MedPath

Tagged News

Lunit Presents 12 AI-Powered Studies at ASCO 2025, Demonstrating Enhanced Cancer Treatment Selection

AIOncology
  • Lunit will present 12 studies at ASCO 2025 showcasing AI-powered digital pathology solutions for precision oncology applications.
  • A key study with Japan's National Cancer Center demonstrated AI-enhanced HER2 analysis in biliary tract cancer, identifying additional responders to trastuzumab deruxtecan with 50% objective response rate.
  • AI-powered PD-L1 evaluation showed 70% concordance with expert pathologists and identified 231 additional immunotherapy candidates among 949 lung cancer patients.
  • Research includes novel AI models for predicting CLDN18.2 expression in gastric cancer and comprehensive tumor microenvironment analysis across multiple cancer types.

Huonslab Completes Patient Enrollment in Phase 1 Pivotal Study for Recombinant Human Natural Killer Cell Therapy

Oncology
  • Huonslab has achieved last-patient-in milestone for its Phase 1 pivotal study evaluating recombinant human natural killer cell therapy, marking a significant advancement in cellular immunotherapy development.
  • The completion of patient enrollment represents a critical step toward potential regulatory approval for this novel NK cell-based treatment approach.
  • This milestone positions Huonslab to advance its innovative cellular therapy platform and potentially address unmet medical needs in oncology and immunotherapy.

Iran Becomes First Asian Country to Develop Electrochemotherapy Cancer Treatment Technology

OncologyTargeted Therapy
  • Iran has successfully launched the first domestically-developed production line for electrochemotherapy (ECT) ablative devices, joining only Italy and the United Kingdom in producing this advanced cancer treatment technology.
  • The electrochemotherapy system uses electric pulses to increase cancer cell membrane permeability, significantly enhancing the effectiveness of anti-cancer drugs for targeted tumor treatment.
  • Over 1,000 patients have been treated with ECT technology, with more than 200 cases achieving successful outcomes that prevented the need for amputation procedures.
  • This achievement represents a major milestone for Iran's biotechnology sector and positions the country as a leader in advanced cancer treatment technologies within Asia.

SeqOne Genomics Secures €20 Million to Accelerate AI-Powered NGS Platform for Personalized Medicine

AIOncology
  • SeqOne Genomics raised €20 million in an oversubscribed growth round led by Supernova Invest to advance its AI-driven genomic analysis platform for clinical diagnostics.
  • The French company has achieved remarkable growth with 140 laboratory customers across 22 countries and expects to process over 110,000 patient analyses in 2025.
  • Funding will support global expansion, U.S. market acceleration following Q1 2025 launch, and strategic acquisitions to enhance multi-omics capabilities.
  • SeqOne's platform provides clinical decision-support tools for oncology and rare disease applications, positioning the company as a European leader in NGS data interpretation.

Abbisko's FGFR4 Inhibitor Irpagratinib Receives China's Breakthrough Therapy Designation for Hepatocellular Carcinoma

Precision MedicineOncologyMonoclonal AntibodyTargeted Therapy
  • Abbisko Therapeutics' irpagratinib (ABSK011) has received Breakthrough Therapy Designation from China's NMPA for treating hepatocellular carcinoma, marking the first precision-targeted therapy using molecularly defined biomarkers for this indication.
  • The highly selective FGFR4 inhibitor targets FGF19 overexpression, which affects approximately 30% of HCC patients worldwide and is associated with significantly worse prognosis.
  • Clinical data from the 2024 ESMO GI Congress showed irpagratinib combined with atezolizumab achieved a 50% objective response rate in FGF19-positive HCC patients previously treated with immune checkpoint inhibitors.
  • The designation will expedite regulatory approval processes, potentially making irpagratinib the first globally approved FGFR4 inhibitor for HCC treatment.

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

NCT05904886Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 9/14/2023

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

NCT04524871RecruitingPhase 1
Hoffmann-La Roche
Posted 11/1/2020

A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients

NCT05441475RecruitingPhase 2
Abbisko Therapeutics Co, Ltd
Posted 12/30/2021

Immutep's Eftilagimod Alpha Combination Meets Primary Endpoint in Phase II Soft Tissue Sarcoma Trial

Oncology
  • Immutep's EFTISARC-NEO Phase II trial demonstrated that eftilagimod alpha combined with radiotherapy and pembrolizumab achieved a 50% median tumor hyalinization/fibrosis rate, significantly exceeding the 35% prespecified benchmark.
  • The chemotherapy-free combination therapy showed superior efficacy compared to radiotherapy alone, which typically achieves only 15% tumor hyalinization/fibrosis rates in soft tissue sarcoma patients.
  • The results represent a potential paradigm shift for treating this aggressive orphan cancer, which affects approximately 13,520 new patients annually in the US with limited treatment options and poor prognosis.
  • Full trial results from the 40-patient study are expected to be presented at a medical meeting later this year, adding to Immutep's broader efti clinical program across multiple solid tumor indications.

Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial

NCT06128863Active, Not RecruitingPhase 2
Maria Sklodowska-Curie National Research Institute of Oncology
Posted 7/17/2023

Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

NCT04935177CompletedPhase 3
Hansa Biopharma AB
Posted 10/14/2021

Nuvalent to Present First Clinical Data for Next-Generation ALK Inhibitor NVL-655 at AACR-NCI-EORTC Symposium

OncologyTargeted Therapy
• Nuvalent will present preliminary dose-escalation data from the ALKOVE-1 Phase 1/2 trial of NVL-655, marking the first clinical disclosure for this next-generation ALK inhibitor. • NVL-655 is designed to overcome key limitations of existing ALK inhibitors, including resistance mutations, poor brain penetrance, and CNS adverse events. • The drug targets advanced ALK-positive non-small cell lung cancer and has been engineered to remain active against multiple resistance mutations including the challenging G1202R solvent front mutation. • The presentation will occur at the 35th AACR-NCI-EORTC Symposium in Boston on October 13, 2023, with a planned conference call the same day.

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626RecruitingPhase 1
Nuvalent Inc.
Posted 6/9/2022

Multiple Myeloma Treatment Landscape Shows Promise with Novel Combination Therapies in Recent Clinical Trials

OncologyCAR-T
  • Recent clinical trials demonstrate positive outcomes for multiple myeloma patients using combination therapies including pomalidomide, daratumumab, and novel agents like belantamab mafodotin.
  • Phase 3 studies comparing standard therapies with CAR-T cell therapy (ciltacabtagene autoleucel) are ongoing, with enrollment of 419 patients expected to complete by May 2025.
  • Belantamab mafodotin combinations showed manageable safety profiles in lenalidomide-refractory multiple myeloma patients, with ocular events being controllable through dose modifications.
  • Selinexor-based triplet therapies demonstrated varying response rates, with the 60mg weekly dosing showing superior efficacy compared to 40mg dosing in recent Phase 2 trials.

PSMA PET Imaging Transforms Prostate Cancer Management with Multiple FDA-Approved Agents

Drug ApprovalOncology
  • PSMA PET imaging has revolutionized prostate cancer detection and management, particularly in biochemical recurrence settings, with multiple FDA-approved agents now available including gallium-68 PSMA-11, piflufolastat F 18, and flotufolastat F 18.
  • The newer agent flotufolastat F 18 offers unique advantages in postprostatectomy recurrence scenarios due to its reduced bladder activity, allowing better visualization of potential recurrence in the prostate bed.
  • While PSMA PET has largely replaced fluciclovine F 18, the metabolic tracer still maintains a role in specific scenarios including tumors with low PSMA expression and neuroendocrine differentiation cases.
  • Expert panels emphasize that agent selection often depends on institutional availability and specific clinical contexts, as detection rates and sensitivity remain comparable between different PSMA PET tracers.

FDA Lifts Clinical Hold on Allogene's AlloCAR T Studies After Safety Investigation Clears Manufacturing Process

CAR-TOncology
• The FDA has removed a clinical hold on all five of Allogene Therapeutics' AlloCAR T studies that was imposed in October 2021 following a chromosomal abnormality in a single patient. • A three-month investigation concluded that the chromosomal abnormality was unrelated to Allogene's manufacturing process and had no clinical significance for the patient. • The pivotal phase II trial of ALLO-501A in relapsed/refractory large B-cell lymphoma is scheduled to commence in mid-2022. • Allogene's stock rose over 4% in premarket trading following the announcement of the clinical hold removal.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.