements in body weight reduction and cardiometabolic parameters.
  • Mazdutide represents the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials, with Innovent planning to submit a new drug application to China's NMPA in the near term.
  • The trial results address a critical unmet medical need in China, which has the world's highest number of obese individuals, with obesity-related deaths accounting for 11.1% of chronic disease mortality in 2019.

A Study of IBI362 in Participants With Obesity or Overweight

NCT05607680CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 11/14/2022

Travere Therapeutics Advances Filspari Toward FDA Approval Following Pre-NDA Meeting

Drug Approval
  • Travere Therapeutics has completed a pre-NDA meeting with the FDA for Filspari, marking a critical regulatory milestone in the drug's development pathway.
  • The pre-NDA meeting represents a significant step forward in the company's efforts to secure FDA approval for this therapeutic candidate.
  • This regulatory engagement demonstrates Travere's commitment to advancing Filspari through the final stages of the approval process.

CRISPR/Cas9 Technology Revolutionizes CAR-T Cell Therapy: Enhancing Efficacy and Overcoming Treatment Barriers

CAR-TGene EditingDrug Approval
  • CRISPR/Cas9 gene editing technology is being integrated with CAR-T cell therapy to address key limitations including immune checkpoint inhibition, T cell exhaustion, and manufacturing challenges.
  • The technology enables precise knockout of immune checkpoint genes like PD-1 and CTLA-4, significantly enhancing CAR-T cell persistence and anti-tumor activity in preclinical studies.
  • CRISPR/Cas9 facilitates development of universal "off-the-shelf" CAR-T cells by eliminating TCR and HLA genes, potentially reducing manufacturing costs and treatment timelines from weeks to days.
  • Despite promising clinical trial results showing safety and feasibility, researchers continue addressing potential safety concerns including off-target effects and chromosomal instability.

UK Approves World's First CRISPR Gene Therapy for Sickle Cell Disease and β-Thalassemia

Drug ApprovalRare Disease
  • The UK has made a landmark decision to approve the world's first CRISPR-based gene therapy, developed by Vertex Pharmaceuticals, for treating sickle cell disease and β-thalassemia.
  • This one-time treatment offers potential transformation of patient lives by addressing the genetic root cause of these blood disorders, marking a historic milestone in gene editing technology.
  • Despite its therapeutic promise, concerns remain about the high cost of the treatment and questions about accessibility for patients in need, particularly in regions with high disease prevalence.

BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease

NCT05456880RecruitingPhase 1
Beam Therapeutics Inc.
Posted 8/30/2022

Biocon Biologics Secures UK Approval for Aflibercept Biosimilar YESAFILI, Expanding European Market Access

Drug Approval
  • Biocon Biologics received MHRA approval for YESAFILI, a biosimilar of aflibercept, for treating multiple retinal conditions in the UK market.
  • The approval follows European Commission authorization in September 2023, demonstrating comparable quality, safety, and efficacy to reference product Eylea.
  • YESAFILI targets a significant market opportunity with aflibercept generating $790 million in UK sales as of June 2023.
  • The biosimilar expands Biocon's ophthalmology portfolio and strengthens its global presence beyond oncology and diabetes therapeutics.

Cuba Advances Phase III Clinical Trial of Jusvinza for Rheumatoid Arthritis Treatment

Drug Approval
  • Cuban scientists are conducting a Phase III clinical trial of Jusvinza, an immunomodulatory and anti-inflammatory drug, in rheumatoid arthritis patients across the country.
  • The drug received sanitary registration from Cuban regulatory authorities in September after demonstrating quality, safety, and efficacy in treating rheumatoid arthritis.
  • Patients in the trial have shown improved quality of life with no adverse effects reported in the first four doses of treatment.
  • Camagüey province leads enrollment with 212 volunteers, with participants receiving monthly doses for six months after completing the initial four-dose regimen.

FDA Approves Bosutinib for Pediatric Chronic Myelogenous Leukemia Patients

Drug Approval
  • The FDA has approved bosutinib (Bosulif) for pediatric patients aged 1 year or older with Philadelphia chromosome-positive chronic-phase chronic myelogenous leukemia.
  • The approval covers both newly diagnosed patients and those with disease resistant or intolerant to previous therapy.
  • Clinical trial data showed major cytogenetic response rates of 76.2% in newly diagnosed patients and 82.1% in resistant/intolerant patients.
  • The FDA also approved new 50 mg and 100 mg capsule formulations to facilitate pediatric dosing.

Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia

NCT04258943Active, Not RecruitingPhase 1
Children's Oncology Group
Posted 7/6/2020

Bispecific T-Cell Engagers Show Promise as Later-Line Therapies for Relapsed/Refractory DLBCL

CAR-TDrug ApprovalOncology
  • Two bispecific T-cell engagers, epcoritamab-bysp and glofitamab-gxbm, received FDA accelerated approval in 2023 for relapsed/refractory diffuse large B-cell lymphoma, offering new treatment options for heavily pretreated patients.
  • Both agents demonstrate remarkable activity with overall response rates above 50-60% and complete response rates around 40% in patients with CAR T-cell therapy failure, addressing a significant unmet medical need.
  • Epcoritamab offers convenient subcutaneous administration in outpatient settings with manageable cytokine release syndrome rates below 3%, while glofitamab provides fixed-duration therapy with durable responses lasting over one year after treatment completion.
  • These bispecific antibodies may challenge the paradigm that CAR T-cell therapy is the only curative option for relapsed/refractory patients, with emerging data suggesting potential for long-term disease control.

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

NCT03075696RecruitingPhase 1
Hoffmann-La Roche
Posted 2/21/2017

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

European Regulators Recommend Cabometyx for Radioactive Iodine-Refractory Thyroid Cancer Based on 78% Reduction in Disease Progression

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Cabometyx (cabozantinib) for treating radioactive iodine-refractory differentiated thyroid cancer patients who have progressed after prior systemic therapy.
  • The recommendation is based on the COSMIC-311 Phase III trial, which demonstrated a 78% reduction in risk of disease progression or death versus placebo (HR: 0.22; 96% CI: 0.13-0.36; p<0.0001) with a median progression-free survival of 11.0 versus 1.9 months.
  • This positive opinion addresses a critical unmet medical need, as there are currently no standard-of-care treatment options for patients with radioactive iodine-refractory differentiated thyroid cancer who progress after first-line therapy.
  • The CHMP recommendation follows the FDA's approval of Cabometyx in September 2021 for the same indication in adult and pediatric patients 12 years and older.
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