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Bristol-Myers Squibb has submitted a biologics license application to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.

The submission to the FDA for the investigational CAR T-cell therapy is based on data from the phase II ZUMA-II trial for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.

The drug candidate tipifarnib (Zarnestra) is being clinically studied for the treatment of patients with HRAS-mutant head and neck squamous cell carcinoma after progression on platinum therapy. 

The associate professor at The Ohio State University Comprehensive Cancer Center discussed the implications of her analysis of the CAR T-cell therapy tisagenlecleucel for patients with diffuse large B-cell lymphoma at the ASH Annual Meeting & Exposition.

Chimeric antigen receptor (CAR) T cells are lymphocytes genetically engineered to recognize and bind to specific proteins on cancer cells. Studies are currently underway for applications in other fields.

A biologics license application has been submitted to the FDA for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

The ZUMA-II trial suggested that patients with relapsed/refractory mantle cell lymphoma resistant to prior therapies may benefit from the autologous anti-CD19 CAR T-cell therapy.

Mazyar Shadman, MD, MPH, discussed the study he and colleagues are conducting to evaluate CAR T-cell therapy in high-risk patients with chronic lymphocytic leukemia.

The CAR T cell therapy bb21217 demonstrated high very good partial response or better rates in patients with heavily pretreated relapsed/refractory multiple myeloma.

Blinatumomab (Blincyto) as post-reinduction consolidation therapy before hematopoietic stem cell transplantation improved disease-free survival and overall survival by approximately 20% compared with intensive chemotherapy in pediatric and adolescent and young adult patients with high- or intermediate-risk of first relapse of B-cell acute lymphoblastic leukemia.

During the annual ASH meeting, investigators present phase 1 data from a new dose-climbing trial.

Treatment with the anti-CD19 CAR T-cell therapy KTE-X19 elicited a complete remission rate of 67% and an objective response rate of 93% for patients with relapsed/refractory mantle cell lymphoma.

Vecabrutinib, a reversible, noncovalent Bruton’s tyrosine kinase inhibitor, exhibited evidence of clinical activity in adults with B-cell malignancies without producing any grade ≥3 treatment-related adverse events.

The CD19-directed CAR T-cell therapy lisocabtagene maraleucel showed promising clinical activity and manageable toxicity in heavily pretreated patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma, all of whom had progressed on ibrutinib.

The French biotech Servier has an agreement with Allogene Therapeutics, through Pfizer, to market its allogenic chimeric antigen receptor (CAR) T-cell product in the United States if it receives FDA approval.

Steroid use while cytokine release syndrome and neurologic toxicities are at grade 1, instead of waiting until grade 3, reduces the rate of CAR T-cell treatment–related CRS and neurologic events.

In patients with relapsed mantle cell lymphoma, treatment with ibrutinib might mitigate a historical trend toward decreased progression-free survival with succeeding lines of therapy.

CD19-directed CAR T-cell therapy induced a high rate of rapid and durable complete responses in patients with aggressive relapsed/refractory large B-cell lymphoma.

Results from Avalere Health show that once Medicare patients get through the experience and expense of CAR T-cell therapy, they do well and costs drop significantly.

The CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) induced a median overall survival of 25.8 months for patients with refractory large B-cell lymphoma.

The BCMA-directed CAR T-cell therapy JNJ-4528 achieved a 100% overall response rate with early and deep responses in 29 patients with heavily pretreated relapsed/refractory myeloma.

Mosunetuzumab, a novel bispecific antibody, generated durable responses in patients with highly refractory non-Hodgkin lymphomas, including complete remissions in 22.2% of those who had previously received chimeric antigen receptor T-cell therapy.

Chimeric antigen receptor T-cell therapy targeting both BCMA and CD38 induced an objective response in >90% of patients with multiple myeloma who had been treated with at least 3 prior therapies and whose disease had spread outside of the bone marrow.

Successors to the first generation of chimeric antigen receptor (CAR) T-cell treatments will attack multiple targets and address the complexity of the manufacturing process by bringing uniformity to the creation of therapies, presenters said at the 61st American Society of Hematology Annual Meeting and Exposition in Orlando, Florida.

An investigational new drug application for the therapy, which is labeled FT596, was approved in September 2019 and human trials are scheduled to begin in the first quarter of 2020.

A recent study from Penn Medicine presented at ASH 2019 has found mosunetuzumab could be an effective treatment for B-cell non-Hodgkin lymphoma refractory to CAR T therapy.

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was associated with a 73.4% overall response rate in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial.

The CAR T-cell therapy axicabtagene ciloleucel induced a median overall survival of 25.8 months for patients with refractory large B-cell lymphoma.