Keystone Pharmaceuticals anti-PD-L1 monoantigen is intended to be included in the breakthrough treatment varieties

Source: Pharmaceutical Mission China National Drug Administration Drug Review Center (CDE) the latest publicity, Keystone Pharmaceuticals Class 1 bio-new drug recombinant anti-PD-L1 human monoclonal antibody injection is intended to be included in the breakthrough treatment varieties, the proposed adaptation is: recurrence or refractory extraterrestrial natural killer cells / T cell lymphoma (R/R ENKTL).
According to public information, this recombinant anti-PD-L1 all-human monoclonal antibody injection, code-named CS1001 (Shugli monoantigen), was approved by the FDA in October 2020 as a breakthrough therapy for single-drug treatment of adult R/R ENKTL.
screenshot source: CDE official website from the cornerstone pharmaceutical industry public information can be found that CS1001 is the closest to the human body of natural G-type immunoglobulin 4 (IgG4) monoantigen.
it has a lower risk of immunogenicity and associated toxicity in patients, which gives it a potentially unique advantage.
in China, the listing application for the first-line treatment of advanced scaly and non-squamous non-small cell lung cancer patients with CS1001 combined chemotherapy was accepted by CDE in November 2020.
CS1001 obtained CDE to be included in the breakthrough treatment varieties of the adaptation is: recurrence or recurring non-curable natural killer cells / T cell lymphoma.
this is a malignant lymphoma, aggressive, poor prognosis.
pharmaceutical company noted in a press release that patients lack effective treatment after a standard solution based on mencholamidease failed.
because of the risk of disease, rapid progress, very short survival, one-year survival rate of less than 20%.
currently approved in China for targeted monotherapy complete remission (CR) rate of about 6%, patients after the failure of the first-line treatment program is facing significant unseeded treatment needs.
previously, CS1001 had achieved positive results in a study called CS1001-201, a single-arm, multi-center, phase 2 study evaluating CS1001 single-drug treatment for adult R/R ENKTL.
according to data released at the 2020 Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), CS1001 had an objective remission rate (ORR) of 44.7% in 38 ENKTL patients with assessable efficacy, a full remission rate of 31.6% and a median remission duration (mDoR) of 16.8 months.
43 patients who received the drug, the medium total survival period reached 19.7 months and the one-year total survival (OS) rate was 55.5%.
CS1001-201 is the world's first clinical study of PD-L1 antibodies in ENKTL patients, according to an earlier press release from Keystone Pharmaceuticals.
results of the study show that CS1001 has good anti-tumor activity and survival benefits in R/R ENKTL patients.
is a huge breakthrough compared to existing drug efficacy data and could create good conditions for subsequent hematopoietic stem cell transplants to be cured.
Currently, CS1001 is conducting a number of clinical trials, in addition to a U.S. Bridging Phase 1 study, in China, CS1001 is conducting a multi-arm Phase 1b clinical trial for multiple cancer species, a Phase 2 registered clinical trial for lymphoma, and four phase 3 registered clinical trials for Stage III, Phase IV.
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