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EMERALD Trial Data Reveals Duration of Prior CDK4/6 Inhibitor Therapy as Key Predictor for Elacestrant Success in ESR1-Mutant Breast Cancer

Drug ApprovalTargeted TherapyPrecision Medicine
  • The EMERALD trial demonstrated that patients with ESR1-mutant metastatic breast cancer who received CDK4/6 inhibitor therapy for more than 12 months achieved significantly better outcomes with elacestrant, with median progression-free survival of 8.6 months versus 3.8 months in optimal patients.
  • Elacestrant maintained efficacy across challenging disease presentations including visceral disease, multiple metastatic sites, and even in patients with traditionally poor prognostic factors like p53 mutations.
  • The FDA has approved elacestrant specifically for ESR1-mutant metastatic breast cancer, with new requirements for lipid profile monitoring before treatment initiation and as needed thereafter.

Molecular Profiling Reduces Radiotherapy Need in Early-Stage Endometrial Cancer

Precision MedicineOncology
  • The PORTEC-4a trial demonstrated that molecular profiling safely reduced radiotherapy need in 46% of women with high-intermediate risk endometrial cancer while maintaining excellent cancer control.
  • Patients with unfavorable molecular profiles who received intensive pelvic radiotherapy showed significantly better outcomes with an 8.4% recurrence rate compared to 30.5% in standard treatment groups.
  • This precision medicine approach represents a major advancement in personalized endometrial cancer treatment, allowing clinicians to tailor therapy based on individual tumor biology and risk profiles.

Dupilumab Shows Sustained Lung Function Improvements in COPD Patients with Type 2 Inflammation

Monoclonal AntibodyPrecision Medicine
  • Pooled data from phase 3 BOREAS and NOTUS trials demonstrate that dupilumab significantly improves lung function in COPD patients with type 2 inflammation, marking a potential advancement in personalized treatment strategies.
  • The monoclonal antibody targets interleukin-4 and interleukin-13 pathways, offering a targeted approach for this specific COPD subgroup that could transform treatment paradigms.
  • Real-world data also show dupilumab provides sustained improvements in severe asthma patients over 2 years, with over half achieving remission within 1-2 years of treatment.

Real-World Study Reveals Biomarker Status Drives Survival and Cost Disparities in Advanced NSCLC

Targeted TherapyPrecision MedicineReal World Evidence
  • A large real-world study of 26,635 advanced NSCLC patients found significant survival differences based on biomarker status, with ALK-positive patients achieving nearly 40 months median survival compared to 12-16 months for those without driver mutations.
  • Medication costs varied substantially by biomarker group, with the average annual treatment cost reaching $120,000 and two-year costs approximately $183,000 across all patients.
  • Patients without driver alterations showed consistently higher "cost per survivor" ratios, requiring about $500,000 to keep one low PD-L1 patient alive for two years versus $363,000 for ALK-positive patients.
  • The findings highlight critical gaps in community biomarker testing, where only 37% of NSCLC patients receive all nine recommended biomarker tests despite 83% having at least one test performed.

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

NCT03456076Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/16/2018

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

NCT04351555Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/16/2020

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

NCT05015010Active, Not RecruitingPhase 2
Gruppo Oncologico Italiano di Ricerca Clinica
Posted 5/20/2021

Sapient Launches DynamiQ: Next-Generation Multi-Omics Platform Set to Transform Drug Discovery and Development

Precision MedicineDrug DiscoveryAI
  • Sapient has launched DynamiQ Insights Engine, an advanced multi-omics and real-world data platform that integrates thousands of protein, metabolite, lipid, and cytokine measures with matched genomic and clinical data.
  • The platform contains data from over 56,000 samples collected across multiple timepoints from diverse individuals, making it one of the most deeply phenotyped longitudinal datasets available for biomarker discovery and drug development.
  • DynamiQ's ability to track molecular changes over time alongside clinical outcomes enables researchers to better understand disease subtypes, predict treatment responses, and identify patients most likely to benefit from specific therapies.

FDA Approves J&J's Akeega for BRCA-Positive Metastatic Prostate Cancer

Drug ApprovalPrecision MedicineOncology
  • Johnson & Johnson received FDA approval for Akeega, a combination tablet containing niraparib and abiraterone acetate, for first-line treatment of adults with BRCA-positive metastatic castration-resistant prostate cancer.
  • The approval is based on the MAGNITUDE phase 3 trial, which demonstrated a 47% improvement in radiographic progression-free survival compared to standard of care in BRCA1/2 mutation patients.
  • The FDA approval restricts Akeega's use to patients with BRCA1 or BRCA2 mutations, affecting 10-15% of mCRPC patients who typically experience poorer outcomes and shorter survival times.
  • Akeega competes with AstraZeneca and MSD's Lynparza combination and Pfizer's Talzenna, all targeting the same BRCA-mutated patient population in the US market.

Tempus Introduces xM Liquid Biopsy Assay to Monitor Immunotherapy Response in Advanced Solid Tumors

Precision Medicine
  • Tempus AI has launched xM for treatment response monitoring (TRM), a liquid biopsy assay designed to detect molecular response to immune-checkpoint inhibitor therapy in advanced solid tumors by tracking circulating tumor DNA dynamics.
  • The assay can detect molecular response to immunotherapy prior to six weeks into treatment, potentially enabling clinicians to optimize therapeutic strategies and stay ahead of disease progression in patients with advanced cancers.
  • Data presented at the 2025 ASCO Annual Meeting demonstrates that longitudinal non-molecular responders are associated with worse survival compared to molecular responders, highlighting the clinical value of molecular response monitoring.
  • The xM for TRM assay is currently available for research use only, with clinical availability expected later in 2025.

Flatiron Health to Showcase AI-Powered Real-World Oncology Data Research at ISPOR 2025

Real World EvidenceAIOncologyPrecision Medicine
• Flatiron Health will present over 15 research studies at ISPOR 2025, demonstrating how machine learning and AI can transform real-world oncology data into valuable evidence for regulatory decisions.
• Key presentations include validation of ML-extracted response data from EHRs, analysis of real-world evidence acceptance by FDA and EMA, and introduction of a novel Japanese breast cancer database.
• The company's research highlights the growing importance of real-world data in complementing traditional clinical trials and informing precision medicine approaches across diverse healthcare systems.

FYR Partners with Mayo Clinic to Develop Blood-Based Biomarkers for Parkinson's Disease Using AI-Enabled Platform

AIPrecision Medicine
  • FYR and Mayo Clinic have entered a collaboration to advance blood-based biomarker research for Parkinson's disease using FYR's AI-enabled EV-Omics platform.
  • The partnership aims to identify biomarkers associated with Parkinson's disease progression and subtypes by analyzing extracellular vesicles from blood samples.
  • FYR's technology enriches brain-derived extracellular vesicles to enhance detection of disease-associated proteins, RNA, and DNA for improved patient outcomes.
  • The collaboration seeks to develop innovative tools that could improve clinical trial results and advance precision care for Parkinson's patients.

Novel AI Model PROGRxN-BCa Significantly Improves NMIBC Progression Risk Prediction

AIOncologyPrecision Medicine
  • A new artificial intelligence model, PROGRxN-BCa, trained on over 12,000 patients, outperforms current guideline-endorsed risk calculators for non-muscle invasive bladder cancer progression by approximately 10%.
  • The model effectively sub-stratifies the heterogeneous intermediate-risk NMIBC patient group into distinct risk tertiles, enabling more personalized treatment approaches based on progression probability.
  • Developed using 14 readily available clinicopathological features, PROGRxN-BCa requires no specialized biomarkers or histopathological slides, making it practical for routine clinical implementation.
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