The clinical study of TheR/R ENKTL of Therapy R/R ENKTL of Keystone Pharmaceuticals was reviewed by the FDA's experimental new drug.

Introduction: The world's first registered clinical study of anti-PD-L1 for recurring or refroutable natural killer cells/T-cell lymphoma (R/R ENKTL).
, 2020 /AAP/ -- China Suzhou-Keystone Pharmaceuticals (Suzhou) Co., Ltd. (hereinafter referred to as "Keystone Pharmaceuticals" or "Company", Hong Kong Stock Exchange Code: 2616) today announced its PD-L1 antibody Shugli monoanti (CS1001) An experimental new drug (IND) application for single-drug treatment of recurring or resuscable endocystrative natural killer cells/T-cell lymphoma (R/R ENKTL) has been reviewed by the U.S. Food and Drug Administration (FDA) and has obtained a letter of approval (SMP letter) to conduct the study.
Shugli monoanti is an all-human full-length anti-PD-L1 monoclonal antibody developed by Keystone Pharmaceuticals.
the immunogenicity of Shugli's monoantigens and the risk of associated toxicity in patients was lower than that of similar drugs.
CS1001-201 is a single-arm, multi-center, critical Phase II study of CS1001 single-drug treatment R/R ENKTL.
this IND application for review means that the CS1001-201 study being conducted in China will be extended to the United States.
ENKTL belongs to a subtype of mature T and NK cell lymphoma, and its distribution is regional in character, and the incidence rate in Asia is significantly higher than that in Europe and the United States.
, ENKTL accounts for about 6% of all lymphomas.
R/R ENKTL is highly malignant and invasive, with poor prognosmation.
patients with R/R ENKTL lack effective rescue treatment and do not respond well to traditional treatments after the failure of standard programmes based on mencholamidease.
clinicians are often helpless for such patients because of the risk of disease, rapid progress, very short survival, one-year survival rate of less than 20%.
the total remission rate (CR) of targeted single-drug therapy currently approved in China is about 6%.
are facing huge unseeded treatment needs after the failure of first-line treatment options, Shugli monoantigen is expected to offer new treatment options for these patients.
Jianxin Yang, Chief Medical Officer, Keystone Pharmaceuticals, said: "CR is a key prognossion indicator for ENKTL treatment.
previously reported CS1001-201 study data show that The CR rate of Shugli monoantigen is as high as 33.3% and the mitigation is sustainable, while the objective mitigation rate is 43.3% and the total one-year survival rate is 72.4%.
drug efficacy data is a huge breakthrough compared to the current drug, and will likely create good conditions for subsequent hematopoietic stem cell transplants to be cured.
we will continue to press ahead with this research and work closely with the FDA and the National Drug Administration of China (NMPA) to bring Shugli monoantigen to R/R ENKTL patients worldwide as soon as possible.
(Complete) CS1001-201 Study Overview CS1001-201 Study is a single-arm, multi-center, Phase II study evaluating the recurrence or refractic endocyst natural killer cell/T-cell lymphoma (R/R ENKTL) of Shuglidano single-drug therapy (ORRR).
results of the updated CS1001-201 study published in the American Society of Hematology (ASH) in 2019 show that as of October 8, 2019, a total of 32 R/R ENKTL patients were included in the study.
all patients receive Shugli monoantigen 1200 mg intravenous infusion every three weeks until the disease progresses or is inlerable.
follow-up time was 6.54 months (range 0.72-15.64 months).
preliminary effectiveness data Shugli monoantigen showed significant anti-tumor activity in patients with R/R ENKTL, with higher CR rates, lasting remission and survival benefits: of the 30 patients who achieved the efficacy assessment, the ORR assessed by the researchers was 43.3%10 In one case (33.3%) patients achieved complete remission and 3 patients (10.0%) who were still in continuous remission reached partial remission, and 1 patient who reached partial remission medium remission duration (DoR) after false progression did not reach a maximum of 10.9 plus 1 year total survival (OS) rate of 72.4% (95% CI: 52.0%-85.2%) safety data Shugli monoanti in R/R ENKTL patients with good safety and tolerance during treatment, In 30 cases (93.8%) patients had adverse events, 24 patients (75.0%) had treatment-related adverse events, of which 3 cases (9.4%) had treatment-related adverse events (9.4%) Patients had level 5 adverse events, but all of them had immune-related adverse events in 5 cases (15.6%) unrelated to Shugli monoantigen, except for 1 patient with level 3 rash, all other immuno-related adverse events were level 1 4 cases (12.5) %) Patients stopped due to adverse events during treatment no patients died due to adverse events related to Shugli monoantitherapy about Shugli monoanti (CS1001) Shugli monoanti is developed by Keystone Pharmaceuticals in the study of anti-PD-L1 monoclonal antibodies.
OmniRat® genetically modified animal platform, which is licensed by American company Liand, enables one-stop production of all-human antibodies.
as an all-human full-length anti-PD-L1 monoclonal antibody, Shugli monoantigen is a natural G-type immunoglobulin 4 (IgG4) monoantigen closest to the human body.
compared to similar drugs, Shugli monoantigen has a lower risk of immunogenicity and associated toxicity in patients, which gives Shugli monoantigen a unique advantage in terms of safety.
Shugli monoanti has completed a phase I clinical study dose climb in China.
in phase IA and IB studies, CS1001 showed good anti-tumor activity and tolerance in several adaptation certificates.
At present, Shugli monoantigen is conducting a number of clinical studies, in addition to a U.S. bridging Phase I study, in China, Shugli monoantigen is conducting a multi-arm IB phase study for multiple cancer species, two registered Phase II studies and four phase III registered clinical studies of stage III non-small cell lung cancer, stomach cancer and esophageal cancer, respectively.
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