The world's first CAR-T cell therapy for inert lymphoma (iNHL).

Pharma, a cell therapy company owned by Gilead, recently announced that it had submitted CD19 CAR-T cell therapy yescarta to the U.S. Food and Drug Administration (FDA). A supplementary biological product licensing application (sBLA) for the treatment of patients with recurring or refractive (R/R) folytic lymphoma (FL) and marginal lymphoma (MZL) who have previously received 2 or more systemic therapies.Previously, the FDA had granted Yescarta a breakthrough drug (BTD) for the treatment of these adaptations. FL and MZL are two inert (slow-growing) non-Hodgkin's lymphomas (indolent NHL, iNHL). If
, Yescarta will be the first CAR-T cell therapy approved for R/R iNHL.Yescarta, approved by the FDA in October 2017, is the first CAR-T cell therapy to treat adult patients with relapsed or refractic large B-cell lymphoma (LBLC), with specific adaptations: relapsed or refractive LB for 2 or more system therapies in the past Treatment in adult CL patients includes diffuse large B-cell lymphoma (DLBCL), primary vertical large B-cell lymphoma (PMBCL), high-level B-cell lymphoma (HGBL), and DLBCL (i.e. transformative FL, TFL) derived from fable lymphoma (FL). Yescarta is not suitable for the treatment of primary central nervous system lymphoma.
The sBLA submission is supported by key analytical data from the PHASE II ZUMA-5 study, which has been presented to an upcoming scientific conference. The results of the interim analysis from the study were published at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO). The ZUMA-5 study was conducted in adult patients with R/R iNHL who had previously received at least two therapies, and interim analysis data showed that 93 percent of patients were in remission and 80 percent were fully relieved (CR) after a single injection of Yescarta."iNHL patients often experience a disease that starts slowly but becomes more aggressive over time," said Dr. Ken Takeshita, Director of Global Clinical Development at Kite. The efficacy observed in the ZUMA-5 study may provide a potential treatment option for high-risk patients with certain types of iNHL. We look forward to working with the FDA to bring Yescarta to iNHL patients as soon as possible. ZUMA-5 (NCT03105336) is a single-arm, multi-center, open-label Phase II study that targets 160 adult (≥18 years old) R/R iNHL patients, including FL and MZL subtypes, who have previously received at least two systemic treatments, including an anti-CD20 monoantigen and alkylation drug. The purpose of the study was to assess the effectiveness and safety of a single infusion of Yescarta in this patient group. The main endpoint of the study was the Objective Mitigation Rate (ORR) assessed by the Independent Review Commission (IRC) based on the Lugano Classification (2014). Secondary endpoints include full remission rate (CR), mitigation duration (DOR), progress-free lifetime (PFS), total lifetime (OS), safety, CAR T cell and cytokine levels. The study is ongoing.The interim analysis showed that in patients with assessable efficacy (n-96), the ORR was 93 and CR was 80%. Subgroup analysis showed that in patients with R/R FL (n-80), ORR was 95% and CR was 81%, and 68% of patients were still in remission after at least nine months of follow-up. In patients with R/R MZL (n-16), the ORR was 81% and cr was 75% after at least one month of follow-up. In terms of secondary endpoints, the medium follow-up time for all patients was 15.3 months, the medium DOR was 20.8 months, the middle PFS was 23.5 months, and the mid OS had not yet been reached.In China, Yescarta (Equili Lunsai Injection, codenate FKC876) was developed by Fosun Kate Biotech Co., Ltd. (FOSUN Kite), a joint venture between Shanghai Fosun Pharmaceuticals Group and Kate Pharmaceuticals. In mid-March, Fosun Kate announced that the National Drug Administration's (NMPA) Drug Review Center (CDE) had included a priority review of new drug listing applications (NDAs) for the treatment of second-line or above systemic treatments with CAR-T cell therapy product Equililonsai Injections (NDA) Adult patients with post-recurrence or refroutable large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) non-special-fingered, primary vertical B-cell lymphoma (PMBCL), high-level B-cell lymphoma, and blistered lymphoma conversion of DLBCL.The Ikili Lunsai Injection (codenmost FKC876) is Fosun Kate's targeted CD19 self-contained CAR-T cell therapy product that introduced Yescarta (axicabtagene ciloleucel) technology from Kate Pharmaceuticals and is authorized to localize production in China.The product is Fosun Kate's first CAR-T cell therapy product to be commercialized in China, and the first CAR-T cell therapy product officially accepted by the State Drug Administration (NMPA). As a new cancer treatment, FKC876 can bring new hope and opportunity to patients with large B-cell lymphoma who have relapsed or are difficult to treat after receiving second-line or above systematic treatment in China. (Bio Valley Bioon.com)original source: Kite Submits Supplemental Biologics License application to U.S. Food and Drug Administration for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas