Domestic PD-L1 antibody! Cornerstone pharmaceutical cs1001 showed good antitumor activity and safety in MSI-H / dmmr solid tumor patients

September 24, 2019 / biogu BIOON / - cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical") recently published in the form of oral report at the 22nd National Clinical Oncology Conference and 2019 CSCO academic annual conference the first time that the anti-PD-L1 antibody cs1001 in research is in a team named gemstone-101 stage IB high microsatellite instability / cell mismatch repair mechanism loss (MSI ‐ H / dmmr) Column The main purpose of this published MSI-H / dmmr cohort study is to preliminarily evaluate the antitumor efficacy of cs1001 as a second-line or above treatment in this kind of solid tumor patients, and further evaluate the safety and tolerance of cs1001 Microsatellite (MS) is a characteristic sequence composed of simple tandem repeats in DNA If the mechanism of cell mismatch repair is absent (dmmr), the microsatellite sequence may grow or be truncated This phenomenon is called microsatellite instability (MSI) MSI-H (MSI-High) means that the microsatellite is unstable, which indicates that there may be a large number of mutation related tumor antigens in the tumor cells, so as to have a good response to immunotherapy At present, the published results show that MSI-H / dmmr is the most common in endometrial cancer, gastric adenocarcinoma, small intestinal cancer and colorectal adenocarcinoma Professor Shen Lin, vice president of Cancer Hospital of Peking University and the reporter of this study, said: "the preliminary validity data of the test shows that cs1001 has shown good antitumor activity in MSI-H / dmmr solid tumor patients, and cs1001 also shows good safety and tolerance." Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said: "it's nice to see that our core candidate drug cs1001 has achieved good preliminary results in MSI-H / dmmr solid tumor cohort study At present, there is no PD-L1 inhibitor approved for the treatment of this kind of solid tumor in the world We expect cs1001 to show its potential in a wider range of tumor species in the future research, and become the fastest-growing immunotherapy drug in the field of MSI-H / dmmr solid tumor treatment in China " Dr Yang Jianxin, chief medical officer of cornerstone pharmaceutical, said: "based on the good response of MSI-H / dmmr solid tumor to immunotherapy, effective immunotherapy is expected to bring survival benefits to such patients In the published results, cs1001 has shown its therapeutic potential, with an objective response rate (ORR) of 38.1%, of which 28.6% has been confirmed This is an excellent result for patients who have been treated many times before At the same time, as a natural G-type immunoglobulin 4 (IgG4) monoclonal antibody closest to human body, we also expect cs1001 to show its unique advantages in safety in subsequent clinical trials " Gemstone 101 IB MSI ‐ H / dmmr cohort: the cohort study population was MSI ‐ H / dmmr patients with inoperable or metastatic solid tumors who failed to receive front-line treatment and did not have satisfactory alternative treatment There were 21 patients in this cohort, including 18 colorectal cancer, 2 pancreatic cancer and 1 small bowel cancer 13 patients had received at least 2 lines of treatment before admission During the study, patients received cs1001200 mg once every three weeks until the disease progressed or became intolerable Demographic and baseline characteristics: of the 21 patients in the group, 9 were still receiving treatment and 12 were terminated; the main reason for termination of treatment was disease progression (8 cases), patients decided to terminate treatment (2 cases), death caused by disease progression (1 case) and other (1 case); no patients terminated treatment due to adverse events Preliminary efficacy data: (1) cs1001 showed good antitumor activity in MSI-H / dmmr solid tumor patients 21 patients were included in the effectiveness analysis set, among which 8 patients (38.1%) met the partial remission (PR) defined by RECIST v1.1 standard, 28.6% of which were confirmed; (2) the disease control rate was 57.1% (12 / 21); (3) the duration of remission (DOR) ranged from 0.03 + to 8.6 + months, and the median duration of remission had not been achieved; safety data: Cs1001 has good security Among the 21 patients who received treatment, the median treatment duration was 137 (21-377) ）Days; during the treatment, 20 patients (95.9%) had adverse events, nearly 1 / 4 patients had adverse events ≥ 3 level; 18 patients (85.7%) had adverse events related to cs1001, only 1 patient (4.8%) had adverse event severity ≥ 3 level; 2 patients (9.5%) had SAE, but none was related to cs1001; 9 patients (42.9%) had adverse events The severity of immune related adverse events was 1-2; no patient stopped medication due to adverse events, and no patient died due to 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 phase ia study, cs1001 showed good antitumor activity and tolerance 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 Original source: 2019 csco| cstone announcements promising orr, anti tumor activity and safety data with its anti-PD-L1 anti-cs1001 in MSI-H