U.S. FDA Approves Kite’s Tecartus® as the First and Only CAR-T Therapy for Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia-ALL (Image source: wikidoc.org)

October 13, 2021 /BioonBIOON/ -- Gilead's T-cell therapy company Kite recently announced that the U.S. Food and Drug Administration (FDA) ApprovedTecartus (brexucabtagene autoleucel, formerly known as KTE-X19) is a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed or refractory B-cell precursor acute lymphoblasticLeukemia(B-ALL) Adult patients (18 years of age and older). This approval marks the fourth indication for Kite's cell therapy, as well as the first indication for leukemia.

It is worth noting that,Tecartus is the first and only CAR T-cell therapy approved for the treatment of adult patients (≥18 years) with ALL.. This indication was approved through the priority review program. In 2016,FDATecartus has been granted Breakthrough Therapy Designation (BTD) for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

Given that approximately half of B-ALL patients relapse on currently available therapies, there is a substantial unmet medical need in this field. With current standard of care, the median overall survival (OS) is only approximately 8 months. Clinical data indicate that,A single infusion of Tecartus demonstrated durable responses, with 65% of patients achieving a complete response.

This approval was based on the results of the ZUMA-3 trial. This was a global, multicenter, single-arm, open-label Phase 1/2 study evaluating the efficacy and safety of Tecartus in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).The results showed that after a median actual follow-up of 12.3 months following a single infusion of Tecartus, 65% of evaluable patients (n=54) achieved complete response (CR) or complete response with incomplete hematologic recovery (CRi). The duration of CR exceeded 12 months in more than half of the patients. Among patients evaluable for efficacy, the median duration of response (DOR) was 13.6 months. In patients treated with the target dose of Tecartus (n=78), Grade ≥3 cytokine release syndrome (CRS) and neurological events occurred in 26% and 35% of patients, respectively, and were generally well-managed.

T-cell therapy is a highly promising treatment modality, and Kite is a leading enterprise in this field. In late August 2017, Gilead Sciences acquired Kite for $12 billion to enter this sector. In October 2017, Kite's first CAR-T cell therapy, Yescarta (axicabtagene ciloleucel, KTE-C19), received U.S.FDAapproved, becoming the world's first CAR-T cell therapy approved for the treatment of diffuse large B-cell lymphoma (DLBCL), and this therapy is also followingNovartisthe second CAR-T therapy approved for marketing after Kymriah (tisagenlecleucel-T, CTL019). In March 2021, Yescarta received U.S.FDAApproval of a new indication: Becomes the first CAR-T cell therapy to treat follicular lymphoma (FL).

Tecartus received US approval in July 2020FDAAccelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have previously received two or more systemic therapies, including a BTK inhibitor. Tecartus is the first CAR T-cell therapy approved for the treatment of R/R MCL, offering patients a transformative treatment option. Based on the pivotal ZUMA-2`Clinical Trial`Data show that a single infusion of Tecartus achieves an overall response rate (ORR) of up to 93% and a complete response rate (CR) of 67%. Notably, in the ZUMA-2 trial, Kite demonstrated a manufacturing success rate of up to 96% and an average manufacturing turnaround time of 15 days from leukapheresis to product delivery. Manufacturing speed is particularly critical for patients with advanced disease, whose conditions are severe and carry a risk of rapid deterioration.

Tecartus is an autologous, anti-CD19 CAR-T cell therapy that utilizes the XLP manufacturing process, including T-cell selection and lymphocyte enrichment. For certain B-cell malignancies with evidence of circulating lymphoblastsTumor，Lymphocyte enrichment is a necessary step. Currently, Tecartus is being developed for the treatment of mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), etc.

Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs. Survival rates for adult patients with relapsed or refractory ALL remain very low, with a median overall survival of approximately 8 months when treated with the most commonly used therapeutic agents. B-cell precursor ALL is the most common subtype, accounting for approximately 75% of ALL cases. Compared with other types of ALL, this subtype generally has poorer treatment outcomes. (Bioon.com)

Original Source:U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia