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Clinical Trial News

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

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.

Breakthrough Immunotherapy Combination Shows Promise Against Common Colorectal Cancer in Phase 1 Trial

Monoclonal Antibody
  • A phase 1 trial of 148 patients demonstrated that the combination of botensilimab and balstilimab immunotherapy drugs successfully treated microsatellite stable metastatic colorectal cancer, the most common form that has historically not responded to immunotherapy.
  • The study found that 61% of patients experienced tumor shrinkage or stabilization after six months of treatment, marking the first time consistent and durable responses to immunotherapy have been reported in this difficult-to-treat patient population.
  • The treatment was well-tolerated with common side effects including diarrhea and fatigue, and showed particular effectiveness in patients without liver metastases.
  • Agenus Inc. is planning to seek FDA approval and has initiated a phase 3 clinical trial, potentially offering new hope for colorectal cancer patients who face limited treatment options.

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272Active, Not RecruitingPhase 1
Agenus Inc.
Posted 3/20/2019

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.

Biophytis Receives FDA Approval for Phase 2 Obesity Trial of BIO101 to Address Muscle Loss in GLP-1 Therapy

  • Biophytis has received FDA IND approval for a phase 2 clinical study evaluating BIO101 (20-hydroxyecdysone) in obesity patients to preserve muscle strength and function.
  • The study aims to address muscle mass loss associated with incretin-based therapies like GLP-1 receptor agonists, with primary endpoint measuring lower limb muscle strength improvement.
  • The multicenter trial will begin mid-2024 in the USA with potential European expansion, targeting a rapidly growing obesity treatment market projected to reach $100 billion by 2030.

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.

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™).

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

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

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

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