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Clinical Trial News

FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis

  • The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for all forms of multiple sclerosis, including relapsing MS and primary progressive MS.
  • Ocrevus Zunovo offers a quicker 10-minute injection compared to the 2-4 hour intravenous infusion required for the original Ocrevus formulation.
  • Approval was based on the OCARINA II trial, demonstrating similar efficacy and safety profiles between subcutaneous and intravenous formulations of ocrelizumab.
  • This new formulation provides greater flexibility for healthcare providers and patients, potentially expanding treatment access to centers with limited IV infrastructure.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825CompletedPhase 3
Hoffmann-La Roche
Posted 5/3/2022

Sanofi Ships Beyfortus in US to Protect Infants Against RSV

  • Sanofi is shipping Beyfortus (nirsevimab-alip) doses in the US to help protect infants against RSV, aiming for equitable access through partnerships with government agencies.
  • The FDA approved a new Beyfortus filling line, expanding manufacturing capacity to meet anticipated demand for the 2024/2025 RSV season.
  • Beyfortus is the first and only long-acting monoclonal antibody approved for preventing RSV lower respiratory tract disease in newborns and infants.
  • RSV affects two out of three babies in their first year, leading to significant hospitalizations; Beyfortus offers fast-acting protection without immune system activation.

EASi-KIDNEY Trial Investigates Vicadrostat for Chronic Kidney Disease

  • The EASi-KIDNEY trial will assess vicadrostat's efficacy in slowing chronic kidney disease (CKD) progression when combined with existing treatments like empagliflozin.
  • The global trial aims to enroll approximately 11,000 participants across 15-20 countries, with initial recruitment in Oxford, UK.
  • Vicadrostat, developed by Boehringer Ingelheim, previously demonstrated promising results in a Phase II trial, reducing albuminuria, a marker of kidney benefit.
  • The trial will use Protas' new Cantata platform to streamline clinical trial management and aims to provide results by 2028/2029.

Velsera Technology Drives Advanced Cancer Diagnostics with FDA Approval of Illumina TruSight Oncology Comprehensive IVD

  • Velsera's tumor profiling technology is a key component of the knowledge base supporting the Illumina TruSight™ Oncology (TSO) Comprehensive IVD results report, enhancing personalized treatment.
  • The collaboration between Velsera and Illumina, started in 2018, aims to advance cancer diagnostics and improve the accessibility of targeted therapeutics nationwide.
  • Velsera's Knowledge Base classifies cancer mutations, enabling more personalized and effective treatment plans for patients, and facilitating NGS-based diagnostics adoption.
  • The FDA-approved TruSight™ Oncology Comprehensive test simplifies the identification of important cancer biomarkers, enhancing patient care through precise biomarker identification.

Kisqali Plus Endocrine Therapy Reduces Breast Cancer Recurrence by 28.5% in Phase 3 Trial

• Novartis' Kisqali, combined with endocrine therapy (ET), significantly reduced the risk of breast cancer recurrence by 28.5% in patients with stage II or III HR+/HER2- early breast cancer compared to ET alone. • The Phase 3 clinical trial data showed a sustained benefit beyond the three-year treatment period, offering a potential new treatment option for patients at risk of recurrence. • Novartis has submitted these results to the FDA and EMA, with an FDA decision on approval for this treatment anticipated this quarter, marking a potential advancement in breast cancer therapy.

CAR T-Cell Therapy Not Linked to Increased Risk of Second Cancers, Study Shows

  • A systematic review of over 5,500 lymphoma and myeloma patients found a 5.8% overall incidence of second primary malignancies (SPMs) after CAR T-cell therapy.
  • The risk of developing SPMs was similar between patients receiving CAR T-cell therapy and those undergoing standard of care treatments in randomized trials.
  • Hematologic malignancies were the most common SPM subtype, followed by solid tumors and nonmelanoma skin cancers, with T-cell malignancies being rare.
  • Factors like treatment setting, follow-up duration, and number of prior treatment lines were identified as potential risk factors for SPM development.

INmune Bio Announces $12 Million Offering to Advance Clinical Programs

  • INmune Bio is offering 2,341,260 shares of common stock along with warrants to raise approximately $12 million for clinical trials and corporate purposes.
  • The offering includes warrants exercisable beginning March 16, 2025, at $6.40 per share, expiring on March 16, 2030, subject to certain acceleration conditions.
  • Net proceeds will fund the Phase 2 Alzheimer's disease trial of XPro, initiate a Phase 2 trial for treatment-resistant depression, and continue INKmune programs.
  • Insider participation includes officers, directors, and employees purchasing approximately $800,000 of shares and warrants under similar terms.

Trishula Therapeutics' TTX-030 Shows Promise in Metastatic Pancreatic Cancer Phase 1 Trial

  • A Phase 1 trial of TTX-030 in first-line metastatic pancreatic cancer showed a median overall survival of 19.1 months in the efficacy-evaluable population.
  • Patients with high HLA-DQ expression (HLA-DQhigh) showed an even greater median overall survival of 21.9 months, suggesting a predictive biomarker.
  • The combination of TTX-030 with gemcitabine/nab-paclitaxel, with or without budigalimab, was well-tolerated, with adverse events consistent with chemotherapy.
  • A Phase 2 trial (ELTIVATE) is underway to further evaluate TTX-030 in metastatic pancreatic adenocarcinoma, focusing on progression-free survival in HLA-DQhigh patients.

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

NCT06119217Active, Not RecruitingPhase 2
Trishula Therapeutics, Inc.
Posted 3/25/2024

Pembrolizumab Plus Chemotherapy Improves Overall Survival in Early-Stage TNBC

  • Neoadjuvant pembrolizumab combined with chemotherapy, followed by adjuvant pembrolizumab, significantly improves overall survival in early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial demonstrated a 34% reduction in the risk of death with the pembrolizumab regimen compared to placebo in TNBC patients.
  • At a median follow-up of 75.1 months, the 5-year overall survival rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm.
  • Patients achieving pathological complete response (pCR) showed an overall survival benefit, irrespective of the treatment arm, highlighting the importance of early response.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Pfizer's Ponsegromab Shows Promise in Phase 2 Trial for Cancer Cachexia

  • Pfizer's ponsegromab demonstrated positive results in a Phase 2 trial for treating cancer cachexia, a wasting condition affecting millions worldwide.
  • The study showed that patients receiving ponsegromab experienced improvements in body weight, muscle mass, quality of life, and physical function.
  • Ponsegromab is slated to advance into late-stage trials next year, addressing a critical unmet need as there are currently no FDA-approved treatments for cachexia.
  • Cancer cachexia affects approximately 9 million people globally, highlighting the significance of this potential new therapeutic option.

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