ASH 2020 | ZUMA-19: maximizing safety of CAR T-cell therapy in LBCL
Sattva Neelapu, MD, University of Texas MD Anderson Cancer Center, Houston, TX, emphasizes the clinical need to increase the safety of CAR T-cell therapy with minimal impact on efficacy for patients with relapsed/refectory (R/R) large B cell lymphoma (LBCL). CAR T-cells produce granulocyte-macrophage colony-stimulating factor (GM-CSF), which activates inflammatory responses through cytokine production. Prof. Neelapu goes on to discuss the ongoing Phase I/II ZUMA-19 trial (NCT04314843) evaluating the humanized monoclonal antibody lenzilumab as prophylaxis to neutralizes GM-CSF, and prevent cytokine-related adverse events in patients with R/R LBCL that are undergoing axicabtagene ciloleucel (axi-cel) therapy. The first set of results from the ZUMA-19 trial are expected in 2021. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Transcript (edited for clarity)
The ZUMA-19 study is a multicenter pilot study to evaluate lenzilumab which is an anti GM-CSF monoclonal antibody in combination with axi-cel immunotherapy in relapsed or refracted non-Hodgkin lymphoma. The primary rationale to do the study is based on observation on prior studies using axi-cel where we found that GM-CSF production was highly associated with neurological toxicity in patients. Here patients receive lenzilumab as prophylaxis prior to axi-cel infusion on day zero, a single infusion to neutralize any GM-CSF that’s been produced and then they’re monitored for toxicities for both CRS as well as neurological toxicity...
The ZUMA-19 study is a multicenter pilot study to evaluate lenzilumab which is an anti GM-CSF monoclonal antibody in combination with axi-cel immunotherapy in relapsed or refracted non-Hodgkin lymphoma. The primary rationale to do the study is based on observation on prior studies using axi-cel where we found that GM-CSF production was highly associated with neurological toxicity in patients. Here patients receive lenzilumab as prophylaxis prior to axi-cel infusion on day zero, a single infusion to neutralize any GM-CSF that’s been produced and then they’re monitored for toxicities for both CRS as well as neurological toxicity. Currently, this trial is ongoing. It’s currently in dose escalation and first set of data are expected to be reported sometime in next year.
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Disclosures
SSN served as Advisory Board member or consultant for Kite, a Gilead Company, Merck, Bristol-Myers Squibb, Novartis, Celgene, Pfizer, Allogene Therapeutics, Cell Medica/Kuur, Incyte, Precision Biosciences, Legend Biotech, Adicet Bio, Calibr, and Unum Therapeutics; received research support from Kite, a Gilead Company, Bristol-Myers Squibb, Merck, Poseida, Cellectis, Celgene, Karus Therapeutics, Unum Therapeutics, Allogene Therapeutics, Precision Biosciences, and Acerta; received royalties from Takeda Pharmaceuticals; and has intellectual property related to cell therapy.
