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Real-World Study Shows Safe Rechallenge with Trastuzumab Deruxtecan After Grade 1 Interstitial Lung Disease

Real World Evidence
  • A multi-institutional study of 1,476 patients found that 75% of those with grade 1 interstitial lung disease (ILD) were successfully rechallenged with trastuzumab deruxtecan, remaining on therapy for a median of 215 days.
  • Patients treated with steroids for grade 1 ILD showed significantly faster radiographic improvement (29 days vs 82 days without steroids), supporting early steroid intervention.
  • Only 27% of rechallenged patients developed recurrent ILD, mostly grade 1, with no deaths from ILD after rechallenge, demonstrating the safety of this approach.
  • The study provides real-world evidence supporting rechallenge protocols for grade 1 ILD, potentially maximizing clinical benefit from this pivotal HER2-targeted therapy.

Hedera Dx Secures €15 Million Series A to Expand Decentralized Liquid Biopsy Platform Across Europe

Real World Evidence
  • Hedera Dx raised €15 million in Series A funding led by Vsquared Ventures to expand its hospital-based liquid biopsy testing platform across Europe.
  • The company's decentralized model enables hospitals to perform advanced blood-based cancer diagnostics in-house, reducing turnaround time from 10-14 days to under 48 hours.
  • Hedera's platform is already deployed in hospital labs across 11 European countries and includes a comprehensive 32-gene circulating tumor DNA panel with cloud-based analytics.
  • The funding will accelerate commercial expansion and development of new assays for minimal residual disease and early detection while enhancing the company's real-world data capabilities.

Real-World Evidence Guides Extended Dosing Strategies for Next-Generation Anti-VEGF Therapies in Retinal Disease

Real World Evidence
  • Retinal specialists are successfully extending treatment intervals beyond traditional 12-week limits with newer anti-VEGF agents like faricimab and aflibercept 8 mg, with some physicians comfortable reaching 16-20 weeks in appropriate patients.
  • Real-world data reveals that switching from aflibercept 2 mg to 8 mg typically allows 2-4 week extensions in treatment intervals, with benefits improving over time rather than immediately after switching.
  • Patient compliance drops significantly beyond 4-month intervals, leading physicians to identify a "sweet spot" of 3-4 month treatment cycles that balance disease control with patient convenience.
  • Loading dose strategies differ between treatment-naive and previously treated patients, with complete reloading often unnecessary when switching to newer agents in experienced patients.

Beyfortus Demonstrates Superior Real-World Efficacy Against RSV Compared to Maternal Vaccination

Monoclonal AntibodyReal World Evidence
  • Sanofi's Beyfortus reduced infant RSV hospitalizations by 69% in Spain's immunization program, significantly outperforming the UK's maternal RSVpreF vaccination program which achieved only 26.7% reduction.
  • New durability data from the HARMONIE Phase 3b study show Beyfortus maintained 82.7% efficacy against RSV hospitalizations through six months, exceeding the typical five-month RSV season length.
  • The REACH study represents the first multi-country public health impact analysis comparing different RSV prevention strategies, providing crucial real-world evidence for infant immunization programs.
  • With over six million infants immunized across 40 studies spanning four continents, Beyfortus has established the largest body of real-world evidence for infant RSV protection.

British Columbia Biosimilar Policy Shows No Impact on Healthcare Utilization for Inflammatory Arthritis Patients

Real World Evidence
  • A population-based study of 3,004 inflammatory arthritis patients in British Columbia found no significant differences in healthcare utilization between those prescribed etanercept biosimilars versus originators following a 2017 policy mandate.
  • The policy requiring new etanercept prescriptions to use biosimilars increased biosimilar uptake from 0.06% to 78.3% without affecting hospitalization rates, emergency visits, or physician encounters over three years.
  • Using regression discontinuity design as a natural experiment, researchers demonstrated equivalent real-world effectiveness and safety of biosimilars compared to originator biologics in routine clinical practice.
  • The findings provide evidence to address healthcare provider and patient concerns about biosimilar effectiveness, supporting broader adoption of cost-effective biosimilar therapies for inflammatory arthritis treatment.

BD Launches XTRACT Registry to Evaluate Real-World Outcomes of Rotarex Atherectomy System in Peripheral Artery Disease

Real World Evidence
  • BD announced the initiation of the XTRACT Registry, a prospective multi-center study to assess real-world clinical performance of the Rotarex™ Atherectomy System in treating U.S. patients with peripheral artery disease.
  • The registry will enroll up to 600 patients at approximately 100 clinical sites across the United States, with clinical follow-up evaluations at 30 days, 6 months, and 12 months post-procedure.
  • Peripheral artery disease affects more than 21 million Americans and 200 million people worldwide, potentially leading to cardiovascular complications and lower limb amputation.
  • The Rotarex™ Atherectomy System offers dual indications as both an atherectomy and thrombectomy device for minimally invasive removal of plaque and thrombus in peripheral arteries.

Real-World Study Reveals 60% of Eligible Patients Not Receiving Adjuvant Abemaciclib for High-Risk Early Breast Cancer

Real World Evidence
  • A nationwide US study found that 60% of patients with high-risk HR+/HER2- early breast cancer who met eligibility criteria for adjuvant abemaciclib did not receive this FDA-approved therapy.
  • Older patients and those with N1 disease plus high-risk features were most likely to miss out on treatment, despite similar efficacy and safety profiles demonstrated in clinical trials.
  • Among patients who did receive abemaciclib, real-world data showed an 81.6% persistence rate at 3 months, suggesting good tolerability in routine clinical practice.
  • The treatment gap highlights the need for improved education about recurrence risk and consistent benefits of adjuvant abemaciclib to optimize outcomes and prevent metastatic disease.

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/12/2017

Real-World Study Reveals Lower Immune-Related Adverse Events in Latin American Liver Cancer Patients Treated with Atezolizumab-Bevacizumab

Monoclonal AntibodyOncologyReal World Evidence
  • A multinational study of 99 Latin American patients with unresectable hepatocellular carcinoma found only 18% experienced immune-related adverse events (irAEs) with atezolizumab-bevacizumab therapy, significantly lower than clinical trial rates.
  • Most irAEs were mild to moderate, primarily affecting the liver and thyroid, with half resolving within 30 days and only eight patients requiring steroid treatment.
  • Patients with elevated baseline alpha-fetoprotein levels (≥400 ng/mL) showed significantly higher risk for developing irAEs, potentially serving as a predictive biomarker.
  • The occurrence of immune-related side effects did not impact overall survival, with both groups achieving identical median survival of 18.5 months.

MAHA Commission Proposes Comprehensive Pediatric Drug Safety Research Initiative

Real World Evidence
  • The MAHA Commission has outlined an enhanced research framework focused on drug safety in pediatric populations, addressing critical gaps in current safety monitoring systems.
  • The initiative includes plans for reproducing industry-sponsored studies, implementing robust postmarket surveillance programs, and conducting comprehensive long-term outcome assessments.
  • Research priorities emphasize neurodevelopmental and metabolic outcomes for commonly prescribed pediatric medications, reflecting growing concerns about long-term effects in developing populations.
  • The proposal represents a significant shift toward independent verification of pediatric drug safety data and enhanced monitoring of real-world outcomes in children.

Flatiron Health to Present 14 Real-World Oncology Data Studies at ASCO 2025

AIReal World EvidenceOncology
  • Flatiron Health will showcase 14 abstracts at ASCO 2025, leveraging AI and real-world data from over five million cancer patients to generate actionable evidence for improved cancer care.
  • Key research includes the largest real-world study of ctDNA testing in early-stage breast cancer, an assessment of racial disparities in PSMA-PET scan usage for prostate cancer patients, and innovations in clinical trial enrollment.
  • The company's research aligns with ASCO's 2025 theme "Driving Knowledge to Action: Building a Better Future" by using advanced machine learning and AI to transform patient experiences into knowledge for a more connected oncology ecosystem.
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