“Vitamin D deficiency (VDD) contributes to worse outcomes in elderly patients with diffuse large B-cell lymphoma (DLBCL) treated with rituximab, according to a study published online Aug. 18 in the Journal of Clinical Oncology.
“Jörg Thomas Bittenbring, MD, from Universitätsklinikum des Saarlandes in Germany, and colleagues examined the impact and mechanisms of VDD in patients with DLBCL. Chemoluminescent immunoassays were used to evaluate 359 pretreatment 25-hydroxyvitamin D3 serum levels from the RICOVER-60 study (6 Versus 8 Cycles of Biweekly CHOP-14 With or Without Rituximab) and 63 from the RICOVER-noRTh study (an amendment to the RICOVER-60 study).
“The researchers found that RICOVER-60 patients treated with rituximab with VDD (≤8 ng/mL) had 3-year event-free survival (EFS) of 59% and 3-year overall survival (OS) of 70%, while those with vitamin D levels >8 ng/mL treated with rituximab had EFS and OS of 79 and 82%, respectively. In multivariate analysis adjusting for International Prognostic Index risk factors, these differences remained significant, with hazard ratios of 2.1 (P = 0.008) for EFS and 1.9 (P = 0.040) for OS. In all 7 individuals with VDD, there were significant increases in rituximab-mediated cellular cytotoxicity (RMCC; P < 0.001) after substitution and normalization of their vitamin D levels.”
Editor’s note: This article is about results from an ongoing clinical trial—a research study with volunteer patients. The goal of the clinical trial is to test the effectiveness of a new non-Hodgkin lymphoma treatment called KTE-C19. So far, KTE-C19 has shown promising results, with eight out of 13 patients with advanced B-cell lymphoma experiencing complete remission and four experiencing partial remission.
“Kite Pharma (KITE) soared in after-hours trading on Monday after the company published successful data from its Phase 1-2a clinical trial of patients with aggressive non-Hodgkins lymphoma.
“Kite treated patients with its an anti-CD19 chimeric antigen receptor (CAR) T cell therapy called KTE-C19. Eight of 13 patients with Advanced B cell malignancies showed complete remissions, while four showed partial remissions. The total result was a 92% objective response rate.”
“Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the treatment of diffuse large B-cell lymphoma.
“Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. The orphan drug designation also would entitle Kite Pharma to a 7-year period of marketing exclusivity in the United States.”
Editor’s note: When a newly developed drug for a rare (“orphan”) disease seems particularly promising for patients, the FDA may choose to grant it “orphan drug designation.” The designation removes certain barriers that might otherwise keep a drug company from being able to successfully develop and profit from an orphan drug. A new treatment for diffuse large B-cell lymphoma has now been granted orphan drug designation.
“Scientists at the Department of Haematology and Oncology at the Nagoya Daini Red Cross Hospital in Japan have concluded that a drug called Zolinza (vorinostat) may improve outcomes for patients fighting indolent B-cell lymphomas like follicular lymphoma and mantle cell lymphoma.”