MedPath

Tagged News

Long-Term Follow-Up of TRANSFORM Trial Shows Sustained Benefits of Liso-Cel CAR T-Cell Therapy in Relapsed LBCL

CAR-TOncologyReal World Evidence
  • Three-year follow-up data from the phase 3 TRANSFORM trial demonstrates lisocabtagene maraleucel (liso-cel) significantly improved event-free survival with a median of 29.5 months versus 2.4 months with standard of care in relapsed large B-cell lymphoma.
  • Liso-cel showed impressive efficacy with an 87% overall response rate and 74% complete response rate, while maintaining a favorable safety profile with lower rates of cytokine release syndrome and neurotoxicity compared to axicabtagene ciloleucel.
  • The study revealed that patients who received liso-cel as second-line therapy had substantially better outcomes than those who crossed over after standard chemotherapy, emphasizing the importance of early CAR T-cell intervention.

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation

NCT04531046Active, Not RecruitingPhase 2
The Lymphoma Academic Research Organisation
Posted 3/10/2021

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Sakar Healthcare Secures Second EU Marketing Authorization for Colorectal Cancer Treatment

OncologyDrug Approval
  • Sakar Healthcare received its second Marketing Authorization from the European Union for an oncology injection product targeting colorectal cancer treatment.
  • The approval follows the company's first EU marketing authorization received in April 2025 for treating breast cancer, non-small cell lung cancer, and prostate cancer.
  • The company has several additional oncology products under EU registration and expects to receive marketing authorizations within the coming months.
  • Sakar's strategic partnership with Accord Healthcare provides access to commercial infrastructure across 45 countries in the EU and UK markets.

Chimeric Therapeutics Raises $6.6 Million to Advance Novel CAR-T and NK Cell Cancer Therapies

CAR-TOncology
  • Chimeric Therapeutics has secured $6.6 million through a two-tranche placement from institutional and professional investors to accelerate its clinical trial pipeline.
  • The funding will primarily support the advancement of CHM CDH17 CAR-T therapy, the first anti-CDH17-directed CAR-T treatment, and CORE-NK cell therapy programs for various cancer types.
  • Patient recruitment and dosing are progressing at major U.S. cancer centers, with the University of Chicago Medicine joining as a new trial site for the pioneering CDH17 CAR-T therapy.

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy

NCT06055439RecruitingPhase 1
Chimeric Therapeutics
Posted 5/15/2024

Parabilis Medicines Demonstrates First-Ever Degradation of ERG in Prostate Cancer Models

Oncology
  • Parabilis Medicines has developed the first-in-class ERG degrader using their proprietary Helicon peptide technology, targeting a previously "undruggable" transcription factor implicated in 40-50% of prostate cancers.
  • Preclinical data presented at AACR 2025 showed >90% tumor ERG degradation in mouse models, with significant tumor growth inhibition in both patient- and cell-line derived xenograft models.
  • The ERG degrader program, currently in late lead optimization with IND-enabling studies planned for 2025, could provide a novel therapeutic approach for patients with metastatic castrate-resistant prostate cancer.

Zai Lab to Present Phase 1 Data on Novel DLL3-Targeted ADC for Small Cell Lung Cancer at ASCO 2025

OncologyTargeted Therapy
  • Zai Lab will showcase updated results from its Phase 1a/1b trial of ZL-1310, a potentially best-in-class DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer at the 2025 ASCO Annual Meeting.
  • The novel ADC utilizes TMALIN® technology platform to overcome limitations of first-generation ADCs by leveraging the tumor microenvironment, with the FDA granting Orphan Drug Designation in January 2025.
  • ZL-1310 combines a humanized anti-DLL3 monoclonal antibody with a novel camptothecin derivative payload, targeting an antigen overexpressed in aggressive neuroendocrine tumors associated with poor outcomes.

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

NCT05152147Active, Not RecruitingPhase 3
Jazz Pharmaceuticals
Posted 12/2/2021

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

NCT05091567Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/18/2021

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

NCT06179069RecruitingPhase 1
Zai Lab (Shanghai) Co., Ltd.
Posted 1/23/2024

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

NCT03929666CompletedPhase 2
Jazz Pharmaceuticals
Posted 8/29/2019

Novita's Fascin Inhibitor NP-G2-044 Shows Promising Results in Phase 2 Trial for Advanced Solid Tumors

Oncology
  • Novita Pharmaceuticals' first-in-class fascin inhibitor NP-G2-044 demonstrated a 21% objective response rate and 76% disease control rate in patients with advanced solid tumors resistant to prior anti-PD-1 therapy.
  • The Phase 2 trial showed durable responses across seven cancer types, with 55% of patients experiencing no new metastases and some responses lasting more than 80 weeks in pancreatic and endometrial cancers.
  • NP-G2-044 targets fascin, a key protein in tumor cell motility, potentially addressing the critical unmet need for therapies specifically targeting cancer metastasis, which causes over 90% of cancer-related deaths.

NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies

NCT05023486RecruitingPhase 1
Novita Pharmaceuticals, Inc.
Posted 12/7/2021

Bayer Partners with ConcertAI to Accelerate Precision Oncology Drug Development Using AI

AIOncologyDrug Discovery
  • Bayer and ConcertAI have entered a multi-year strategic agreement leveraging AI and machine learning to accelerate clinical development in precision oncology.
  • The partnership utilizes ConcertAI's Translational360™ platform, which integrates data from over 9 million cancer patient records across the U.S., combining clinical, genomic, and imaging information.
  • This collaboration aims to enhance drug discovery by using multi-modal data and AI to better predict treatment responses, potentially delivering precision oncology treatments to patients faster.

1Cell.Ai Launches OncoIncytes: Revolutionary Multi-Modal Cancer Diagnostic Panel for Precision Oncology

AIOncology
  • 1Cell.Ai (formerly OneCell Diagnostics) has launched OncoIncytes, a comprehensive multi-modal cancer diagnostic panel that integrates ctDNA, CTCs, RNA transcriptomics, and proteomics data for enhanced precision oncology.
  • The technology employs a 1080 gene panel with AI and machine learning models, offering unprecedented sensitivity to optimize clinical trials, particularly for antibody-drug conjugate development.
  • Following a $16M Series A funding round, the company's rebranding reflects its evolution from genomics-based diagnostics to AI-powered precision oncology solutions aimed at revolutionizing cancer care.

Guardant Health's Shield Multi-Cancer Detection Test Shows Strong Performance Across 10 Cancer Types

Oncology
  • Guardant Health's blood-based Shield Multi-Cancer Detection test demonstrated 98.5% specificity and 60% overall sensitivity across ten tumor types, with particularly strong results for aggressive cancers.
  • The test achieved 89% accuracy for cancer signal of origin prediction, potentially enabling clinicians to identify the primary tumor location through a simple blood draw.
  • Based on these promising results, the National Cancer Institute selected Shield MCD for its upcoming Vanguard Study evaluating emerging multi-cancer detection technologies.

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

NCT04089631RecruitingPhase 3
Technische Universität Dresden
Posted 6/26/2020

Personalis to Present New Data on NeXT Personal ctDNA Test for Early Cancer Detection at Major Oncology Conferences

Oncology
  • Personalis and academic collaborators will showcase new clinical data on their ultrasensitive NeXT Personal ctDNA assay at upcoming AACR and ASCO conferences, demonstrating its application across multiple cancer types.
  • The VICTORI study will present preliminary results on post-surgical minimal residual disease detection in colorectal cancer, while the TRACERx collaboration will share findings from one of the largest ctDNA studies in early-stage lung cancer.
  • New research will expand clinical evidence for NeXT Personal into neoadjuvant treatment settings for breast cancer and cervical cancer, supporting the company's mission to enable earlier detection of residual and recurrent cancer.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.