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Clinical Trial News

Lecanemab Approved in UK Amidst NICE Hesitation Over Efficacy and Cost

• The UK MHRA has approved lecanemab for early-stage Alzheimer's patients with limited APOE4 gene copies, amidst ongoing debate about its clinical and economic value. • NICE issued draft guidance against NHS use, citing small treatment effects, long-term uncertainties, and economic model concerns, requesting further data from Eisai. • The decision has sparked controversy, highlighting the conflict between high expectations for Alzheimer's treatments and the reality of modest benefits, safety risks, and high costs. • Experts emphasize the need to communicate the true magnitude of lecanemab's treatment effects, considering both clinical outcomes and economic implications for healthcare systems.

NUBEQA Plus ADT Demonstrates 46% Risk Reduction in Metastatic Hormone-Sensitive Prostate Cancer

• The Phase III ARANOTE trial revealed that NUBEQA (darolutamide) combined with ADT significantly reduced the risk of progression or death by 46% in mHSPC patients. • NUBEQA plus ADT showed a statistically significant improvement in radiological progression-free survival (rPFS) compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001). • Bayer plans to submit the ARANOTE data to the FDA to expand NUBEQA's label for use in metastatic hormone-sensitive prostate cancer (mHSPC) treatment. • The safety profile of NUBEQA remained consistent with previous studies, with no new safety signals observed in the ARANOTE trial.

Elacestrant Plus Abemaciclib Shows Promise in Pretreated ER+/HER2- Metastatic Breast Cancer

  • The combination of elacestrant and abemaciclib demonstrates clinical activity in patients with ER-positive, HER2-negative metastatic breast cancer who have received prior treatments.
  • The phase 1b/2 ELECTRA trial reported an objective response rate of 26% among evaluable patients treated across three cohorts, including one complete response.
  • The combination therapy was well-tolerated, with no grade 4 adverse effects reported and neutropenia primarily attributed to abemaciclib's known safety profile.
  • The recommended phase 2 dose was determined to be 345 mg of elacestrant daily plus 150 mg of abemaciclib twice daily, based on safety and efficacy data.

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer

NCT05386108RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 8/31/2022

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

NCT03778931CompletedPhase 3
Stemline Therapeutics, Inc.
Posted 5/10/2019

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT05563220RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 1/24/2023

Low-Dose Aspirin Evaluated for Gastric Cancer Prevention in High-Risk Iranian Population

  • A phase III randomized controlled trial is underway in Iran to assess the effectiveness of long-term, low-dose aspirin in preventing gastric cancer.
  • The study aims to enroll 21,000 participants aged 35-70 in Ardabil, a region with a high incidence of gastric cancer and H. pylori prevalence.
  • Participants will receive either 81 mg of enteric-coated aspirin or a placebo daily for 10 years, with outcomes measured 5 years after treatment.
  • The primary outcome is the difference in the cumulative incidence rate of gastric cancer between the aspirin and placebo groups.

Montreal Children's Hospital Receives $1 Million Boost for Pediatric Cancer Clinical Trials

  • The Montreal Children's Hospital Foundation received a $1 million donation to double pediatric cancer clinical trials by 2027, offering hope for children with rare and aggressive cancers.
  • Clinical trials provide access to experimental treatments that could improve survival rates and reduce the harsh side effects of current treatments for young patients.
  • The donation will expedite the opening of new trials, focusing on targeted drugs for specific genetic mutations and attracting pharmaceutical industry sponsors.
  • The funds have already facilitated the hiring of a research nurse mentor and research pharmacy support to enhance clinical trial management and patient safety.

BioPharma Services Expands into Late-Stage Trials with AI Integration

  • BioPharma Services is expanding into late-stage patient trials by integrating Canadian Phase Onward (CPO), enhancing its clinical trial capabilities.
  • The integration allows BioPharma to offer comprehensive clinical trial services across all phases of drug development, becoming a full-service CRO.
  • HEALWELL AI's platform will be integrated to expedite patient trials through advanced data science and AI-powered patient identification.
  • BioPharma has completed over 2,200 clinical trials with approximately 250 pharma clients, including major global pharmaceutical companies.

Global Superbug Crisis: AMR Deaths Projected to Reach 39 Million by 2050, Lancet Study Warns

• A landmark study published in The Lancet reveals antimicrobial resistance could directly cause 39 million deaths worldwide by 2050, with an additional 169 million deaths strongly associated.
• MRSA emerges as the deadliest superbug, with associated deaths more than doubling from 261,000 in 1990 to 550,000 in 2021, highlighting the growing threat of antimicrobial resistance.
• While AMR-related deaths in children under five have decreased by 50%, elderly populations have seen an 80% increase, with South Asia and Sub-Saharan Africa projected to bear the highest future burden.

Shortwave Life Sciences' Psilocybin Combination Shows Positive Pre-Clinical Safety Results for Anorexia Treatment

  • Shortwave Life Sciences reports positive pre-clinical safety results for its psilocybin-based combination drug aimed at treating anorexia nervosa.
  • The study, conducted with Science in Action, showed no adverse effects in rats at elevated doses of the drug administered buccally.
  • This milestone supports Shortwave's advancement towards human trials and validates its patent-pending buccal delivery system for mental health treatments.
  • The company's approach targets rapid drug absorption, bypassing liver and gut degradation, potentially transforming treatment for metabolic and psychiatric challenges.

Egetis Therapeutics Files Patent for Tiratricol Production Process

  • Egetis Therapeutics has submitted a patent application to the USPTO for novel processes of preparation for tiratricol.
  • The new synthetic routes aim to enhance the efficiency of tiratricol production to meet growing demands.
  • Tiratricol is currently in clinical trials for MCT8 deficiency, with a marketing authorization application submitted in the EU.
  • If granted, the patent would provide Egetis with an exclusivity term of 20 years from the filing date.

Flatiron Health Aims to Boost Clinical Trial Access Through Pragmatic Design and Technology

• Flatiron Health study reveals community practices face resource barriers in offering oncology clinical trials, impacting patient access and representation. • Technology, particularly EHR integration, is identified as key to streamlining trial operations, reducing data entry burdens, and improving efficiency. • Flatiron Health advocates for pragmatic trial designs with broader eligibility and less extraneous data collection to better reflect routine care. • The company collaborates with the FDA and NCI to promote pragmatic trials and enhance data utilization for improved clinical research outcomes.

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