Oncology

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.

A single infusion of KTE-X19, a CAR T-cell therapy, demonstrated robust and durable responses in heavily pretreated patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The CAR T-cell therapy idecabtagene vicleucel continues to demonstrate improved survival among heavily pretreated patients with relapsed/refractory multiple myeloma.

An off-the-shelf natural killer cell therapy demonstrated high response rates and limited toxicity for patients with relapsed/refractory B-cell lymphoma.

Monalisa Ghosh, MD, discusses the role of off-the-shelf CAR T-cell therapy in patients with multiple myeloma.

Ross Macdonald, PhD, managing director and CEO of Cynata Therapeutics, discusses the biotech company's approach to overcoming reproducibility challenges with mesenchymal stem cells.

Maria A. Croyle, PhD, discusses the development of a novel film matrix that can safely and effectively store and transport AAV-based gene therapies.

Idecabtagene vicleucel elicited a median overall survival of 24.8 months with a 51% event-free rate at 24 months in patients with heavily pretreated, relapsed/refractory multiple myeloma.

An anticipated biologics license application for the tumor-infiltrating lymphocyte therapy lifileucel will be delayed until 2022, based on feedback from the FDA.

Maria A. Croyle, PhD, discusses the manufacturing challenges facing the gene therapy space and her inspiration for developing a novel preservation method for viral vector-based therapies.

A second treatment with CD19-directed CAR T-cell therapy plus ibrutinib (Imbruvica) following failed prior CD19-directed CAR T-cell therapy and salvage treatment with ibrutinib led to greater efficiency and anti-CD19 CAR T-cell amplification, but also higher grades of cytokine release syndrome and more serious hematologic toxicity in patients with refractory B-cell non-Hodgkin lymphoma.

Amitkumar Mehta, MD, discusses the safety profile of liso-cel and how it is advancing the relapsed/refractory large B-cell lymphoma treatment paradigm.

UCARTCS1A is the first allogeneic CAR T-cell product developed to target CS1 and SLAMF7, both of which are highly and consistently expressed in multiple myeloma.

The ongoing, phase 1/2 PrE0404 trial is evaluating the combination of ixazomib and ibrutinib in patients with relapsed/refractory mantle cell lymphoma with the goal of improving upon single-agent BTK inhibitor therapy in this patient population.

Based on findings from the SPEARHEAD-1 trial, Adaptimmune plans to submit a biologics license application to the FDA in 2022 for afamitresgene autoleucel to treat synovial sarcoma.

Dr. Abramson discusses the significance of the FDA approval of lisocabtagene maraleucel in refractory large B-cell lymphoma and provided insight into the efficacy and safety profiles of the CAR T-cell therapy as reported in the TRANSCEND NHL 001 trial.

A marketing authorization application has been submitted to the European Medicines Agency for the approval of the CAR T-cell therapy ciltacabtagene autoleucel in the treatment of patients with relapsed and/or refractory multiple myeloma.

The FDA has granted an orphan drug designation to the cell therapy ITIL-168 as a potential treatment for patients with stage IIB to IV melanoma.

Ajeet Gajra, MD, MBBS, FACP, talks about identifying and removing the barriers for offering CAR T-cell therapy at the community practice level.

Nina Shah, MD, discusses potential future directions with CAR T-cell therapy in multiple myeloma.

Nilanjan Ghosh MD, PhD, highlights progress made with CAR T-cell therapies in B-cell lymphoma and some ongoing trials generating interest in the field.

The FDA granted a Regenerative Medicine Advanced Therapy designation to the allogeneic chimeric antigen receptor T-cell therapy as a potential treatment for patients with relapsed/refractory multiple myeloma.

The FDA approval of brexucabtagene autoleucel established CAR T-cell therapy as a treatment option for patients with relapsed/refractory mantle cell lymphoma.

In a phase 1 study of the innate cell engager AFM13 pre-complexed with NK cells, all 4 patients with CD30-positive, relapsed/refractory Hodgkin lymphoma treated with the therapy achieved at least a partial response.

Saad Z. Usmani, MD, FACP, discusses the rapidly changing cellular therapy paradigm in relapsed/refractory multiple myeloma.

The FDA has granted an orphan drug designation to CYNK-001 as a potential treatment for adult patients with recurrent glioblastoma multiforme.

Lifileucel elicited objective responses, including complete responses, for a median duration that was not yet reached at 28.1 months for patients with advanced melanoma.

Nina Shah, MD, discusses the management of CAR T-cell therapy–related toxicities in multiple myeloma.

As more therapies continue to be approved, efforts will focus on toxicity prevention and mitigation strategies for associated unique and potentially life-threatening adverse reactions.

The FDA has approved idecabtagene vicleucel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.