CD19 CAR-T Cell Therapy! Gilead Yescarta's first-line treatment of high-risk large cell lymphoma (LBCL) has a complete remission rate of up to 74%!

DECEMBER 09, 2020 // -- Kite Pharma, Gilead's cell therapy company, recently released the results of an interim analysis of the ZUMA-12 study of the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) at the 62nd annual meeting of the American Society of Hematology (ASH).
is a multi-center, one-arm, open-label Phase 2 study that is evaluating Yescarta's first-line treatment of adult patients with high-risk large B-cell lymphoma (LBCL).
data show that after receiving Yescarta single infusion therapy, after at least one month of follow-up, 85% of the 27 high-risk LBCL patients with assessable efficacy were in remission (total remission rate (ORR) and 74% were fully alleviated (full remission rate (CR) was 74%).
follow-up for 9.3 months, and 70 percent of patients who were assessed for remission were in continuous remission at the data cutoff.
9.5 months after the mid-level follow-up, the medium non-progression lifetime (PFS), the middle total lifetime (OS), and the medium mitigation duration (DOR) were not reached.
In all patients who received any dose of Yescarta and had at least one month of follow-up (n-32), 9% and 25% of patients had level 3 or higher cytokine release syndrome (CRS) and neurological events (NE).
level 5 CRS or NE has not occurred.
one case of level 5 adverse events caused by COVID-19.
Dr. Satva S. Neelapu, a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, said, "Despite the well-established standard treatment options for newly diagnosed large B-cell lymphoma (LBCL), patients with high-risk diseases are under-serviced under existing treatment options.
only half of these patients receive long-term remission through standard first-line treatment, there is an important need for treatments that can improve the prognosis of more patients.
results from the ZUMA-12 trial are very encouraging and confirm the potential of CAR-T cell therapy in early treatment of high-risk patients.
. Ken Takeshita, director of global clinical development at Kite, said, "Yescarta has provided four-year survival data in patients with third-line incurable LBCL, and we are excited about the results of early treatment in the ZUMA-12 study.
as the first positive result for CART-T's first-line treatment of LBCL, these data are a big step forward, and we are committed to bringing the therapeutic benefits of Yescarta to more high-risk LBCL patients.
"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) 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.
() Original origin: Yescarta® Show Positive Results as First-Line Treatment for Patients With High-Risk Large B-cell Lymphoma