Clinical Trial News
FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65
- The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis.
- Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments.
- The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.
Ropeginterferon Alfa-2b Shows Promise in Polycythemia Vera Treatment
- Ropeginterferon alfa-2b demonstrates a high overall response rate of 90% in polycythemia vera (PV) patients, including complete and partial hematologic responses.
- The study found no dose-limiting toxicities with ropeginterferon alfa-2b, supporting its favorable safety profile and potential for long-term use.
- Treatment with ropeginterferon alfa-2b led to significant reductions in JAK2 V617F allelic burden, indicating molecular responses in PV patients.
- The research suggests that ropeginterferon alfa-2b could effectively normalize blood cell counts and prevent thromboembolic complications in PV patients.
Highlighted Clinical Trials:
AOP Orphan Pharmaceuticals AG
Posted 8/1/2010
Europe Emerges as Leading Hub for Precision Medicine Innovation and Implementation
- Europe's healthcare systems are rapidly adopting genomic medicine and personalized therapies, driven by collaboration among providers, payers, and pharmaceutical companies across the continent.
- The convergence of advanced diagnostics, genetic analytics, and companion diagnostics has created a mature ecosystem for precision medicine delivery in everyday clinical practice.
- European institutions' willingness to share platforms and data while maintaining security standards positions the continent to potentially surpass the US in precision medicine commercialization.
AstraZeneca Expands Immuno-Oncology Portfolio with Three Strategic Partnerships
- AstraZeneca secures rights to Inovio's INO-3112, a DNA vaccine targeting HPV-related cancers, in a deal worth up to $727.5 million, planning combination studies with durvalumab.
- MedImmune partners with Heptares on adenosine A2A receptor antagonist HTL-2071 for $510 million, aiming to enhance T-cell anti-cancer activity.
- A collaboration with Mirati Therapeutics will explore combining durvalumab with HDAC inhibitor mocetinostat in non-small cell lung cancer trials starting next year.
India Revamps Clinical Trial Regulations to Align with Global Standards
- India has significantly reformed its clinical trial regulations, extending SAE reporting timelines from 10 to 14 days to match international standards and streamlining the approval process.
- The regulatory framework now requires trials to be evaluated based on risk-benefit assessment, innovation value, and unmet medical needs in the country, ensuring greater transparency.
- New draft standards for accreditation of sites, investigators, and ethics committees have been introduced by CDSCO, aiming to enhance operational standards across clinical research.
Palbociclib Plus Letrozole Significantly Extends Progression-Free Survival in ER+ Breast Cancer
- Palbociclib, a CDK4/6 inhibitor, combined with letrozole, an aromatase inhibitor, significantly improved progression-free survival (PFS) in postmenopausal women with ER+/HER2- metastatic breast cancer.
- The PALOMA-1/TRIO-18 phase II trial demonstrated a median PFS of 20.2 months with the palbociclib-letrozole combination, compared to 10.2 months with letrozole alone.
- Palbociclib received accelerated FDA approval based on these results, pending confirmatory phase III trial outcomes, marking a significant advancement in targeted therapy for hormone receptor-positive breast cancer.
- Common adverse events associated with the combination therapy included neutropenia and leukopenia, manageable through dose modification and blood count monitoring.
Highlighted Clinical Trials:
Dana-Farber Cancer Institute
Posted 1/1/2014
Spanish Breast Cancer Research Group
Posted 3/13/2014
Pfizer
Posted 10/19/2012
Eli Lilly and Company
Posted 4/20/2015
University of Texas Southwestern Medical Center
Posted 1/24/2014
Pfizer
Posted 3/23/2015
Washington University School of Medicine
Posted 4/10/2013
Royal Marsden NHS Foundation Trust
Posted 3/25/2015
University of California, San Francisco
Posted 10/19/2015
German Breast Group
Posted 10/30/2013
Pancreatic Cancer Action Network and Perthera Launch "Know Your Tumor" Initiative for Precision Treatment
- The Pancreatic Cancer Action Network has partnered with Perthera to launch "Know Your Tumor" initiative, offering molecular profiling services to guide personalized treatment decisions for pancreatic cancer patients.
- The program aims to streamline molecular testing processes, providing comprehensive tumor analysis reports within one month of biopsy, while building a database of approximately 3000 patient molecular profiles over three years.
- With pancreatic cancer's dire 6% five-year survival rate, this initiative represents a significant step toward the goal of doubling survival rates by 2020 through personalized treatment approaches.
Serum Free Light Chain Levels Predict Need for Future PCI in STEMI Patients
- Combined free immunoglobulin light chain (cFLC) levels were evaluated in ST-elevation myocardial infarction (STEMI) patients, showing a peak on day 7 post-MI.
- cFLC levels in STEMI patients correlated with cystatin C and negatively correlated with CD14++CD16- monocytes, indicating associations with renal function and inflammation.
- Elevated cFLC concentrations were associated with an increased need for future percutaneous coronary intervention (PCI), suggesting a predictive value.
- The study highlights the potential of cFLC levels as a biomarker for risk stratification in STEMI patients regarding future interventional needs.
Novartis Revolutionizes Clinical Trial Recruitment Through Digital Innovation and Social Media
- Novartis has launched a dedicated Twitter channel @NovartisCancrUS reaching nearly 10,000 followers to promote cancer clinical trials and facilitate patient recruitment in the United States.
- The company has developed an interactive global clinical trials database with GPS functionality, allowing patients worldwide to locate and connect with nearby trial opportunities.
- Novartis's innovative Signature trial program enables personalized cancer trials across the US, matching patients' genetic alterations to relevant drugs while allowing them to receive treatment closer to home.
Highlighted Clinical Trials:
Novartis Pharmaceuticals
Posted 5/1/2014
PARP Inhibitors Show Promise in Epithelial Ovarian and Breast Cancers with BRCA1/2 Mutations
- PARP inhibitors have demonstrated efficacy in platinum-sensitive epithelial ovarian cancer, particularly in high-grade serous disease, and in breast cancer with BRCA1/2 mutations.
- Olaparib maintenance therapy significantly improved progression-free survival in relapsed high-grade serous ovarian cancer, especially in patients with BRCA1/2 mutations.
- Clinical trials are underway to evaluate PARP inhibitors like veliparib, rucaparib, and niraparib in various solid tumors, aiming to identify predictive biomarkers for patient selection.
- Research suggests PARP inhibitors' mechanism involves multiple aspects of PARP1 biology, including BER inhibition, PARP1 trapping, defective BRCA1 recruitment, and NHEJ activation.
Highlighted Clinical Trials:
AstraZeneca
Posted 12/16/2014
AstraZeneca
Posted 9/3/2013
AstraZeneca
Posted 3/27/2014
National Cancer Institute (NCI)
Posted 12/15/2014
AstraZeneca
Posted 8/26/2013
pharmaand GmbH
Posted 4/7/2014
Tesaro, Inc.
Posted 2/25/2014
AstraZeneca
Posted 4/22/2014
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Tesaro, Inc.
Posted 6/21/2013