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Clinical Trial News

Vorasidenib Approved in China's Boao Lecheng Pilot Zone for IDH-Mutant Glioma

  • Vorasidenib, a dual inhibitor of IDH1 and IDH2, has been approved for clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.
  • This approval allows Chinese patients with IDH-mutant diffuse glioma access to the drug before its official registration in China, aligning with global availability.
  • A real-world study is underway in Boao Lecheng to evaluate vorasidenib's safety and efficacy in Chinese patients, potentially accelerating research by 1-2 years.
  • Vorasidenib has already been approved in the US, Canada, Australia, Israel, Switzerland and UAE, marking a significant advancement in glioma treatment.

Enveda Biosciences Secures $130 Million to Advance AI-Powered Drug Discovery

• Enveda Biosciences has raised $130 million in a Series C funding round to advance its AI-driven drug discovery platform and clinical pipeline. • The funding will support clinical trials for multiple drug candidates, including ENV-294, an oral anti-inflammatory agent for atopic dermatitis. • Enveda's platform combines metabolomics data, machine learning, and high-throughput experiments to identify and develop novel therapeutics from nature. • The company's AI platform has characterized over 1 million natural compounds, creating a large dataset for drug discovery workflows.

Vorasidenib Approved for Clinical Use in China's Boao Lecheng Pilot Zone

  • Vorasidenib, a dual inhibitor of IDH1 and IDH2, has been approved for clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.
  • This approval marks the first use of Vorasidenib in Asia, preceding its availability in Europe, for treating Chinese patients with IDH-mutant diffuse glioma.
  • A real-world study is underway in Boao Lecheng to evaluate Vorasidenib's safety and efficacy in Chinese patients, potentially accelerating research by 1-2 years.
  • Vorasidenib has already been approved in the US, Canada, Australia, Israel, Switzerland and UAE, and is in preparation for official registration in China.

MEMBRANE Trial Demonstrates Benefits of MMA Embolization in Chronic Subdural Hematoma Treatment

  • The MEMBRANE trial demonstrated that middle meningeal artery (MMA) embolization with Trufill n-BCA, as an adjunct to standard care, significantly improves outcomes in chronic subdural hematoma (cSDH) patients.
  • The study met its primary effectiveness endpoint, showing a significantly lower failure rate in the embolization group compared to standard care alone, with an odds ratio of 0.529.
  • MMA embolization was statistically non-inferior to standard of care in achieving good functional outcomes at three months and almost achieved superiority based on mRS scores.
  • Subgroup analysis revealed the most significant treatment effect in surgical patients over 75, suggesting a substantial benefit in this vulnerable population.

Larotrectinib Shows High Efficacy in Pediatric Solid Tumors with NTRK Fusion

  • Larotrectinib demonstrates high effectiveness in pediatric patients with newly diagnosed infantile fibrosarcoma (IFS) and other solid tumors harboring NTRK gene fusions.
  • The study marks the first Children's Oncology Group (COG) trial to assess precision medicine in a front-line setting based on genetic biomarkers.
  • Results indicate larotrectinib could replace chemotherapy as a first-line treatment for NTRK fusion-positive tumors, reducing potential harm to developing organs.
  • The objective response rate within six cycles was 94% for IFS and 60% for other solid tumors, highlighting the drug's potential in pediatric cancer care.

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

NCT02637687Active, Not RecruitingPhase 1
Bayer
Posted 12/16/2015

A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

NCT02576431Active, Not RecruitingPhase 2
Bayer
Posted 9/30/2015

CRISPR Therapeutics Faces Slow Casgevy Launch Despite Regulatory Approvals

• CRISPR Therapeutics' stock has declined despite the FDA and EU approvals of Casgevy for sickle cell disease and transfusion-dependent beta thalassemia. • The initial launch of Casgevy, developed with Vertex Pharmaceuticals, has been slower than anticipated due to the complexity of the treatment and conditioning regimen. • CRISPR Therapeutics is advancing five other clinical-stage therapy candidates, including CTX112 for blood cancers, with promising early trial results. • Despite current losses, CRISPR Therapeutics maintains a strong cash position, providing a runway for Casgevy sales growth and pipeline development.

Zydus Healthcare to Conduct Phase III Trial for Glycopyrrolate/Indacaterol Inhaler

  • Zydus Healthcare will conduct a Phase III clinical trial for its fixed-dose combination of glycopyrrolate and indacaterol metered-dose inhalation, as recommended by the CDSCO panel.
  • The decision follows a review of Zydus Healthcare's bioequivalence study report and justification for a Phase III clinical trial waiver by the Subject Expert Committee (SEC).
  • The glycopyrrolate and indacaterol combination is intended for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
  • The Phase III clinical trial protocol must be submitted to CDSCO for further review by the committee before the trial can commence.

Combination Therapies Reshape Frontline HCC Treatment Landscape

  • Combination regimens, including STRIDE (single tremelimumab and regular-interval durvalumab), are transforming first-line HCC treatment, offering personalized options.
  • HIMALAYA trial's 5-year data showed STRIDE achieved a median OS of 16.43 months versus 13.77 months with sorafenib, marking the longest follow-up in unresectable HCC.
  • LEAP-012 study indicated that lenvatinib plus pembrolizumab and TACE improved median PFS to 14.6 months compared to 10.0 months with TACE alone.
  • Real-world data from the STELLAR trial supports the use of TKIs like lenvatinib for patients ineligible for or failing immunotherapy, showing manageable safety profiles.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

NCT03434379CompletedPhase 3
Hoffmann-La Roche
Posted 3/15/2018

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

NCT04039607Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 9/30/2019

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

NCT03778957Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/30/2018

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

NCT03713593CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2018

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

NCT01658878CompletedPhase 1
Bristol-Myers Squibb
Posted 10/30/2012

A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

NCT02519348Active, Not RecruitingPhase 2
MedImmune LLC
Posted 10/19/2015

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

NCT03755791Active, Not RecruitingPhase 3
Exelixis
Posted 6/10/2018

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

NCT04763408Completed
Eisai Inc.
Posted 4/9/2021

EZH2 Enzyme Drives Drug Resistance in Prostate Cancer via Novel Mechanism

  • Researchers identified that the enzyme EZH2 shifts its function in the absence of PKCλ/ι, promoting tumor growth in aggressive prostate cancer.
  • The altered EZH2 activity activates protein synthesis and growth factors like TGF-β, fostering resistance to androgen receptor inhibitors.
  • Targeting EZH2's alternative activities or the TGF-β pathway could re-sensitize cancer cells to androgen receptor inhibitors, offering new therapeutic strategies.
  • The study suggests combining androgen receptor inhibitors with EZH2 or TGF-β inhibitors, warranting precision medicine approaches for effective treatment.

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