Phase II trial shows new CAR-T therapy is viable in acute lymphoblastic leukemia patients

In a new Phase II ‘ZUMA-3’ study from researchers at Kite, a Gilead Company (CA, USA), a novel chimeric antigen receptor (CAR) T-cell therapy known as Tecartus has been evaluated in patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), which is an aggressive form of blood cancer.

The results were recently published in the journal, The Lancet, and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting (4–8 June 2021; virtual).

Treatment options for patients with relapsed or refractory B-precursor ALL are limited, and there is an immense need for novel therapies. Tecartus can use the patient’s own T cells to attack cancer cells – providing a novel avenue of therapy for patients with this disease.

“Outcomes in adults with ALL are poor relative to what is observed in children, with less than half of people over 20 years of age expected to survive the illness. It is on this background that CAR T-cell therapy with brexucabtagene autoleucel was tested in adults with relapsed B-ALL in ZUMA-3,” explained Bijal Shah, ZUMA-3 investigator and medical oncologist (Moffitt Cancer Center, FL, USA).

“In this international, multicenter study, we observed a response rate of 71%. Importantly, the majority of these responses were associated with undetectable minimal residual disease.”

Additionally, 97% of the patients had deep molecular remission – meaning that leukemia cells could not be found in the bone marrow even with very sensitive lab tests. However, side effects such as anemia and pyrexia were reported in 49% and 36% of patients, respectively.

Based on these results, the US FDA has granted Priority Review designation for Tecartus. If approved, Tecartus will become the first and only CAR-T therapy approved for adults with relapsed or refractory ALL.

“The data presented at ASCO today validate the response rates seen in the Phase I portion of the ZUMA-3 study and the transformative potential of Tecartus in adult patients with ALL,” concluded Frank Neumann, Kite’s Global Head of Clinical Development. “We have already seen the impact of Tecartus for patients with relapsed or refractory mantle cell lymphoma, and these new data are a significant next step in our continued commitment in developing our therapies for patients with leukemias and lymphomas.”

Ref:https://www.regmednet.com/phase-ii-trial-shows-new-car-t-therapy-is-viable-in-acute-lymphoblastic-leukemia-patients/کپی لینک کوتاه