Immunotherapy for lung cancer! Cinda biology / Lilly: the primary end point of phase III study of cindilimab combined with chemotherapy for non scaly NSCLC!

January 14, 2020 news / BIOON / -- innovent biologics is a biopharmaceutical company dedicated to R & D, production and sales of innovative drugs for the treatment of major diseases such as tumor, autoimmune and metabolic diseases Today, the company and Lilly pharmaceutical jointly announced that they have jointly developed a randomized, double-blind, three-phase controlled clinical study, orient-11 (nct03607539) - Dabusu (cindilimab injection) and libitum (pemetrexed disodium for injection), an innovative PD-1 inhibitor developed by the two parties And platinum were used in advanced or recurrent NSCLC (nsqnsclc) without EGFR sensitive mutation or ALK gene rearrangement Based on the mid-term analysis conducted by the independent data Committee (IDMC), Dabusu ® (cindilimab injection) combined with libitum ® (pemetrexed disodium for injection) and platinum were compared with placebo combined with libitum ® (pemetrexed disodium for injection) and platinum, which significantly prolonged the progression free survival (PFS), reached the preset optimal efficiency standard, safety characteristics and previous reports The results of Dabusu ® (sindilimab injection) were consistent, and there was no new safety signal The results of the research will be announced at a recent academic conference According to the recommendation of the independent data Committee (IDMC), Cinda will initiate discussions with Lilly in the near future on the registration application to the National Drug Administration (nmpa) The incidence rate and mortality rate of lung cancer are ranked first in lung cancer NSCLC accounts for 80% to 85% of all lung cancers About 70% of NSCLC patients are not suitable for radical surgery At the same time, a considerable proportion of early NSCLC patients undergoing surgery will have relapse or distant metastasis, and then die of disease progression About 70% of NSCLC patients in China are non squamous NSCLC, and nearly 50% of NSCLC patients do not have EGFR sensitive mutation or ALK gene rearrangement This part of advanced lung cancer patients are not suitable for targeted treatment, and the treatment methods are limited, and there are huge unmet medical needs "In 2019, the National Cancer Center published the Chinese cancer data in 2015," the professor of internal medicine, director of cancer prevention and treatment center of Zhongshan University "China's cancer data in 2015, the overall incidence rate of lung cancer was 20%, and the mortality rate was about 27% For NSCLC patients without EGFR sensitive mutation or ALK gene rearrangement, they need more treatment options, and the combination of anti-PD-1 monoclonal antibody and chemotherapy has brought greater survival benefits for such patients We are very pleased to see that the study of dabushu ® (sindilimab injection) reached the pre-set primary end point in the interim analysis " Dr Zhou Hui, vice president of medical science and strategic Oncology Department of Xinda biopharmaceutical group, said: "at present, Dabusu (cindilimab injection) is the only anti-PD-1 monoclonal antibody drug listed in the national medical insurance catalog It was approved by the State Drug Administration on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least second-line systemic chemotherapy At present, we are carrying out a number of phase 3 randomized controlled trials of lung cancer The results of the interim analysis of orient-11 are encouraging, and we foresee the ability of Dabusu ® (sindelimab injection) to benefit more lung cancer patients and allow them to spend more time with their families " "The results of this study are encouraging, showing that Dabusu ® (sindilimab injection) combined with libitum ® (pemetrexed disodium for injection) and platinum can significantly delay the progression of disease in such patients It also embodies the commitment of Lilly and Cinda to provide innovative treatment programs for lung cancer patients, "said Dr Wang Li, senior vice president of Lilly China and head of the center for drug development and medical affairs." here we would like to thank all the patients, researchers and clinical trial centers and colleagues of Cinda who participated in this study We look forward to bringing this new treatment scheme to lung cancer patients in China as soon as possible in the future " Orient-11 study: a randomized, double-blind, phase 3 controlled clinical study (ClinicalTrials Gov, nct03607539) to evaluate the efficacy and safety of first-line treatment of advanced or recurrent non squamous non-small cell lung cancer (nsqnsclc) with Dabusu ® (cindilimab injection) or placebo plus libitum ® (pemetrexed disodium for injection) and platinum The primary end point was progression free survival (PFS) assessed by the independent imaging review committee (irrc) according to the RECIST v1.1 standard Secondary endpoints included overall survival (OS), safety, and so on In this study, 397 subjects were randomly divided into two groups according to 2:1 They were treated with 200 mg Dabusu (cindilimab injection) or placebo combined with libitum (pemetrexed sodium for injection) and platinum respectively, once every three weeks After four cycles of treatment, they entered Dabusu (cindilimab injection) or placebo combined with libitum (pemetrexed 2 for injection) Sodium) maintenance phase, treatment until disease progression, intolerable toxicity or other situations requiring termination of treatment In the control group, after the disease progressed, it can cross to Dabusu (sindilimab injection) for single drug treatment Dabushu ® (cindilimab injection): it is an innovative bio drug with international quality jointly developed by Cinda bio pharmaceutical and Lilly pharmaceutical in China Its listing application has been officially approved by the State Drug Administration The first indication approved is relapsed / refractory classic Hodgkin's lymphoma, and it was selected into the 2019 CSCO lymphoma diagnosis and treatment guidelines In the national health insurance talks in 2019, Dabusu ® (cindilimab injection) is the only PD-1 inhibitor with international quality that has entered the national health insurance Dabusu ® (sindilimab injection) is a monoclonal antibody against human immunoglobulin G4 (IgG4), which can specifically bind to the PD-1 molecule on the surface of T cells, thus blocking the PD-1 / programmed death ligand 1 (PD-L1) pathway leading to tumor immune tolerance, reactivating the antitumor activity of lymphocytes, so as to achieve the purpose of tumor treatment At present, more than 20 clinical studies (8 of which are registered clinical trials) are under way to explore the antitumor effect of sindilimab on other solid tumors At the same time, Cinda biology is carrying out clinical research of cindilimab injection in the United States Source: Xinda biology