MedPath

Clinical Trial News

Poseida's Allogeneic CAR-T Therapy Shows Promise in Relapsed/Refractory Multiple Myeloma

• P-BCMA-ALLO1, an allogeneic CAR-T therapy from Poseida Therapeutics, demonstrates promising results in heavily pretreated multiple myeloma patients. • The Phase 1/1b trial showed a 91% overall response rate in patients receiving enhanced lymphodepletion, indicating improved efficacy. • No graft-versus-host disease was observed, and cytokine release syndrome was mostly low grade, highlighting a favorable safety profile. • P-BCMA-ALLO1 offers a potential off-the-shelf alternative to autologous CAR-T therapies, addressing the unmet need for immediate treatment options.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

Digital Coaching Service Shows Promise in Managing Hypertension and Depression Comorbidity

  • A randomized control trial in Northumbria assesses the feasibility of using Holly Health's digital coaching service for patients with hypertension and depression/anxiety.
  • After 12 weeks, 64% of patients found the service useful, and 69% reported benefiting from it, with 92% finding it acceptable as a digital health intervention.
  • The study showed improvements in participants' lifestyles, including changes in eating habits and reduced alcohol intake, with many valuing the app's habit-prompting features.
  • The research aims to evaluate the potential of digital health tools to enhance self-management, reduce NHS costs, and improve health outcomes for comorbid conditions.

Claudin 18.2-Targeted Therapies Show Promise in Gastric and Other Cancers

• Claudin 18.2 (CLDN18.2) is a highly selective biomarker abnormally expressed in gastric, gastroesophageal junction, ovarian cancers, and some solid tumors, making it a target for cancer therapies. • Vyloy (zolbetuximab) gained approval in major markets like the US, EU, and Japan, as a first-line treatment with chemotherapy for HER2-negative G/GEJ adenocarcinoma expressing Claudin18.2. • Over 60 Claudin 18.2-targeting drugs are in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates, showing promise in various cancers. • Companion diagnostics, such as Roche's Ventana CLDN18 (43-14A) RxDx Assay, are crucial for identifying patients most likely to benefit from Claudin18.2-targeted therapies, improving treatment outcomes.

Subcutaneous Keytruda Matches IV Efficacy in Phase 3 Lung Cancer Trial

  • Merck's subcutaneous formulation of Keytruda, combined with berahyaluronidase alfa, demonstrated equivalent efficacy to intravenous Keytruda in treating metastatic non-small cell lung cancer.
  • The Phase 3 MK-3475A-D77 trial met its primary endpoint, indicating that subcutaneous Keytruda, administered every six weeks, is as effective as the IV formulation when combined with chemotherapy.
  • Subcutaneous Keytruda offers a more convenient administration method, potentially expanding accessibility and strengthening Merck's market position amid upcoming patent expiry in 2028.
  • The new formulation may also provide pricing advantages for Merck, as it could be treated as a separate drug under Medicare guidelines, allowing continued price setting.

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

NCT05722015Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/14/2023

Amneal Resubmits Migraine Autoinjector NDA and Gains FDA Approval for Generic Exenatide

  • Amneal Pharmaceuticals resubmitted its NDA for a DHE autoinjector, aiming to provide a convenient, at-home treatment for migraine and cluster headaches.
  • The DHE autoinjector eliminates the need for refrigeration and assembly, offering a user-friendly alternative for self-administration during acute attacks.
  • The FDA approved Amneal's exenatide, marking one of the first generic injectable GLP-1 agonists for managing type 2 diabetes.
  • Exenatide approval highlights Amneal's expertise in complex generics and peptide development, positioning them in the growing GLP-1 market.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

• Replimune's RP1 (vusolimogene oderparepvec) has been granted Breakthrough Therapy designation by the FDA for advanced melanoma treatment. • The BLA for RP1 in combination with nivolumab has been submitted to the FDA under the Accelerated Approval pathway. • The designation is based on clinical activity observed in the IGNYTE clinical trial for patients who progressed on anti-PD1 regimens. • A confirmatory Phase 3 trial (IGNYTE-3) is currently enrolling patients with advanced melanoma who have progressed on prior therapies.

UK Pioneers Point-of-Care Manufacturing Framework for Cell Therapies with 2025 Implementation Target

• The UK government has introduced groundbreaking draft legislation to enable point-of-care manufacturing of cell therapies, with implementation expected in summer 2025, potentially becoming the first country with such a framework.
• The proposed system will allow production of therapies at healthcare facilities under MHRA oversight through a central control site, addressing challenges of short shelf-life products and patient-specific cell therapies.
• This innovative approach could revolutionize manufacturing of autologous cell therapies and 3D-printed medicines, while the FDA continues developing its policies for distributed manufacturing models.

FDA Updates Fludarabine Phosphate Labeling for CLL Treatment

  • The FDA has updated the labeling for fludarabine phosphate, expanding its approved use in treating B-cell chronic lymphocytic leukemia (CLL).
  • Fludarabine phosphate is now indicated for CLL patients as part of combination regimens and for those who have progressed on alkylating agents.
  • The updated label includes revised dosage recommendations when fludarabine phosphate is used with cyclophosphamide and rituximab.
  • The label update also highlights potential risks, such as neurological toxicities and myelosuppression, and provides dosage guidelines for combination therapies.

FDA Accepts sNDA for Darolutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer

  • The FDA has accepted a supplemental new drug application (sNDA) for darolutamide in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (HSPC).
  • The sNDA is supported by the phase 3 ARANOTE trial, which demonstrated a significant reduction in the risk of disease progression or death with darolutamide plus ADT compared to placebo plus ADT.
  • Darolutamide plus ADT reduced the risk of radiological progression by 46% compared to placebo plus ADT (HR, 0.54; 95% CI, 0.41-0.71; P < .0001) in the ARANOTE trial.
  • If approved, this expands the indication for darolutamide in metastatic HSPC, offering an additional treatment option with or without chemotherapy.

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

NCT05794906RecruitingPhase 3
Bayer
Posted 4/3/2023

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

NCT04736199Active, Not RecruitingPhase 3
Bayer
Posted 2/23/2021

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

NCT04136353Active, Not RecruitingPhase 3
University of Sydney
Posted 3/31/2020

Abbisko Cayman Initiates Phase II Trial of ABSK061 and ABSK043 for Advanced Solid Tumors

• Abbisko Cayman has commenced a Phase II clinical trial evaluating ABSK061 and ABSK043 in patients with metastatic or unresectable solid tumors harboring FGFR2/3 alterations. • The trial builds on prior studies that demonstrated promising anti-tumor activity and a manageable safety profile for both oral drugs. • This Phase II study represents a significant step forward in the clinical development of ABSK061 and ABSK043 as potential targeted therapies for cancers with specific FGFR alterations.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.