Objective remission rate 77.8%! Cornerstone pharmaceutical anti-PD-L1 in patients with esophageal squamous cell carcinoma positive data

Suzhou September 19, 2019 / Meitong news agency / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical" or "company", Hong Kong stock exchange code: 2616) today, at the 22nd National Clinical Oncology Conference and 2019 CSCO academic annual meeting, in the form of oral report, published for the first time in the development of anti-PD-L1 antibody cs1001 in a B-stage esophageal squamous cell carcinoma (E) named gemstone-101 SCC) study data for the cohort The published trial is a dose exploration and expansion study on IA / IB stage, open, multi dose administration for patients with advanced solid tumor or lymphoma in China, aiming to evaluate the safety, tolerance, pharmacokinetics and antitumor efficacy of cs1001 The main purpose of this published cohort study of esophageal squamous cell carcinoma is to preliminarily evaluate the antitumor effect of cs1001 combined with cisplatin and fluorouracil (CF) chemotherapy as the first-line treatment in this kind of patients, and further evaluate the safety and tolerance of cs1001 combined with this chemotherapy Professor Li Jin, director of cancer medicine department, director of CSCO and the reporter of this study, said: "the data of this study shows that in patients with advanced esophageal squamous cell carcinoma, cs1001 combined with CF chemotherapy as the first-line treatment shows good antitumor activity, the objective remission rate reaches 77.8%, and the remission is sustainable, at the same time, the overall safety and tolerance are good OK " Dr Jiang Ningjun, chairman and chief executive officer of cornerstone pharmaceutical, said: "cs1001 is an innovative tumor immunotherapy drug developed for a number of high-risk cancer species in China The esophageal squamous cell carcinoma in this study is also a "Chinese characteristic" malignant tumor The data shows that more than 50% of the new cases and deaths of esophageal cancer in China account for more than 50% in the world, and more than 90% of the patients are squamous cell carcinoma In the face of this severe test, we are very pleased to see the huge therapeutic potential of cs1001 in the preliminary study of esophageal squamous cell carcinoma cohort, and look forward to better performance in the subsequent clinical trials, and become a new treatment option for esophageal squamous cell carcinoma patients as soon as possible " Dr Yang Jianxin, chief medical officer of cornerstone pharmaceutical, said: "at present, most of the first-line treatment of advanced esophageal squamous cell carcinoma is based on platinum containing chemotherapy, but the efficacy is limited, and no immunotherapy drugs have been approved, so patients need effective clinical treatment It's a great pleasure to see that in the phase IB study of esophageal squamous cell carcinoma cohort, the therapeutic effect, safety and tolerance of cs1001 combined with CF chemotherapy have achieved encouraging preliminary data We will continue to promote the clinical development of the treatment scheme in China and constantly tap the potential of cs1001 in drug combination " Summary of gemstone-101ib phase I esophageal squamous cell carcinoma cohort study this cohort study was aimed at patients with advanced esophageal squamous cell carcinoma and had not received systematic anti-tumor treatment for locally advanced or metastatic diseases before Patients received cs10011200mg once every three weeks until the disease progression or intolerable, while patients received cisplatin + fluorouracil once every three weeks, up to six cycles Demographic and baseline characteristics as of July 1, 2019, a total of 23 patients were enrolled in the esophageal squamous cell carcinoma cohort and received study treatment, of which 17 patients were still receiving treatment and 6 patients were terminated The reasons for termination of cs1001 treatment include: adverse events (n = 3), disease progression (n = 1), patient's decision to (n = 1), drug suspension for more than 6 weeks (n = 1), preliminary effectiveness data Cs1001 combined with CF chemotherapy showed good antitumor activity in the treatment of esophageal squamous cell carcinoma The objective remission rate reached 77.8% (14 / 18), and the remission was sustainable As of the data cut-off date, none of the patients in remission had progressed Of the 23 patients who received treatment, 18 were included in the effectiveness analysis set (the remaining 5 patients were not included because they did not reach the first tumor evaluation time) Among them, 14 (77.8%) patients met the partial remission (PR) defined by recistv1.1 standard to achieve disease remission, 11 patients were still receiving treatment, and 3 patients were terminated due to adverse events The duration of remission (DOR) ranged from 0.03 + to 8.4 + months Of the 14 patients who had not yet reached the median remission time, 13 patients occurred in the first tumor assessment (week 9) after baseline The safety data of cs1001 combined with CF chemotherapy regimen were tolerable The median duration of cs1001 treatment was 131 days (range: 3-313 days), and 18 patients (78.3%) had ≥ Level 3 teae, The most common adverse events (trae) associated with CF chemotherapy regimen included anemia, neutropenia, leucopenia, nausea, and loss of appetite in 3 patients (13.0%) who terminated cs1001 due to AE, of which 1 patient (hyponatremia) was associated with cs1001 One patient (4.3%) had an adverse event leading to death (multiple organ dysfunction syndrome), which was not related to the treatment plan after evaluation Cs1001 is an anti-PD-L1 monoclonal antibody 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 About cornerstone Pharmaceutical (HKEx: 2616), a biopharmaceutical company, focuses on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the keen medical needs of cancer patients in China and around the world Founded at the end of 2015, cornerstone pharmaceutical has assembled a world-class management team with rich experience in new drug research and development, clinical research and commercialization Based on the combination therapy, the company has established a powerful tumor drug pipeline consisting of 15 tumor candidate drugs At present, five late candidate drugs are in or close to critical trials With an experienced team, rich pipelines, strong clinical development driven business model and abundant funds, cornerstone pharmaceutical's vision is to become a world-renowned leading Chinese biopharmaceutical company by bringing innovative cancer therapy to cancer patients around the world For more information, please visit www.cstonepharma.com prospective statement the prospective statements made in this article relate only to the events or information on the date of this statement Except as required by law, after the date of making forward-looking statements, we shall not be responsible for updating or publicly modifying any forward-looking statements and unexpected events, whether new information, future events or other circumstances arise Please read this article carefully and understand that our actual future performance or performance may differ significantly from our expectations All statements in this article are made on the publication date of this article and may change due to future development Source: cornerstone pharmaceutical related stock: Hong Kong: 2616 related link: www.cstonepharma.com this article is the reprinted content of yaozhi.com, the copyright belongs to the original author, the purpose of reprinting is to transmit more information, does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.