Dabershu ® combine health-selected ® and platinum chemotherapy first-line treatment of squamous non-small cell lung cancer Phase III study obtained positive data, significantly prolonged the non-progressive survival!

May 7, 2020, Lilly Pharmaceuticals (NYSE: LLY) and Cinda Biopharma jointly announced: A randomized, double-blind, Phase III controlled clinical study (ORIENT-12) of the innovative PD-1 inhibitor Damerschu ®
(Sindilli monoantigen) developed by the two companies Dabershu ®
(Sindili mono-anti-injection, referred to as Sindilli mono-resistance) joint health-choice ®
(injection with Gisitabin, referred to as Gisitambin) and platinum chemotherapy for advanced or metastatic squamous non-small cell lung cancer (NSCLC) first-line treatment reached the main research endpoint This is the world's first randomized, double-blind, phase III clinical study evaluating PD-1 antibody combination health-selected ®
(injected with gisitabine) and platinum for first-line treatment of scaly NSCLC studies showed that Sindilli monoantigen combined with platinum compared to placebo and platinum, significantly prolonged progression-free survival (PFS), reached a preset research endpoint, PFS significantly benefited, safety characteristics were consistent with previously reported Sindilli monoantigen studies, no new safety signals Detailed findings will be presented at subsequent academic meetings Lilly and Cinda plan to communicate with the National Drug Administration Drug Review Center (CDE) for new indications listing applications submitted to Cindy's single-resistant joint Gisitabin and platinum for first-line treatment of scaly NSCLC "Lung cancer accounts for the first leading cause of cancer death (25.2%), of which NSCLC accounts for about 80% to 85%, " said Professor Zhou Caixuan, Director of Oncology Department, Shanghai , About 35% of NSCLC is scaly NSCLC In the past two decades, the drug advances in the treatment of NSCLC have been mainly concentrated in non-scaly NSCLC, whereas the development of drugs has been slow due to the lack of drive genes and the special biological characteristics of tumors The emergence of anti-PD-1 antibodies has brought new treatments to this class of patients We see that the sindili monoantigen study reached the pre-set end of the main study The ORIENT-12 study used different combination chemotherapy protocols compared to the KEYNOTE-407 study of Pablo bezumab, and was the first randomized controlled study in the world to confirm that PD-1 antibodies combined with gisitabine and platinum could significantly improve the benefits of non-progressive survival in patients with first-line scaly NSCLC "Not long ago, the National Drug Administration's Drug Review Center (CDE) accepted xindili monoantigen synth for new indications for first-line treatment of non-squamous non-small cell lung cancer (nqNSCLC), " said Dr Li Wang, senior vice president of Lilly China and head of the Center for Drug Development and Medical Affairs The exciting results of this ORIENT-12 study also demonstrate the potential of Sindy lizumab in the field of squamous non-small cell lung cancer treatment We would like to thank all the participants and their families involved in this study, researchers and clinical trial centers, as well as Cinda's colleagues We look forward to bringing this new treatment to lung cancer patients in China as soon as possible in the future "At present, Cindy monoresist is the only anti-PD-1 monoclonal antibody drug included in the national health insurance list," said Dr Zhou Hui, Vice President of Medical Science and Strategic Oncology, Cinda Biopharmaceutical Group It was approved by the National Drug Administration in 2018 for treatment of at least a recurrent or incurable classic Hodgkin's lymphoma after at least second-line system chemotherapy We are currently conducting a randomized controlled study of multiple stageIII randomized controlled studies of lung cancer in Sindyli monoantigen THE ORIENT-12 RESULTS ARE ENCOURAGING, AND WE FORESEE THE POTENTIAL OF SINDILLI MONOANTIGEN TO REACH MORE LUNG CANCER PATIENTS This is also the second successful randomized controlled study of lung cancer after Cinda Bio reached the main end of the study after ORIENT-11 (first-line non-scale NSCLC randomized, double-blind, phase III study, NCT03607539) "
on orIENT-12 ORIENT-12 study is a randomized, double-blind, phase III controlled clinical study (ClinicalTrial.gov, NCT0629925) of The ®
(Sindyli monoantigen) or placebo combined health-like ®
(injection with gisitabine) and platinum for the effectiveness and safety of late-stage or metastatic scaly NSCLC first-line therapy The main research endpoint was Progressionless Survival (PFS), assessed by the Independent Imaging Review Board (IRRC) in accordance with the RECIST v1.1 standard Secondary research endpoints include total lifetime (OS), security, and so on a total of 357 subjects in this study, according to 1:1 randomized group, received Daboshu ®
(Sindilli mono-injection) 200mg or placebo combined with the ®
(injection with gisitabine) and Platinum treatment, 1 per 3 weeks, after completing 4 or 6 cycles of combined treatment, enters the Damershu ®
(Sindili monoantigen) or placebo-maintained treatment until the disease progresses, toxic intolerance, or other conditions that require termination of treatment After the progression of the disease in the control group, it is conditionally crossed to Damershu ®
(Sindili mono-anti-injection) single-drug treatment on squamous non-small cell lung cancer (qNSCLC) lung cancer is the highest incidence and mortality rate in China In all lung cancer, NSCLC accounts for about 80% to 85%, and about 70% of NSCLC patients are diagnosed with pre-localized advanced or metastatic tumors that are not suitable for curative surgery At the same time, a significant proportion of early NSCLC patients undergoing surgery will have relapse or distant metastasis, and later died as a result of the progression of the disease About 35% of The patients of NSCLC in China are scaly NSCLC, scaly NSCLC lacks the driving gene, and the effective rate of first-line chemotherapy is about 30% Currently, only Pablo beads have been approved by the FDA and the National Drug Administration (NMPA) for use in this population Treatment is still limited and there are huge unmet medical needs on The Dapershu ® (Sindili monoire) Dabershu ®
(Sindili mono-injection) is an international-quality innovative biopharmaceutical developed by Lilly Pharmaceuticals and Sinda Biopharma in China Its first approved indication was recurrent/incurable classic Hodgkin's lymphoma and was selected in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma guidelines In April 2020, the State Drug Administration (NMPA) formally accepted the application for an indication of the first-line treatment of Dabo shu
®
(Sindili monoantigen) for first-line treatment of non-squamous non-small cell lung cancer (nqNSCLC) In the 2019 health care talk, Dabershu ®
(Sindili mono-injection) is the only PD-1 inhibitor to enter the national health insurance Daboschu ®
(Sindyli monoantigen) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thus blocking the PD-1/programmed death receptor ligation 1 (Programmed Death-Ligand 1, PD-L1) pathway that causes tumor immunity to reactivate the anti-tumor activity of lymphocytes More than 20 clinical studies( more than 10 of which are registered clinical trials) are currently under way to explore the anti-tumor effects of Sindy Li monoantigen sondy monotonous on other solid tumors Cinda Bio is also conducting clinical research on Sindy Li monoantigen injections in the United States statement: The indication is the use of drugs in the study, has not been approved in China