Domestic PD-L1 antibody! The total remission rate of cs1001 combined with chemotherapy for advanced esophageal squamous cell carcinoma (ESCC) was 77.8%

September 20, 2019 / Biovalley BIOON / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical") recently announced the data of ESCC cohort of anti-PD-1 antibody drug cs1001 IB clinical research at the 22nd National Clinical Oncology Conference and 2019 CSCO academic annual meeting The published results are from an IA / IB phase, open label, multi dose, dose escalation, and dose expansion study to assess the safety, tolerability, pharmacokinetics, and antitumor efficacy of cs1001 in patients with advanced solid tumors or lymphoma in China The main purpose of the ESCC study cohort was to evaluate the preliminary antitumor efficacy of cs1001 as a first-line therapy combined with cisplatin + 5-fluorouracil (CF) chemotherapy, and to evaluate the safety and tolerance of cs1001 combined with CF chemotherapy Professor Li Jin, chairman of CSCO and director of Oncology Department of Shanghai Oriental Hospital, Tongji University, who reported the results, said: "the results of this study show that cs1001 combined with CF chemotherapy, as the first-line treatment of advanced ESCC, has good antitumor activity and long-lasting effect, with an objective remission rate of 77.8% The overall safety and tolerance are good." Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said: "cs1001 is a new immunooncology candidate drug specially developed to treat some of the most common malignant tumors in China ESCC is one of the most popular malignant tumors in China Data shows that more than 50% of the new cases and related deaths of esophageal cancer in the world occur in China, and more than 90% of them are esophageal cancer In the face of this huge challenge, we are very satisfied with the preliminary results of cs1001 in the ESCC cohort, because these findings show the great therapeutic potential of cs1001 We hope cs1001 can achieve better results in future research and soon become a new treatment option for ESCC patients " Overview of ESCC cohort of gemstone-101 IB phase 1L study: ESCC cohort includes advanced ESCC patients who have not been treated for locally advanced or metastatic esophageal cancer in the past In the study, patients received 1200 mg dose of cs1001 every three weeks until their condition worsened or intolerable, and CF chemotherapy every three weeks for up to six treatment cycles Demographic and baseline characteristics as of July 1, 2019, a total of 23 patients were enrolled in the ESCC cohort for treatment, 17 of whom were still in treatment and 6 were discontinued The causes of discontinuation included: adverse events (n = 3), disease progression (n = 1), patient decision (n = 1), discontinuation of treatment for more than 6 weeks (n = 1) As a first-line treatment for advanced ESCC, cs1001 combined with CF chemotherapy has good antitumor activity and long-term remission The objective remission rate (ORR) has reached 77.8% (14 / 18) At the time of data cut-off, all patients with remission had no progress Of the 23 patients who received treatment, 18 were included in the efficacy analysis and 5 were not included because the first assessment after baseline was not achieved Among the 18 patients whose curative effect can be evaluated, 14 patients (77.8%) got partial remission (PR), 11 of them were still in treatment and 3 of them were stopped due to adverse events The duration of remission (DOR) ranged from 0.03 to 8.4 + months, and the median dor was not reached Of these 14 patients, 13 observed remission at the first tumor assessment (week 9) after baseline The median duration of cs1001 treatment was 131 days (range: 3-313), and 18 cases (78.3%) had adverse events (teae) of grade 3 or above The most common adverse events associated with CF based chemotherapy regimens include anemia, neutropenia, leukopenia, nausea, and anorexia Three patients (13.0%) stopped treatment due to adverse events, one of them (hyponatremia) was related to cs1001 treatment One patient (4.3%) had an adverse event leading to death (multiple organ dysfunction syndrome), which was assessed not to be related to combination therapy 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 critical phase II tests and three phase III tests for multiple cancer species Source of the original text: 2019 CSCO | cstone announcements promising trial data on its anti-PD-L1 antibodity in esophageal squamous cell carcinoma with an orr of 77.8%