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FDA Approves Ocrevus ZUNOVO: First Subcutaneous Injection for Multiple Sclerosis

  • The FDA has approved Ocrevus ZUNOVO as the first and only twice-yearly, 10-minute subcutaneous injection for relapsing and primary progressive multiple sclerosis.
  • Ocrevus ZUNOVO offers an alternative administration method, potentially expanding treatment access to centers with IV constraints or limited infrastructure.
  • Backed by a decade of safety and efficacy data from Ocrevus IV, the new formulation demonstrated consistent suppression of relapse activity and MRI lesions in trials.
  • The approval provides multiple sclerosis patients with more flexible treatment options tailored to individual needs, enhancing convenience and accessibility.

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

Daiichi Sankyo's DS-9606 Shows Promise in Phase I Trial for Advanced Solid Tumors

  • Daiichi Sankyo's DS-9606, an antibody-drug conjugate (ADC) targeting Claudin-6 (CLDN6), demonstrates promising clinical activity in patients with advanced solid tumors.
  • The Phase I trial assessed DS-9606's safety, tolerability, and efficacy, with preliminary results showing confirmed objective responses in heavily pretreated patients.
  • No dose-limiting toxicities were observed, and the most common treatment-emergent adverse events were nausea, fatigue, and anemia, with manageable Grade 3 or higher events.
  • Further evaluation in dose expansion cohorts is planned to determine the maximum tolerated dose and recommended dose for expansion across various CLDN6-expressing tumor types.

Signatera MRD Test Demonstrates Clinical Utility in Colorectal and Breast Cancer Studies

• Natera's Signatera MRD test shows promise in predicting overall survival in colorectal cancer (CRC) patients, potentially changing post-surgical management. • In CRC, Signatera-positive patients after liver metastasis resection benefited from adjuvant chemotherapy, while Signatera-negative patients did not show significant benefit. • The BELLINI trial indicates that ctDNA analysis with Signatera can identify clinical responders to immune checkpoint inhibitors in triple-negative breast cancer (TNBC). • These findings, from over 85 peer-reviewed publications, highlight Signatera's role in optimizing treatment decisions across multiple cancer types.

FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for Atopic Dermatitis Treatment

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis (eczema) in patients 12 years and older.
  • Ebglyss, a targeted IL-13 inhibitor, is administered as a monthly injection after an initial treatment phase to reduce eczema inflammation.
  • Clinical trials demonstrated that Ebglyss led to clear or almost clear skin in 38% of patients at 16 weeks, with sustained results in a majority at one year.
  • Lilly plans to launch Ebglyss in the U.S. soon, offering patient support programs to ensure access, and the drug has already been approved in the EU and Japan.

Daiichi Sankyo's DS-9606 Shows Promise in Phase I Solid Tumor Trial

  • Daiichi Sankyo's DS-9606, an antibody-drug conjugate (ADC) targeting Claudin-6 (CLDN6), demonstrates encouraging initial clinical activity in advanced solid tumors.
  • The Phase I trial assessed DS-9606's safety and tolerability across various doses, with no dose-limiting toxicities reported and manageable adverse events.
  • Preliminary efficacy results revealed confirmed objective responses in heavily pretreated patients, particularly in germ cell, gastric/esophageal, and non-small cell lung cancers.
  • The ongoing trial will determine the maximum tolerated dose and recommended dose for expansion, further evaluating DS-9606 in CLDN6-expressing advanced solid tumors.

Nivolumab and Ipilimumab Combo Shows Long-Term Survival Benefit in Advanced Melanoma

  • A decade-long study reveals that the combination of nivolumab and ipilimumab significantly extends survival in patients with advanced melanoma, offering a potential long-term solution.
  • The trial demonstrated that patients who were progression-free after three years had a high likelihood of remaining alive and disease-free at the 10-year mark.
  • The immunotherapy regimen did not show any increase in long-term adverse effects, confirming its safety profile over the extended study period.
  • Researchers suggest that these findings can shift patient expectations towards hope and optimism, potentially reducing the need for frequent oncologist visits.

Kisqali Demonstrates Sustained Benefit in Early Breast Cancer

• Updated analysis of the NATALEE trial shows Kisqali plus endocrine therapy reduces recurrence risk by 28.5% in stage II and III HR+/HER2- early breast cancer. • The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including node-negative disease. • Secondary endpoints, including distant disease-free survival, also showed consistent results, with a trend for improved overall survival. • The safety profile of Kisqali remains consistent with previous reports, showing a well-tolerated profile with generally low-grade adverse events.

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

ARANOTE Trial: Nubeqa Plus ADT Significantly Improves Outcomes in mHSPC

  • The Phase III ARANOTE trial demonstrated that darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in mHSPC patients.
  • Nubeqa reduced the risk of radiographic progression or death by 58% compared to placebo plus ADT, showing a clinically meaningful benefit.
  • The safety profile of Nubeqa plus ADT was comparable to that of placebo plus ADT, with similar rates of adverse events.
  • These findings support Nubeqa as a potential new treatment option for metastatic hormone-sensitive prostate cancer, addressing a critical unmet need.

NUBEQA® (darolutamide) Plus ADT Significantly Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

  • The Phase III ARANOTE trial demonstrated that NUBEQA plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in mHSPC patients.
  • NUBEQA plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001).
  • The safety profile of NUBEQA in the ARANOTE trial was consistent with previous studies, with similar rates of serious adverse events between treatment arms.

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

TREMFYA® (guselkumab) Approved by FDA for Ulcerative Colitis Treatment

  • The FDA has approved TREMFYA® (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC).
  • TREMFYA® is the first fully-human, dual-acting monoclonal antibody targeting both IL-23 and the CD64 receptor for UC treatment.
  • Clinical trials showed significant improvement in UC symptoms and endoscopic appearance of the intestinal lining with TREMFYA®.
  • This approval expands TREMFYA®'s indications, building on its use for plaque psoriasis and psoriatic arthritis.

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