Management discusses the Company’s data on Tislelizumab and Zanubrutinib presented at the American Society of Hematology (ASH) Annual Meeting at an Investor Meeting being held in San Diego, CA on December 3 at 11 pm.
Monday, December 3, 2018
Amgen to host investor meeting
Investor Meeting to discuss the data presented at the American Society of Hematology (ASH) Annual Meeting will be held in San Diego, CA on December 3 at 11 pm
Bluebird Bio to hold an analyst and investor event
In conjunction with the American Society of Hematology (ASH) Annual Meeting, Management holds an Analyst and Investor Event in San Diego, CA on December 3 at 11:30 pm.
Seattle Genetics to hold an investor and analyst event
Management discusses the Phase 3 ECHELON-2 Trial, as well as other key data presented at the ASH Annual Meeting, at an Investor and Analyst Event being held in San Diego, CA on December 3 at 11:15 pm.
Celgene announces initial clinical data of JCARH125 in multiple myeloma
Celgene announced initial safety data from its ongoing proof-of-concept trial of JCARH125 in patients with relapsed/refractory multiple myeloma. JCARH125 is an investigational BCMA-targeting CAR T cell therapy being developed by Juno Therapeutics, a Celgene company. Results were presented by Sham Mailankody, MBBS, in an oral presentation at the 60th American Society of Hematology Annual Meeting. The data reported from the multicenter, phase 1/2 EVOLVE trial includes patients who have been treated with JCARH125 in the dose escalation study. The primary objectives of the phase 1 portion of the trial are safety and identification of a recommended phase 2 dose. The patients enrolled in the study had to have received at least three prior lines of multiple myeloma therapy, including an autologous stem cell transplant for transplant eligible patients, a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Dose escalation is currently ongoing. At data cut off, 44 patients have been infused with JCARH125 in three dose escalation cohorts. These patients were heavily pretreated, with a median of seven prior lines of therapies , and 77% had high-risk cytogenetics. Seventy-one percent of patients experienced grade 1 and 2 cytokine release syndrome with 9% of patients experiencing grade 3/4 CRS. In addition, 18% of patients experienced grade 1 and 2 neurological events with 7% of patients experiencing a grade 3/4 event. Other frequent grade 3/4 AEs included neutropenia in 86%, anemia in 50%, thrombocytopenia in 43% and infection in 14%. In this first report of JCARH125 data, the median follow up was only 11 weeks, yet among infused patients, the overall response rate was 82%. At the lowest dose level of 50×106 CAR T cells, the ORR was 79% and 43% of patients achieved stringent complete response or complete response.
https://thefly.com/landingPageNews.php?id=2831625
Allogene, Servier present data from UCART19 phase 1 study
Allogene Therapeutic and Servier announced results from an updated analysis of pooled clinical data from two ongoing Phase 1 studies of UCART19, the first allogeneic CAR T-cell therapy in clinical study, in pediatric and adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The analysis showed that 82% of patients who received a lymphodepletion regimen consisting of fludarabine, cyclophosphamide and an anti-CD52 mAb achieved a complete remission or complete remission with incomplete blood recovery. In the four patients who received fludarabine and cyclophosphamide only, there was minimal UCART19 expansion and no response. Overall, 67% or 14/21 of patients achieved a CR/CRi. These data suggest an anti-CD52 antibody is an important addition to the lymphodepletion regimen for allogeneic CAR T cell expansion. The most common adverse events were related to cytokine release syndrome and were generally manageable.
https://thefly.com/landingPageNews.php?id=2831633
Kite Pharma announces updated Zuma-3 data from KTE-X19 Phase 1/2 study
Kite, a Gilead Company, announced updated results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia. With a median follow-up of 15.1 months following a single infusion of KTE-X19, 69 percent of evaluable patients achieved complete tumor remission, defined as complete remission or CR with incomplete hematological recovery. The rate of undetectable minimal residual disease in patients who achieved complete tumor remission was 100%. Adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome and neurologic events in 23% and 39% of patients, respectively. The majority of these adverse events were resolved, with the exception of two patients who had ongoing neurological events at the time of death from other causes. Two patients died from adverse events deemed by the treating investigator to be related to KTE-X19.
https://thefly.com/landingPageNews.php?id=2831635
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