MedPath

Clinical Trial News

Scemblix Receives Positive CHMP Opinion for CML Treatment After TKI Failure

  • The CHMP has recommended Scemblix (asciminib) for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) in adults after two or more tyrosine kinase inhibitors (TKIs).
  • Phase III ASCEMBL trial data showed Scemblix nearly doubled the major molecular response rate compared to bosutinib (25.5% vs. 13.2%) at 24 weeks.
  • Discontinuation rates due to adverse reactions were more than three times lower with Scemblix compared to bosutinib (5.8% vs 21.1%) in the ASCEMBL trial.
  • Scemblix, a STAMP inhibitor targeting the ABL myristoyl pocket, offers a novel mechanism to combat TKI resistance and intolerance in CML patients.

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

NCT04971226Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/6/2021

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

NCT03106779CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/26/2017

Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors

NCT04795427CompletedPhase 2
Novartis Pharmaceuticals
Posted 12/6/2021

Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

NCT04666259CompletedPhase 3
Novartis Pharmaceuticals
Posted 5/25/2021

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

NCT02081378CompletedPhase 1
Novartis Pharmaceuticals
Posted 4/24/2014

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

NCT04925479RecruitingPhase 1
Novartis Pharmaceuticals
Posted 12/27/2021

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

NCT03578367CompletedPhase 2
Novartis Pharmaceuticals
Posted 11/22/2018

Asciminib Treatment Optimization in ≥ 3rd Line CML-CP

NCT04948333Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/13/2021

FDA Grants Accelerated Approval to Dabrafenib and Trametinib Combination for BRAF V600E-Mutated Solid Tumors

  • The FDA granted accelerated approval to Novartis' dabrafenib and trametinib combination for BRAF V600E-mutated solid tumors.
  • This approval targets adult and pediatric patients (≥6 years) with unresectable or metastatic tumors who progressed after prior treatment.
  • The therapy is indicated for patients lacking satisfactory alternative treatment options, addressing an unmet need in advanced solid tumors.
  • Novartis' Tafinlar and Mekinist demonstrated efficacy in a study, supporting the FDA's decision for accelerated approval.

FDA Approves Novartis' Tafinlar + Mekinist Combo for BRAF V600E-Mutated Solid Tumors

  • The FDA granted accelerated approval to Novartis' Tafinlar and Mekinist combination for advanced solid tumors harboring the BRAF V600E mutation after prior therapy and no alternative options.
  • This marks the first BRAF/MEK inhibitor approved for pediatric patients, expanding its use to individuals as young as six years old.
  • The approval was based on clinical trials demonstrating efficacy and safety, with overall response rates reaching up to 80% in some tumor types.
  • The expanded approval potentially covers over 20 different tumor types, including gliomas, biliary tract cancer, and gynecological and gastrointestinal cancers.

Study on Brentuximab Vedotin Combination Therapy for Relapsed/Refractory DLBCL Shows Promising Results

A recent study on the combination of Brentuximab Vedotin, lenalidomide, and rituximab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) has shown promising clinical activity, with a 70% overall response rate among patients. The study highlights the potential of this combination therapy for patients who have relapsed after or are ineligible for hematopoietic stem cell transplant or CAR-T therapy.

Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

NCT04404283Active, Not RecruitingPhase 3
Seagen, a wholly owned subsidiary of Pfizer
Posted 8/20/2020

Advances in the Clinical Development of Oncolytic Viruses

This article reviews the progress in clinical trials of oncolytic viruses (OVs) for cancer treatment, highlighting their safety, effectiveness, and the challenges faced in their development. OVs selectively infect and kill cancer cells without harming normal cells, showing promise in treating various tumors with mild adverse events.

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

NCT01869088Unknown StatusPhase 3
Sun Yat-sen University
Posted 1/1/2013

Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

NCT03790059Unknown StatusNot Applicable
Southwest Hospital, China
Posted 10/1/2016

Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites

NCT04771676CompletedPhase 2
Fudan University
Posted 3/5/2021

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

NCT03780049Unknown StatusPhase 3
Sun Yat-sen University
Posted 10/1/2018

Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

NCT05051696Active, Not RecruitingPhase 2
Liu Zi
Posted 9/26/2021

Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

NCT02579564Unknown StatusPhase 3
Xinqiao Hospital of Chongqing
Posted 10/1/2016

Valbiotis Announces Major Success in Phase II HEART Clinical Study for TOTUM-070

Valbiotis has reported significant success in its Phase II HEART clinical study, demonstrating that TOTUM-070, a patented plant-based active substance, effectively reduces LDL cholesterol and triglycerides, key cardiovascular risk factors, in individuals with mild to moderate hypercholesterolemia. The study, involving 120 volunteers, showed promising results after just three months of supplementation, with plans for commercialization by the first half of 2024.

Sling Therapeutics Launches with $35M Series A Financing to Develop Oral Small Molecule for Thyroid Eye Disease

Sling Therapeutics, Inc. has officially launched with a $35M Series A financing led by TPG's The Rise Fund, aiming to develop linsitinib, an oral small molecule for treating Thyroid Eye Disease (TED). The company has received FDA IND clearance and is preparing to initiate a Phase 2b clinical trial. Linsitinib, designed to inhibit the IGF-1R signaling pathway, offers a potential convenient oral treatment option for TED patients, aiming to reduce the treatment burden significantly.

Lead Pharma and Oxeltis Secure €800K Grant to Develop First-in-Class DLBCL Therapy

OncologyDrug Discovery
  • Lead Pharma and Oxeltis received an €800K EUREKA Eurostars grant to fund their three-year EPIGENEXT project developing a first-in-class small molecule therapy for diffuse large B-cell lymphoma.
  • DLBCL affects approximately 115,000 people worldwide annually, with 30-50% of patients experiencing relapse after standard R-CHOP treatment and poor long-term survival rates.
  • The collaboration aims to address the significant unmet medical need in DLBCL treatment, where current chemotherapy approaches cause debilitating side effects and fail to cure nearly half of patients.

Bayer's BlueRock Therapeutics Expands to Europe with New Berlin Site

Bayer AG announced the establishment of a new site for BlueRock Therapeutics in Berlin, Germany, to strengthen its cell therapy capabilities and accelerate the development of innovative treatments, including the ongoing BRT-DA01 clinical trial for Parkinson's disease.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.