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Clinical Trial News

MRD Negativity as a Surrogate Endpoint for PFS in Multiple Myeloma

  • Achieving minimal residual disease (MRD) negativity is increasingly recognized as a crucial endpoint in multiple myeloma treatment, indicating deeper remission and improved outcomes.
  • Meta-analysis of six randomized clinical trials suggests that MRD status could serve as a surrogate endpoint for progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM).
  • The FDA is considering MRD negativity as a potential surrogate endpoint for accelerated drug approval, which could expedite the development of more effective therapies.
  • Studies show that patients achieving MRD-negative complete response (CR) experience superior survival outcomes compared to those with MRD-positive CR, highlighting the importance of MRD monitoring.

Exploring Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrent Treatment with Chemoradiotherapy for Locally Advanced Cervical Cancer

A clinical trial, NRG Oncology GY017, investigates the use of Anti PD-L1 (atezolizumab) as an immune primer and concurrently with extended field chemoradiotherapy for node-positive locally advanced cervical cancer. This study aims to address the unmet need for therapeutic options in patients with para-aortic lymph node metastases, focusing on the synergistic effects of immunotherapy and radiation. The trial explores the optimal sequencing of atezolizumab and chemoradiation to enhance immune activation and improve clinical outcomes.

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

NCT02488759CompletedPhase 1
Bristol-Myers Squibb
Posted 10/13/2015

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)

NCT02054806CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 2/17/2014

FDA Unveils Historic Drug Import Plan from Canada to Combat High US Prices

  • The Trump administration has proposed a groundbreaking plan allowing states, wholesalers, and pharmacies to import certain prescription drugs from Canada to reduce US drug prices.
  • The FDA's new draft guidance enables drug manufacturers to import FDA-approved medications manufactured abroad, though biologics, controlled substances, and certain injectable drugs are excluded.
  • Implementation faces significant challenges, including Canada's concerns about potential domestic shortages and former FBI director Louis Freeh's warnings about enforcement capabilities.

Biogen's Alzheimer's Drug in Spotlight Following Sarepta's Vyondys 53 Approval

The unexpected FDA approval of Sarepta Therapeutics' Vyondys 53 for Duchenne muscular dystrophy has sparked discussions about the potential flexibility the FDA might show towards Biogen's Alzheimer's drug, aducanumab. This comes amidst skepticism over the efficacy and safety of both drugs, with Biogen's application based on a controversial Phase 3 study.

Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer

Monoclonal AntibodyOncologyDrug ApprovalTargeted Therapy
• The APHINITY trial's 6-year analysis reveals that adjuvant pertuzumab with trastuzumab plus chemotherapy improved overall survival by 0.9% in HER2-positive early breast cancer patients, though not reaching statistical significance.
• Patients with node-positive disease showed the most significant benefit from the pertuzumab regimen, with a 4.5% absolute improvement in invasive disease-free survival at 6 years compared to placebo.
• The pertuzumab combination maintained a favorable cardiac safety profile with severe cardiac events occurring in less than 1% of patients, supporting its continued use in high-risk HER2-positive early breast cancer.

Sanofi Pivots R&D Strategy, Discontinues Diabetes Research to Focus on Novel Therapeutics

• Sanofi announces major strategic shift, discontinuing diabetes and cardiovascular R&D while prioritizing six potentially transformative therapies and its successful Dupixent franchise.
• The company's pipeline now features promising candidates including fitusiran for hemophilia, venglustat for rare diseases, and novel treatments for breast cancer and multiple sclerosis.
• Strategic realignment expected to generate €2 billion in cost savings, enabling increased investment in pipeline development and wider profit margins.

Tech-Enabled Solutions Target Racial Disparities in Clinical Trial Participation

  • Less than 3% of eligible US patients participate in clinical trials, with even lower rates among ethnic minorities, highlighting a critical gap in medical research representation.
  • Reveles Clinical Services partners with Black Men in White Coats to increase diversity among principal investigators, addressing trust barriers in minority communities.
  • Decentralized clinical trials utilizing telehealth, wearables, and remote monitoring are being implemented to overcome geographical and access barriers for underserved populations.

UK NHS PROGRESS Trial Shows 95% of Patients Carry Genetic Variants Affecting Drug Metabolism

Precision Medicine
  • The UK National Health Service's PROGRESS trial found that 95% of 500 patients tested carried genetic variants that directly influence how they metabolize common medications.
  • One in four patients had their prescriptions adjusted based on genetic test results, leading to safer and more effective treatments.
  • The trial demonstrates the clinical value of pharmacogenomic testing in improving prescribing precision and patient outcomes.

Early Disease Screening Programs Show Significant Impact on Chronic Disease Prevention

  • Annual health screenings identified 1,185 previously unrecognized cases of prediabetes, 287 cases of diabetes, and 73 cases of chronic kidney disease per 10,000 people screened.
  • Early detection and appropriate medical care could prevent 210 diabetes cases and delay 34 cases of end-stage kidney disease over 5 years per 1,000 cases identified.
  • Employer-sponsored screening programs demonstrate potential for substantial healthcare cost savings through early disease identification and intervention.

Apple Launches Research App with Three Major Health Studies Focusing on Women's Health, Heart Disease, and Hearing

  • Apple has introduced its Research app in the US, enabling iPhone and Watch users to participate in studies on women's health, cardiovascular conditions, and hearing impacts, with leading research institutions.
  • The women's health study, partnering with Harvard University and NIEHS, will investigate connections between menstrual cycles and conditions like PCOS, while the heart study with Brigham and Women's Hospital will monitor for AFib and heart disease.
  • The app emphasizes data privacy and user control, allowing participants to manage their data sharing preferences while contributing to multiple studies simultaneously through a unified platform.

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