24 Sep CAR T Therapy: What Recent Research Is Showing
CAR T therapy has been around for a while now, but the research has not slowed down. What started as a last-resort option for a narrow group of blood cancer patients has grown into something researchers are now testing in earlier treatment stages, in new cancer types, and in combination with other therapies. Here is a look at where things stand.
For years, CAR-T therapy was mostly reserved for patients who had already tried everything else and seen it fail. That is shifting. Recent phase 3 clinical trials — including ZUMA-7 and TRANSFORM — showed significant improvements in event-free survival when CAR T-cell therapy was used earlier as a second-line treatment rather than waiting until multiple prior therapies had failed. According to the NCI (National Cancer Institute), CAR T-cell therapies work by engineering a patient's own T-cells to recognize and attack cancer cells, and the FDA has now approved multiple CAR T products for several blood cancers — with clinical research continuing to expand both the indications and the timing of their use.
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Pixabay[/caption]
Prof. Dubinsky[/caption]
Marla Dubinsky, M.D.
Professor of Pediatrics and Medicine
Co-director of the Susan and Leonard Feinstein IBD Clinical Center
Chief of the Division of Pediatric Gastroenterology and Nutrition
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? How does MIRIKIZUMAB differ from other medications for UC?
Response: This is a phase 2 study to assess the PK (pharamcokinetics), safety and efficacy of mirikizumab in pediatric ulcerative colitis (UC).
Dr. Koh[/caption]
Andrew Y. Koh, M.D.
Associate Professor, Pediatrics and Microbiology
Dr. Leonard[/caption]
Dr. Cathy Leonard PhD
Department of Infection and Immunity
Luxembourg Institute of Health
Luxembourg
MedicalResearch.com: What is the background for this study?
Response: Cat allergy is a rapidly increasing phenomenon characterized by hypersensitivity and an excessive immune response to certain allergens associated with cats, among which the major allergen Fel d 1, a protein typically found in their saliva, on their skin and fur. Cat allergy manifestations can range from mild forms like itchy nose or sneezing to the development of severe symptoms such as rhinitis and asthma, with potentially fatal outcomes.
Only Allergen‐specific immunotherapy (AIT )can ensure an effective and longer lasting treatment in the more advanced cases. AIT typically consists in the subcutaneous injection of gradually increasing doses of the allergen of interest, until a critical quantity is reached that induces long-term immune tolerance. Nevertheless, there is still the need to improve cat AIT in terms of efficacy and safety. We hypothesized that immune tolerance to the allergen could be boosted by improving the adjuvanticity of AIT solutions, thereby optimizing the production of antibodies against Fel d 1, while minimizing inflammation.
Response: LENVIMA (lenvatinib), discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
LENVIMA is approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. The approved starting dose for LENVIMA is 18 mg daily. The objective of Study 218, a randomized, open-label, Phase 2 trial, was to assess whether the lower starting dose of LENVIMA (14 mg daily) in combination with everolimus (5 mg daily) would provide similar efficacy with an improved safety profile compared to the FDA-approved starting dose of LENVIMA (18 mg daily) plus everolimus (5 mg daily) in patients with advanced renal cell carcinoma (RCC) following prior treatment with an antiangiogenic therapy.
In the US, LENVIMA is also indicated for:
Dr. Soller[/caption]
Lianne Soller, PhD
Allergy Research Manager
BC Children’s Hospital Allergy Clinic
Vancouver, BC, Canada
MedicalResearch.com: What is the background for this study?
Response: Peanut oral immunotherapy (also known as OIT) has been studied for many years in clinical trials and has been found to be safe and effective in preschoolers. However, we know that clinical trials do not always reflect what happens in the real world.
We wanted to see study whether peanut OIT would work as well in the real world. This is a follow up of our preschool peanut OIT safety study published in April 2019 which noted only 0.4% severe reactions and 4% epinephrine use during build-up.