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myeloMATCH Launches Precision Medicine Trial for Myeloid Cancers

  • The NIH has initiated myeloMATCH, a precision medicine trial, to match AML and MDS patients with treatments based on their cancer's genetic profile.
  • The trial employs rapid genetic testing (within 72 hours) to assign patients to targeted sub-studies or standard treatment, aiming to personalize therapy.
  • myeloMATCH will re-evaluate patients and transfer them to subsequent trials based on genomic data to target residual disease effectively.
  • The initiative includes over 140 clinical sites across the US and Canada, with plans to enroll thousands of patients and expand sub-studies.

Additional BCG Shows High Response Rates in BCG-Exposed and BCG-Unresponsive NMIBC

  • A study at MD Anderson Cancer Center evaluated additional BCG treatment in NMIBC patients, showing high response rates in both BCG-exposed and BCG-unresponsive groups.
  • In BCG-exposed patients, additional BCG resulted in a 79% complete response rate, with a median duration of response of 169 months.
  • For BCG-unresponsive patients, 75% remained disease-free after additional BCG, with a median duration of response of 83 months.
  • The findings suggest additional BCG should be considered as a control arm in clinical trials for BCG-exposed NMIBC patients.

Cybin's Phase 3 Trial of CYB003 for Major Depressive Disorder Faces Delay

  • Cybin Inc. has delayed the start of its Phase 3 clinical trial for CYB003, a potential treatment for Major Depressive Disorder (MDD), missing its late summer 2024 target.
  • The company completed site selection for the Phase 3 trial across the U.S. and Europe, but patient enrollment has not yet commenced.
  • Phase 2 results of CYB003 showed rapid improvement in depression symptoms and a 75% remission rate four months after two doses in the 16mg group, with 12-month data expected in early Q4 2024.
  • Cybin held a Type B meeting with the FDA, incorporating elements to address methodological issues like functional unblinding in the Phase 3 trial design.

Greenwood Genetic Center Appoints Dr. Michael Lyons to Lead Precision Medicine Initiative

  • Dr. Michael Lyons has been appointed as the Ravenel Boykin Curry chair in translational genomics and therapeutics at Greenwood Genetic Center (GGC).
  • Lyons will spearhead the Precision Medicine Initiative at GGC, focusing on translating research discoveries into improved patient care.
  • His role includes overseeing the Genomic Discovery Program and providing leadership for clinical trials aimed at enhancing existing treatments.
  • Dr. Lyons, board-certified in pediatrics and medical genetics, will contribute to GGC's clinical, diagnostic, research, and educational endeavors.

Novo Nordisk's Oral CB1 Blocker Monlunabant Fails in Phase II Obesity Trial

  • Novo Nordisk's oral CB1 receptor blocker, monlunabant, failed to demonstrate significant weight loss in a Phase II obesity trial at 16 weeks.
  • The trial was further impacted by neuropsychiatric adverse events, raising concerns about the drug's safety profile.
  • This setback increases pressure on Novo Nordisk to seek external partnerships or acquisitions to maintain its leading position in the oral obesity therapy market.
  • The failure casts doubt on CB1 as a viable target for obesity treatment, despite initial enthusiasm.

Iomab-B Demonstrates Durable Remission in Phase 3 SIERRA Trial for Relapsed/Refractory AML

  • The Phase 3 SIERRA trial demonstrated that Iomab-B achieved a statistically significant durable Complete Remission (dCR) rate of 22% compared to 0% in the control arm for relapsed/refractory AML patients.
  • Event-Free Survival (EFS), a secondary endpoint, was significantly improved with Iomab-B, showing a Hazard Ratio of 0.22 (p < 0.0001), indicating a substantial reduction in the risk of events.
  • While overall survival (OS) was not met due to a high crossover rate, subgroup analyses showed improved survival in patients with TP53 mutations and those aged 65 and above.
  • Actinium Pharmaceuticals is seeking a strategic partner to conduct an additional Phase 3 trial to demonstrate overall survival benefit, as requested by the FDA for potential BLA filing.

FDA's Project Optimus Reshapes Oncology Drug Development with Focus on Dose Optimization

  • FDA's Project Optimus encourages identifying oncology drug doses that maximize efficacy, safety, and tolerability, moving beyond the traditional 'more is better' approach.
  • The guidance recommends selecting two doses for Phase II trials—the maximum tolerated dose (MTD) and a lower dose—to determine which provides the best balance of efficacy and safety.
  • Implementing Project Optimus poses challenges, including the need for more comprehensive early-phase data and potential enrollment difficulties, especially in rare diseases.
  • Strategies for successful implementation include early engagement with the FDA, gathering diverse expert perspectives, and leveraging data to optimize site selection and trial design.

SBRT vs. Hypofractionated Radiotherapy for Stage I NSCLC: LUSTRE Trial Results

  • The LUSTRE trial compared stereotactic body radiotherapy (SBRT) with hypofractionated conventional radiotherapy (CRT) for Stage I non-small cell lung cancer.
  • The study found no statistically significant difference in local control at 3 years between SBRT and CRT, with SBRT showing 87.6% and CRT 81.2%.
  • Severe toxic effects were limited in both groups, including patients with central tumors, suggesting both treatments are relatively safe.
  • The findings suggest hypofractionated CRT could be a viable alternative to SBRT, especially in resource-limited settings.

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

NCT03924869TerminatedPhase 3
Merck Sharp & Dohme LLC
Posted 6/25/2019

Nanoparticle Therapy Shows Promise in Shrinking Pancreatic Tumors in Mice

  • Researchers at UMass Chan Medical School have developed a nanoparticle therapy that effectively shrinks pancreatic tumors in mice, offering a potential new approach for this deadly cancer.
  • In preclinical trials, the nanoparticle treatment led to significant tumor reduction in eight out of ten mice, with two mice remaining tumor-free for an extended period.
  • The nanoparticles are designed to evade detection in the bloodstream, allowing for more targeted delivery to tumors and activation of the immune system.
  • The research team hopes to advance this therapy to human trials, particularly for patients with late-stage pancreatic cancer who have not responded to conventional treatments.

Verastem Oncology Appoints John Hayslip as Chief Medical Officer

  • Verastem Oncology has appointed John Hayslip, M.D., a seasoned oncologist, as its new Chief Medical Officer to spearhead clinical and medical strategies.
  • Dr. Hayslip will oversee the development programs for avutometinib, including the Phase 3 RAMP 301 clinical trial, and advance other pipeline assets.
  • This appointment follows the departure of Louis J. Denis, M.D., marking a strategic shift in Verastem Oncology's leadership to drive forward its oncology drug development efforts.

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