CD19 CAR-T Cell Therapy! Gilead Yescarta Treatment Recurrence/Difficult Inert Non-Hodgkin's Lymphoma (iNHL): Total remission rate of 92%!

December 08, 2020 // -- Kite Pharma, a cell therapy company owned by Gilead, recently announced the results of a major analysis of the ZUMA-5 study of the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) at the 62nd annual meeting of the American Society of Hematology (ASH).
ZUMA-5 (NCT03105336) is a global, multi-center, single-arm, open-label Phase 2 study that includes adult patients with relapsed or refroffic (R/R) inert non-Hodgkin's lymphoma (iNHL) (age ≥18), including folytic lymphoma (FL) and marginal lymphoma (MZL) subtypes.
these patients have previously received at least two systemic treatments, including an anti-CD20 monoantigen in adane-based drugs.
study was designed to assess the effectiveness and safety of a single infusion of Yescarta in this patient group. data released at the
ASH Annual Meeting showed that after receiving Yescarta's single infusion treatment, the medium follow-up was 17.5 months: 92% of the 104 patients with assessable efficacy were in remission (ORR-92%) and 76% were fully relieved (CR-76%). :(1) In R/R FL patients (n-84), 94% of patients were in remission (ORR-94%), 80% were in complete remission (CR-80%), and 64% of patients were in continuous remission at 17.5 months of medium follow-up.
(2) in patients with R/R MCL (n-20), 85% of patients were in remission (ORR-85%), and 60% of patients were in complete remission (CR-60%).
(3) medium mitigation duration (DOR), progress-free lifetime (PFS), total lifetime (OS) were not reached.
in safety analysis (n-146), level ≥3 cytokine release syndrome (CRS) and neurological events (NE) occurred in 7% and 19% of patients, respectively.
FL patients ≥ the rate of level 3 NE (15%) was lower than that of MZL patients (41%), and the rates of CRS were comparable in both groups.
there were 3 cases of level 5 adverse events, including 1 case of multiple organ failure in CRS patients associated with Yescarta treatment, 1 case of aortic mezzanine unrelated to Yescarta treatment, and 1 case of infection with cytosis unrelated to Yescarta treatment.
Based on ZUMA-5 research data, the FDA has accepted a Supplemental Biologics Licensing Application (sBLA) from Yescarta and granted priority review for the treatment of patients with recurring or incurable (R/R) folytic lymphoma (FL) and marginal lymphoma (MZL) who have previously received two or more system therapies.
FDA has designated the SBLA's Prescription Drug User Charges Act (PDUFA) target date of March 5, 2021.
, the FDA has granted Yescarta a breakthrough drug (BTD) to treat these adaptations.
FL and MZL are 2 inert (slow-growing) non-Hodgkin's lymphoma (iNHL).
if approved, Yescarta would be the first CAR-T cell therapy to be approved for the treatment of relapses or recurring 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 a specific adaptive disorder: for relapses or difficulty with 2 or more system therapies in the past Treatment in adult patients with therapeutic LBCL includes diffuse large B-cell lymphoma (DLBCL), primary vertical large B-cell lymphoma (PMBCL), high-level B-cell lymphoma (HGBL), and DLBCL (i.e., transformed FL, TFL) derived from fable lymphoma (FL).
yescarta is not suitable for the treatment of primary central nervous system lymphoma.
in China, Yescarta (Equilien seine injections, codenun FKC876) was developed by Fosun Kate Biotech Co., Ltd. (FOSUN Kite), a joint venture between Shanghai Fosun Pharmaceutical 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 systems. Adult patients with relapsed or refractic large B-cell lymphoma after sexual therapy, including diffuse large B-cell lymphoma (DLBCL) non-special-fingered, primary vertical B-cell lymphoma (PMBCL), high-level B-cell lymphoma, and blistered lymphoma-transformed DLBCL.
Yikili Lunsai Injection (codenmost FKC876) is Fosun Kate's targeted CD19 in vitro 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 systemic treatment of second-line or above in China.
origin: Yescarta ® First CAR T-cell The torapy Solution High Response Rates and Long Clinical Benefit in a Pivotal Indolent Non-Hodgkin Lymphoma Study