Domestic PD-L1 antibody! Cornerstone pharmaceutical cs1001 showed strong efficacy in relapsed / refractory extranodal NK / T-cell lymphoma, with a complete remission rate of 33.3%

December 13, 2019 / BIOON / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical") recently published the latest experimental data of cs1001-201 research in the form of poster display at the annual meeting of the American Society of Hematology (ash) in 2019 This trial is a single arm, multicenter, phase II study to evaluate the efficacy of anti-PD-L1 antibody cs1001 in the treatment of recurrent or refractory extranodal natural killer cell / T-cell lymphoma (RR enktl) ENKTL belongs to a subtype of mature T and NK cell lymphoma Its distribution is regional, and the incidence rate in Asia is significantly higher than that in Europe and America Enktl has a high degree of malignancy, strong invasion and poor prognosis At present, after the failure of the combination chemotherapy with asparaginase, the patients lack of standard treatment methods, and the CR of the current targeted single drug treatment is less than 10% "Enktl accounts for 6% of all lymphoma types in China," said Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical We are facing the huge unmet treatment needs of these patients after the failure of the first-line program Cs1001-201 is the first clinical study of PD-L1 antibody for enktl patients in the world The latest research results show that cs1001 has good antitumor activity and survival benefit in RR enktl patients We will make every effort to promote the research of cs1001 in this indication and look forward to bringing new treatment options to patients as soon as possible " Dr Yang Jianxin, chief medical officer of cornerstone pharmaceutical, said: "CR is a key prognostic indicator for enktl treatment Compared with the patients who had partial remission before autotransplantation, the patients who had CR could significantly prolong the survival period and improve the prognosis According to the latest research data, the CR rate of cs1001 is as high as 33.3% and the remission rate is sustainable, while the objective remission rate is 43.3% and the 1-year overall survival rate is 72.4% Compared with the existing data of drug efficacy, it is a huge breakthrough and will probably create good conditions for subsequent hematopoietic stem cell transplantation to achieve cure " Cs1001-201 is a single arm, multicenter, phase II study to evaluate the efficacy of cs1001 in the treatment of recurrent or refractory extranodal natural killer cell / T-cell lymphoma (RR enktl) The main purpose was to investigate the objective response rate (ORR) assessed by the independent imaging assessment committee (irrc) The secondary objectives were to investigate the complete remission rate, partial remission rate, response time, duration of remission and progression free survival, total survival and safety of orr assessed by the investigator, irrc and the investigator Updated cs1001-201 results published by ash post: as of October 8, 2019, a total of 32 patients with RR enktl were enrolled in the study Among them, 24 patients (75.0%) were in stage IV, 9 patients (28.1%) had received second-line treatment, 7 patients (21.9%) had received third-line treatment or above All patients received cs1001120mg intravenously once every three weeks until the disease progressed or became intolerable The longest treatment time was 2 years The median follow-up time was 6.54 months (range 0.72-15.64 months) Of the 32 patients in the group, 13 (40.6%) were still receiving treatment and 19 (59.4%) were terminated The reasons for termination of treatment were progression of imaging diseases (12 cases), adverse events (4 cases) and deterioration of clinical symptoms without imaging evidence (3 cases) There is no preliminary data on the efficacy of treatment-related adverse events leading to death in patients: cs1001 shows good antitumor activity in RR enktl patients, and the patients obtain high Cr, long-term remission and survival benefit Of the 30 patients who achieved the efficacy evaluation, the orr evaluated by the researchers was 43.3% Among them, 10 patients (33.3%) achieved complete remission and were still in continuous remission Three patients (10.0%) achieved partial remission, and another one achieved partial remission after pseudoprogression The median duration of remission (DOR) has not been achieved, with a maximum of 10.9 + months The 1-year overall survival (OS) rate was 72.4% (95% CI: 52.0% - 85.2%) As of the data deadline, the irrc assessment has not been conducted Safety data: cs1001 was well tolerated in rr-enktl patients The median treatment duration was 12.6 weeks (range 3.0-69.1 weeks) During the treatment, 30 patients (93.8%) had adverse events 24 patients (75.0%) had treatment-related adverse events, 3 patients (9.4%) had treatment-related adverse events ≥ 3 levels Three patients (9.4%) had grade 5 adverse events, but none of them were related to cs1001 Seven patients (21.9%) had serious adverse events, including one case of grade 4 sick sinus syndrome and grade 1 myositis, which were assessed as cs1001 related by the researchers The two treatment-related serious adverse events were recovered Five patients (15.6%) had immune related adverse events, except for one patient with grade 3 rash, other immune related adverse events were all grade 1 4 cases (12.5%) were stopped due to adverse events during the treatment No patient died of cs1001 treatment-related adverse events Cs1001 cs1001 is a monoclonal antibody against PD-L1 developed by cornerstone pharmaceutical Cs1001 is produced by OMT transgenic animal platform authorized by ligand company of the United States, which can realize one-stop production of all human antibody As a full-length human anti-PD-L1 monoclonal antibody, cs1001 is a natural immunoglobulin-4 (IgG4) monoclonal antibody that is closest to human body Compared with similar drugs, cs1001 has a lower risk of immunogenicity and related toxicity in patients, which makes cs1001 have a potential unique advantage in safety Cs1001 has completed phase I clinical study dose escalation in China In the study of IA and IB, cs1001 showed good antitumor activity and tolerance in multiple indications Currently, cs1001 is undergoing a number of clinical trials, including a US bridging phase I trial In China, cs1001 is carrying out a multi arm IB phase test, two registered phase II tests and three phase III tests for multiple cancer species Source: cornerstone pharmaceutical