News

The chief medical officer of Eyevensys discussed the company’s work in developing sustained drug delivery systems.

The FDA has paused the clearance of new ofranergene obadenovec batches while it reviews chemistry, manufacturing, and controls at various source locations.

A comparative analysis of the ZUMA-5 and SCHOLAR-5 trials revealed improvements in outcomes over currently available therapies.

Previous research has suggested the efficacy of chimeric antigen receptor natural killer (CAR-NK) cells in hematological malignancies, and more recently, preclinical findings have raised the question of whether the type of treatment could be a viable, potentially more attractive option for solid tumors.

Bayer provided an update on trials currently underway for the treatment of PD by its subsidiaries.

New studies into chimeric antigen receptor (CAR)–engineered natural killer (NK) cells has shown promising results, explained Ulrike Köhl, PhD, MD, professor of immune oncology and director of the Institute for Clinical Immunology at the University of Leipzig in Germany.

Neurologic adverse effect associated with CAR T-cell therapies like ciltacabtagene autoleucel can be managed without long-term lasting effects, as long as they are caught and treated promptly in patients with relapsed/refractory multiple myeloma.

Long-term efficacy assessment of brexucabtagene autoleucel demonstrated high rates of MRD negativity and CR rates in pediatric and adolescent patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Bispecific T-cell engagers and chimeric antigen receptor T-cell therapies seem destined to move into earlier lines of therapy for multiple myeloma (MM), speakers at the European Hematology Association 2021 Virtual Congress said.

Axicabtagene ciloleucel and tisagenlecleucel have been used mostly to treat patients with diffuse large B-cell lymphoma in the outpatient setting.

Intensified induction therapy with daratumumab in addition to cyclophosphamide, bortezomib, lenalidomide, and dexamethasone and bortezomib-augmented autologous stem cell transplant yielded robust responses in patients with ultra¬ high–risk multiple myeloma or primary plasma cell leukemia

Treatment with the allogeneic CAR T-cell product ALLO-501A elicited encouraging signals of clinical activity when used with ALLO-647 lymphodepletion in patients with relapsed/refractory large B-cell lymphoma who did not previously receive autologous CAR T-cell therapy.

The incidence of grade ≥2 cytokine release syndrome was lower in patients with relapsed or refractory multiple myeloma who received anakinra prophylaxis with orvacabtagene autoleucel, a B-cell maturation antigen-targeted CAR T-cell therapy.

Cytovia is exploring several NK cell-based therapies, an emerging class of cell therapies with high potential for fewer side effects and greater anti-tumor activity.

RGX-314 may be a promising therapeutic option for exudative AMD.

The CAR T-cell therapy lisocabtagene maraleucel resulted in better efficacy versus standard of care with no new safety signals.

The therapy utilizes LogicBio’s GeneRide technology to insert a corrective copy of the target gene via synthetic AAV vectors.

C-CAR066 exhibited a favorable safety profile and promising efficacy in adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma who failed with prior CD19 CAR T-cell therapy.

With 5 chimeric antigen receptor (CAR) T-cell therapies approved by the FDA, and 299 agents in the pipeline, it’s no surprise that the virtual meeting of the European Hematology Association (EHA) will have a heavy presence of CAR T research being presented in sessions and posters.

Ciltacabtagene autoleucel, an investigational BCMA-directed CAR-T therapy, sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma.

Tisagenlecleucel led to high complete response rates that appear durable for patients with follicular lymphoma, prompting a regulatory submission later this year.

The FDA has lifted clinical holds placed on several BB305-based gene therapy programs from bluebird bio.

Dr. Munshi discusses the significance of the FDA approval of ide-cel in relapsed/refractory multiple myeloma, data from the KarMMa trial, which served as the basis for the approval, and next steps for CAR T-cell therapy in the field.

The combination of lifileucel and pembrolizumab was tolerable and led to responses for most patients with immune checkpoint inhibitor–naïve advanced melanoma.

The autologous CAR T-cell product CART-ddBCMA was found to elicit a 100% objective response rate in patients with relapsed/refractory multiple myeloma, with deep and durable responses noted in those with poor prognostic factors.

Results of a phase 1/2 trial show the feasibility of an approach targeting CLL1 in pediatric patients with relapsed or refractory acute myeloid leukemia.

Ciltacabtagene autoleucel elicited a response in nearly all patients with relapsed/refractory multiple myeloma previously treated with 1 to 3 prior treatments.

Results of the phase 2 SPEARHEAD-1 trial showed a high overall response rate with afamitresgene autoleucel in advanced synovial sarcoma or myxoid/round cell liposarcoma.