MedPath

Clinical Trial News

ADC Plus ICI Combination Shows Promise in Cancer Treatment: Meta-Analysis

  • A meta-analysis of 12 clinical trials with 584 patients reveals that combining antibody-drug conjugates (ADCs) with immune checkpoint inhibitors (ICIs) yields a pooled objective response rate (ORR) of 58%.
  • The combination therapy demonstrates acceptable adverse events (AEs), primarily related to the skin and digestive system, suggesting a manageable safety profile.
  • Subgroup analysis indicates that certain histologic subtypes, such as Hodgkin lymphoma (HL), benefit most from the combination, potentially linked to high expression of targeted antigens like CD30 and PD-L1.
  • The study emphasizes the importance of patient stratification based on biomarkers and antigen levels to optimize treatment strategies and improve clinical efficacy in ADC and ICI combination therapies.

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT01896999Active, Not RecruitingPhase 1
National Cancer Institute (NCI)
Posted 3/7/2014

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

NCT04740918TerminatedPhase 3
Hoffmann-La Roche
Posted 6/7/2021

aTyr Pharma's Efzofitimod Shows Promise in Pulmonary Sarcoidosis and SSc-ILD Trials

  • aTyr Pharma's Efzofitimod (Efzo) phase III EFZO-FIT study, which targets pulmonary sarcoidosis (PS), has completed enrollment, showing strong interest from patients and physicians.
  • The phase II EFZO-CONNECT trial, evaluating Efzo in systemic sclerosis-related interstitial lung disease (SSc-ILD), is progressing towards its enrollment target, with interim data expected in Q2 2025.
  • Analysts maintain a positive outlook on aTyr Pharma, citing critical readouts for pulmonary sarcoidosis data expected in Q3 2025, which could be transformative for the company.
  • Positive outcomes from clinical trials could significantly boost aTyr's market position, potentially leading to rapid adoption of Efzo and attracting partnership opportunities.

Galectin-9 Identified as Novel Biomarker for Acute-on-Chronic Liver Failure

  • A recent study identifies Galectin-9 (Gal-9) as a potential biomarker for hepatitis B virus-associated acute-on-chronic liver failure (HBV-ACLF).
  • Plasma Gal-9 levels are significantly elevated in HBV-ACLF patients compared to those with chronic hepatitis B (CHB), indicating its diagnostic value.
  • Gal-9 expression correlates with the severity and prognosis of HBV-ACLF, showing potential as a prognostic marker.
  • Combining Gal-9 with the MELD score enhances the prediction of patient outcomes in HBV-ACLF, improving risk stratification.

Biosimilars Generate $12.3 Billion in Healthcare Savings for 2023, Yet Market Challenges Persist

  • Biosimilar medications delivered $12.4 billion in savings during 2023, contributing to a total of $36 billion in cost reductions since their 2015 market introduction.
  • Despite accounting for 90% of U.S. prescriptions, generic and biosimilar medicines represent only 13.1% of prescription drug spending and 1.2% of total healthcare expenditure.
  • Market analysis reveals biosimilars maintain less than 20% market share, with experts calling for regulatory reforms to address patent barriers and streamline FDA approval processes.

PAS-004 Shows Favorable Safety and Early Efficacy in MAPK-Driven Solid Tumors

  • PAS-004, a next-generation MEK inhibitor, demonstrates a tolerable safety profile in early phase 1 trial cohorts of patients with advanced MAPK-driven cancers.
  • The trial observed no drug-related serious adverse effects or dose interruptions at 2 mg and 4 mg doses, with no reports of rash, gastrointestinal, or ocular toxicities.
  • Pharmacokinetic data reveals a long half-life of approximately 70 hours and a flat pharmacokinetic curve at steady-state, potentially enabling constant target inhibition.
  • Early signs of efficacy were observed in a heavily pretreated patient with BRAF K601E-mutated colorectal cancer, showing prolonged stable disease during treatment.

PAS-004 in Patients With Advanced Solid Tumors

NCT06299839RecruitingPhase 1
Pasithea Therapeutics Corp.
Posted 2/29/2024

Stem Cell Transplant Reverses Type 1 Diabetes in World-First Clinical Trial

  • A 25-year-old Chinese woman with type 1 diabetes achieved insulin independence after receiving a stem cell transplant, marking a potential breakthrough in diabetes treatment.
  • The patient's own cells were reprogrammed into induced pluripotent stem cells (iPSCs) and then differentiated into functional islet cells, which were transplanted into her abdomen.
  • Following the transplant, the patient's blood sugar levels stabilized, and she no longer required insulin injections, maintaining a non-diabetic glycemic range for over a year.
  • This success builds on previous stem cell research for both type 1 and type 2 diabetes, offering hope for personalized cell therapies to treat this chronic condition.

Oral Microbiome Linked to Increased Risk of Head and Neck Cancer

  • Researchers found certain oral bacteria are linked to a 50% increased risk of head and neck squamous cell carcinoma (HNSCC).
  • Thirteen bacterial species were identified as influencing the risk of head and neck squamous cell carcinoma (HNSCC).
  • Tirzepatide shows promise in reducing hospitalization and death from heart failure in obese patients with HFpEF.
  • Soy consumption does not increase breast cancer risk and may even reduce it, contrary to previous concerns about isoflavones.

Lundbeck Presents Promising Data on Amlenetug for Multiple System Atrophy at MDS Congress

  • Lundbeck presented data from the TALISMAN natural history study, enhancing the understanding of Multiple System Atrophy (MSA) progression in early-stage patients.
  • The AMULET trial of amlenetug (Lu AF82422) in MSA showed a consistent slowing of clinical progression, with a post-hoc analysis revealing a 42% slowing in a less impaired subgroup.
  • Based on the AMULET trial's encouraging results, Lundbeck is set to initiate a Phase III trial of amlenetug at the beginning of 2025, marking a significant step in MSA treatment.
  • Amlenetug (Lu AF82422), a human monoclonal antibody, targets extracellular α-synuclein, potentially preventing uptake and inhibiting aggregation in MSA patients.

A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476Active, Not RecruitingPhase 2
H. Lundbeck A/S
Posted 11/16/2021

FDA Lifts Clinical Holds on Rezolute's Ersodetug (RZ358) for Congenital Hyperinsulinism

  • The FDA has lifted partial clinical holds on Rezolute's ersodetug (RZ358), allowing clinical trials to proceed at all doses for patients older than three months in the U.S.
  • Patient enrollment for the sunRIZE trial outside the U.S. is nearly complete, with over 90% of patients enrolled in Europe, Asia, and the Middle East, and completion expected by the end of 2024.
  • Rezolute anticipates filing a New Drug Application (NDA) with the FDA in the second quarter of 2026, with a possible market introduction in 2027, following the inclusion of U.S. patients in trials.
  • H.C. Wainwright maintains a Buy rating on Rezolute with a $14 price target, citing the strategic importance of including U.S. patients to de-risk the regulatory pathway.

Digital Decentralized Trials Show Promise in Long COVID Study

  • A feasibility study of digital decentralized clinical trials (DCTs) for Long COVID recruited 85 participants, demonstrating the potential for remote trial designs.
  • The study identified challenges in recruitment, including imposter participants motivated by incentives, highlighting the need for robust verification processes.
  • Qualitative feedback indicated that participants found the digital platform user-friendly, but improvements are needed in notification systems and questionnaire design.
  • DCTs, utilizing platforms like Atom5™, offer a promising avenue for conducting research and gathering patient-reported outcomes in Long COVID and similar conditions.

Trending News

1

AbbVie Acquires In Vivo CAR-T Developer Capstan Therapeutics for Up to $2.1 Billion

a day ago
2

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

a day ago
3

Klotho Neurosciences Advances Gene Therapy Manufacturing for ALS Treatment

2 days ago
4

FDA Approves Takeda's GAMMAGARD LIQUID ERC, First Ready-to-Use Low IgA Immunoglobulin Therapy for Primary Immunodeficiency

a day ago
5

Stalicla Secures CHF 2 Million Financing from Addex Therapeutics to Advance Precision Medicine for Autism and Neurodevelopmental Disorders

2 days ago
6

Vetter Breaks Ground on $285 Million Clinical Manufacturing Facility in Illinois

2 days ago
7

Portal Biotech Secures $35M Series A to Commercialize World's First Full-Length Single-Molecule Protein Sequencer

a day ago
8

ESTEVE Acquires Caprelsa Rights from Sanofi to Expand Rare Cancer Treatment Portfolio

2 days ago
9

China Approves ORPATHYS-TAGRISSO Combination for EGFR-Mutated Lung Cancer with MET Amplification

2 days ago
10

LogicFlo AI Secures $2.7M to Deploy AI Agents Across Life Sciences Operations

a day ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy