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Clinical Trial News

WU-CART-007 Shows Promise in Relapsed/Refractory T-ALL/LBL

  • WU-CART-007 (W-T7), an off-the-shelf, allogeneic, CD7-targeted CAR T-cell therapy, demonstrates high efficacy in relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).
  • The Phase 2 trial of W-T7 showed a 91% overall response rate and a 73% composite complete remission rate in heavily pretreated patients.
  • Treatment-related adverse events were manageable, with most CRS cases being grade 1 or 2, and resolved with supportive care.
  • A registration study with two arms is being designed to further evaluate W-T7 in relapsed/refractory and MRD relapsed/refractory T-cell ALL, potentially leading to FDA approval.

Pozelimab and Cemdisiran Combination Shows Superior Hemolysis Control in PNH Patients

  • A Phase 3 trial of pozelimab and cemdisiran (poze-cemdi) demonstrated superior control of intravascular hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) patients compared to ravulizumab.
  • 96% of patients on poze-cemdi achieved adequate lactate dehydrogenase (LDH) control, a key hemolysis marker, versus 80% on ravulizumab, indicating greater disease management.
  • The poze-cemdi combination provided complete and uninterrupted inhibition of terminal complement, with potential for less frequent subcutaneous administration.
  • Switching from ravulizumab to poze-cemdi in an open-label extension study led to improved LDH control in patients who had previously failed to achieve adequate control.

Acalabrutinib, Venetoclax, and Obinutuzumab Show Promise in High-Risk CLL

  • Acalabrutinib, venetoclax, and obinutuzumab (AVO) demonstrate high activity and tolerability in treatment-naïve chronic lymphocytic leukemia (CLL) patients, including those with TP53 aberrations.
  • The combination therapy achieved a 42% complete remission rate with undetectable measurable residual disease (uMRD) in both TP53-aberrant and all-comer CLL patient groups.
  • After a median follow-up of 55.2 months, the four-year progression-free survival was 70% for patients with TP53 aberration and 96% for those without, suggesting a potential new standard of care.
  • The AVO regimen showed infrequent cardiovascular toxicities and bleeding complications, indicating a favorable safety profile in this high-risk patient population.

Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

NCT03580928Active, Not RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 8/7/2018

Tirzepatide Shows Promise in Treating Obstructive Sleep Apnea in Phase III Trial

  • Eli Lilly's tirzepatide significantly reduced sleep apnea events in obese adults during a Phase III trial, with about 30 fewer disruptive events per hour of sleep.
  • Over 50% of patients using PAP therapy achieved disease resolution with tirzepatide, prompting Lilly to seek FDA approval for moderate-to-severe OSA and obesity.
  • Analysts project peak sales of tirzepatide to reach $25 billion if approved for OSA, further solidifying its position in the GLP-1 market alongside Novo Nordisk's semaglutide.
  • Lilly's pipeline success, including potential blockbuster donanemab for Alzheimer's, contributes to strong financial performance and optimistic analyst outlook.

Uncommon Cures Aims to Revolutionize Rare Disease Clinical Trials with Novel Approach

  • Uncommon Cures, a clinical trial program, addresses the unmet needs in rare disease research by offering a concierge-based, regulatory-grade trial model.
  • The company's approach focuses on adaptive trial designs, minimizing patient burden, and leveraging decentralized components to improve recruitment and data quality.
  • Uncommon Cures reports substantial cost savings (over 40%) and reduced timelines compared to traditional CRO models, attracting interest from diverse sponsors.
  • By expanding internationally and fostering collaboration, Uncommon Cures seeks to improve the success rate of rare disease trials and accelerate therapy development.

GenAI Poised to Transform Pharmaceutical Medical Writing Despite Implementation Challenges

  • Over 57% of pharmaceutical companies plan to invest in medical writing technology, with AI data extraction and information summarization identified as key priority areas for development.
  • A significant capability gap exists as 53% of pharma organizations lack sufficient internal knowledge to implement AI technologies, highlighting the need for strategic partnerships.
  • GenAI shows promise in streamlining regulatory documentation and clinical report writing, though successful implementation requires careful consideration of data security, regulatory compliance, and human oversight.

Amivantamab Plus Lazertinib Shows Superior PFS Over Osimertinib in EGFR-Mutated NSCLC

  • The combination of amivantamab and lazertinib significantly improved progression-free survival (PFS) compared to osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
  • The phase 3 MARIPOSA trial demonstrated a statistically significant and clinically meaningful PFS benefit with the amivantamab/lazertinib regimen versus osimertinib monotherapy.
  • The safety profile of the amivantamab and lazertinib combination was consistent with previously reported data, suggesting a manageable safety profile.
  • Ongoing overall survival (OS) analyses are planned to further evaluate the clinical significance of the amivantamab/lazertinib combination compared to osimertinib.

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

mRNA Cancer Vaccines Show Promise in Clinical Trials, First Approval Expected by 2029

  • Over 60 mRNA cancer vaccines are currently in clinical trials, with the most advanced candidate, Moderna and Merck’s mRNA-4157, in Phase 3 for solid malignancies.
  • mRNA vaccines offer a personalized approach to cancer treatment by delivering genetic instructions to cells, prompting an immune response against tumor-associated antigens.
  • The first commercial mRNA cancer vaccine is anticipated to be approved by 2029, potentially generating initial yearly revenues of approximately US$ 100 million.
  • Cumulative sales of mRNA cancer vaccines are predicted to reach US$ 5 billion during the first five years of commercialization, highlighting the significant market potential.

Spectral Medical Appoints MNP as New Auditor, Replacing PwC

  • Spectral Medical Inc. has appointed MNP LLP as its new auditor, succeeding PricewaterhouseCoopers LLP (PwC), effective immediately.
  • The change in auditors was approved by Spectral's Finance & Audit Committee and board of directors following a comprehensive bidding process.
  • PwC's resignation was not due to any disagreements on accounting principles, financial disclosures, or auditing scope with Spectral Medical.
  • Spectral is advancing its Phase 3 trial for Toraymyxin™ (PMX) in septic shock, guided by its Endotoxin Activity Assay (EAA™).
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