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Clinical Trial News

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

  • The Phase III ARANOTE trial demonstrated that NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS).
  • The trial showed a 46% statistically significant reduction in the risk of progression or death compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001).
  • NUBEQA plus ADT now demonstrates efficacy in mHSPC both with and without docetaxel, based on the ARANOTE and ARASENS trials, establishing it as a versatile treatment option.
  • The safety profile of NUBEQA in the ARANOTE trial was consistent with previous findings, with no new safety signals observed, supporting its use in mHSPC.

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

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

Aethlon Medical's Hemopurifier Trial Activated at Royal Adelaide Hospital for Solid Tumor Patients

  • Aethlon Medical has initiated a clinical trial at Royal Adelaide Hospital to evaluate the Hemopurifier's safety and feasibility in solid tumor patients resistant to anti-PD-1 antibodies.
  • The trial will assess the Hemopurifier's ability to remove extracellular vesicles (EVs) from the bloodstream, potentially improving response to therapies like pembrolizumab and nivolumab.
  • This dose-finding study will enroll approximately 18 patients, monitoring adverse events and changes in safety lab tests after Hemopurifier treatment, following initial PD-1 antibody therapy.
  • Aethlon plans to expand the trial with a second site in Australia and anticipates ethics committee approval for a clinical site in India.

Poseida Therapeutics' P-BCMA-ALLO1 Receives FDA RMAT Designation for Relapsed/Refractory Multiple Myeloma

• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Poseida Therapeutics' P-BCMA-ALLO1 for relapsed/refractory multiple myeloma. • The RMAT designation was based on encouraging early data from the ongoing Phase 1 study, highlighting P-BCMA-ALLO1's potential efficacy and safety. • P-BCMA-ALLO1 targets B-cell maturation antigen (BCMA) and has shown clinical responses in heavily pre-treated patients, including those with prior BCMA-targeted therapies. • Poseida plans to present new clinical data at the International Myeloma Society Annual Meeting and will collaborate with Roche to advance this allogeneic CAR-T therapy.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

InspireMD Submits FDA Premarket Approval Application for CGuard Prime Carotid Stent System

  • InspireMD has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system, aimed at preventing stroke.
  • The PMA is supported by positive data from the C-GUARDIANS clinical trial, which demonstrated a low major adverse event rate of 1.95% at one year.
  • The C-GUARDIANS trial enrolled 316 patients across U.S. and European sites, evaluating the safety and efficacy of CGuard for carotid artery stenosis.
  • If approved, InspireMD anticipates a U.S. commercial launch of the CGuard Prime system in the first half of 2025.

TransCon CNP Demonstrates Superior Growth in Achondroplasia Trial

  • TransCon CNP met its primary endpoint, showing a statistically significant improvement in annualized growth velocity (AGV) compared to placebo at Week 52 (p<0.0001).
  • Children aged 5-11 years treated with TransCon CNP showed a greater change from baseline AGV compared to placebo, with a statistically significant difference of 1.78 cm/year (p<0.0001).
  • The trial indicated that TransCon CNP was generally well-tolerated, with a low incidence of mild injection site reactions and a safety profile comparable to placebo.
  • Ascendis Pharma plans to submit regulatory applications to the FDA in Q1 2025 and to the EMA in Q3 2025, seeking approval for TransCon CNP as a treatment for achondroplasia.

Imfinzi Demonstrates Significant Survival Benefit in Muscle-Invasive Bladder Cancer

• The NIAGARA trial showed that adding Imfinzi (durvalumab) to neoadjuvant chemotherapy significantly improved event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC). • The Imfinzi regimen reduced the risk of death by 25% and improved EFS by 32%, with 82% of patients alive at 24 months compared to 75% in the control group. • The study's results, presented at ESMO, were described as practice-changing, with a manageable toxicity profile, potentially transforming the standard of care for MIBC patients. • AstraZeneca is considering filing the NIAGARA data with the FDA, while the agency previously raised concerns about peri-operative immunotherapy regimens in resectable cancers.

InspireMD Seeks FDA Approval for CGuard Prime Carotid Stent System After Positive Trial Results

• InspireMD has submitted a Premarket Approval application to the FDA for its CGuard Prime carotid stent system, designed to prevent stroke by treating carotid artery stenosis. • The application is based on the C-GUARDIANS clinical trial, which reported a low major adverse event rate of 1.95% at one year post-procedure. • InspireMD is preparing for a potential U.S. commercial launch of CGuard Prime in the first half of 2025, pending FDA approval, and is setting up commercial infrastructure. • The CGuard Prime system utilizes InspireMD's MicroNet technology and aims to become the industry standard for carotid stenting with superior acute and long-term outcomes.

Evaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Phase 2 Melanoma Trial

  • Evaxion Biotech's EVX-01, combined with pembrolizumab, demonstrates a 69% Overall Response Rate (ORR) in advanced melanoma patients.
  • The personalized vaccine, designed using Evaxion's AI-Immunology platform, induced a targeted immune response in 79% of patients.
  • The AI platform showed a strong predictive capability (p=0.00013) correlating with the observed immune response, suggesting robust technology.
  • Final results from the phase 2 trial are expected in the third quarter of 2025, with potential for significant advancement in melanoma treatment.

FDA Extends Review of Treosulfan NDA for AML and MDS Treatment

  • The FDA has extended the review period for the New Drug Application (NDA) of treosulfan by three months, setting a new PDUFA target action date of January 30, 2025.
  • The extension was prompted by the need for additional time to review supplemental analyses of previously submitted data related to the drug.
  • The NDA seeks approval for treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients with acute myeloid leukemia and myelodysplastic syndromes.
  • Medexus remains optimistic about the potential approval of treosulfan and anticipates a commercial launch in the first half of calendar year 2025.

FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in adults and adolescents (12+ years, >=40kg).
  • Ebglyss, a targeted IL-13 inhibitor, is indicated for patients whose atopic dermatitis is not adequately controlled by topical prescription therapies.
  • Clinical trials (ADvocate1, ADvocate2, ADhere) demonstrated that Ebglyss, as monotherapy or with topical corticosteroids, significantly improved skin clearance and itch relief.
  • Ebglyss offers a convenient once-monthly maintenance injection following an initial treatment phase, providing long-lasting symptom relief for eczema patients.

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