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Evolving Treatment Landscape for Metastatic Hormone-Sensitive Prostate Cancer: Beyond ADT Monotherapy

Oncology
  • Current 2025 guidelines for metastatic hormone-sensitive prostate cancer (mHSPC) recommend androgen deprivation therapy (ADT) with intensification, marking a significant shift from ADT monotherapy.
  • Multiple evidence-based intensification options including abiraterone, darolutamide, and docetaxel have demonstrated survival benefits and delayed disease progression in key clinical trials such as ARANOTE, ARASENS, and TITAN.
  • Treatment selection can now be tailored based on individual patient characteristics and preferences, with all intensification approaches showing superior outcomes compared to ADT alone.

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

NCT04074746CompletedPhase 1
M.D. Anderson Cancer Center
Posted 7/18/2020

Scientific Breakthrough Reveals How Alpha1H Targets Bladder Cancer Cells

Oncology
  • Hamlet BioPharma and Lund University researchers have discovered that Alpha1H, a bladder cancer drug candidate, targets the endoplasmic reticulum in tumor cells, causing it to collapse like a net around toxic components.
  • The mechanism explains Alpha1H's ability to kill cancer cells while sparing healthy tissue, as it prevents leakage of harmful substances from dying tumor cells into surrounding areas.
  • This breakthrough provides scientific validation for Alpha1H's efficacy and safety profile, strengthening its market position and potential applications in treating the 600,000 people affected by bladder cancer annually.

DexTech Medical Secures European Patent for OsteoDex GMP Manufacturing Until 2045

Oncology
  • DexTech Medical has received European patent approval for the GMP manufacturing process of OsteoDex, their lead candidate for treating castration-resistant prostate cancer.
  • The newly granted patent extends market exclusivity until 2045, significantly strengthening the company's position in ongoing partnership and licensing negotiations.
  • This patent approval represents a critical milestone for the continued clinical development of OsteoDex following its completed Phase 2 trials.

Massalia Therapeutics Launches with Seed Funding to Target Fibrosis-Neoplasm-Neovascularization Interface

Oncology
  • Massalia Therapeutics has launched as a biotechnology spin-off from Aix-Marseille University's C2VN Institute, backed by seed financing to develop its novel SANF factor therapeutic platform.
  • The company's proprietary SANF (Soluble Angiogenic Neoplastic and Fibrotic) factor targets the critical intersection of fibrosis, neoplasm, and neovascularization, representing a potential paradigm shift in treatment approaches.
  • With preclinical testing complete, Massalia plans to begin first-in-human trials within six months and advance toward IND-enabling studies, leveraging 20 years of research by co-founders Dr. Marcel Blot-Chabaud and Professor Nathalie Bardin.

FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm

Drug ApprovalOncologyRare DiseaseAIReal World EvidencePrecision Medicine
  • The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
  • Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
  • Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.

Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer

Oncology
  • The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
  • Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
  • The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

2023-509628-16-00RecruitingPhase 3
Daiichi Sankyo Inc.
Posted 5/21/2024

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

NCT06330064RecruitingPhase 2
Daiichi Sankyo
Posted 4/10/2024

A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

NCT06644781RecruitingPhase 3
Daiichi Sankyo
Posted 3/27/2025

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

NCT06925737RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/13/2025

New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial

OncologyTargeted Therapy
  • A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
  • The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
  • Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.

FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials

Oncology
  • ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
  • The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process.
  • In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.

€13.6M EU-Funded PREDI-LYNCH Project Aims to Transform Cancer Screening for Lynch Syndrome Patients

AIOncology
  • The PREDI-LYNCH project has received €13.6 million in EU funding to develop non-invasive liquid biopsy tests for early cancer detection in Lynch Syndrome carriers, addressing a critical unmet medical need.
  • Swedish diagnostics company Elypta joins 27 partners across 16 European countries in this six-year initiative (2025-2031), contributing its proprietary glycosaminoglycan-based biomarker technology.
  • With only 5% of Europe's estimated 2 million Lynch Syndrome carriers under cancer surveillance, the project aims to create affordable, accessible screening methods for colorectal, endometrial, and urothelial cancers.

Azvudine Shows Comparable Effectiveness to Nirmatrelvir/Ritonavir for COVID-19 Patients with Chronic Liver Disease

Oncology
  • A multicenter retrospective study found that azvudine demonstrated effectiveness comparable to nirmatrelvir/ritonavir in reducing all-cause death and disease progression in COVID-19 patients with pre-existing chronic liver diseases.
  • Azvudine showed superior effectiveness specifically for COVID-19 patients with comorbid primary malignant tumors, potentially offering an alternative treatment option for this vulnerable population.
  • Both antiviral medications demonstrated acceptable safety profiles, with azvudine showing slightly better liver function outcomes in patients with chronic liver disease, providing important clinical guidance for treatment selection.

The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

NCT06349655Completed
The First Affiliated Hospital of Zhengzhou University
Posted 12/5/2023

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