On May 9, 2020 Cinda Biopharmaceutical (Hong Kong Stock Exchange: 01801), an innovative drug dedicated to the development, production and sale of major diseases such as cancer, autoimmunity, metabolic diseases, etc. The biopharmaceutical company, and Eli Lilly (NYSE: LLY) reported : A randomized, innovative, and innovative PD-1 inhibitor Daboshu (Sindilimumab Injection) jointly developed by the two parties (Press release, Innovent Biologics, MAY 9, 2020, View Source [SID1234557375]). Double-blind, phase III controlled clinical study (ORIENT-12)-Daboshu (sindilimumab injection, hereinafter referred to as sinidiumab) combined with Gemcitabine (gemcitabine for injection, hereinafter referred to as gemcitabine) Platinum-based chemotherapy is used in the first-line treatment of advanced or metastatic squamous non-small cell lung cancer (NSCLC) to reach the primary study endpoint. This is the world ’s first randomized, double-blind, phase III clinical study evaluating PD-1 antibody combined with Gemcitabine (gemcitabine) and platinum for first-line treatment of squamous NSCLC.

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Studies have shown that Sindilimum combined with gemcitabine and platinum compared with placebo combined with gemcitabine and platinum, significantly prolonged progression-free survival (PFS), reached the preset study endpoint, PFS significantly benefited, safety characteristics and previous reports The research results of xindilimumab were consistent and there was no new safety signal. Detailed research results will be announced in subsequent academic conferences.

Cinda and Eli Lilly plan to communicate with the Drug Evaluation Center (CDE) of the State Drug Administration on the submission of a new indication for the application of cindilimumab combined with gemcitabine and platinum for first-line treatment of squamous NSCLC.

Professor Zhou Caicun, director of the Department of Oncology, Shanghai Pulmonary Hospital, said: "Lung cancer accounts for the first cause (25.2%) of all cancer deaths, of which NSCLC accounts for approximately 80% to 85%. About 35% of NSCLC are squamous NSCLC. Over the past two decades, the development of drugs for the treatment of NSCLC has mainly focused on non-squamous NSCLC. Due to the lack of driver genes and special tumor biological characteristics, drug development has been slow. The emergence of anti-PD-1 antibodies is This type of patient brings a new treatment. We see that the study of Sindilimum reached the preset primary study end point. The ORIENT-12 study compared with the KEYNOTE-407 study of pabolizumab Using different combination chemotherapy regimens, it is the first randomized controlled study in the world to confirm that PD-1 antibody combined with gemcitabine and platinum can significantly improve the benefit of progression-free survival in patients with first-line squamous NSCLC. "

Dr. Hui Zhou, Vice President of the Medical Science and Strategic Oncology Department of Cinda Biopharmaceutical Group, said: "Currently Cindylimumab is the only anti-PD-1 monoclonal antibody drug listed in the National Medical Insurance List. It was awarded the National Drug Administration in 2018 Approved by the Administration for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line chemotherapy. We are currently conducting a number of phase III randomized controlled studies on Sindrinimab. ORIENT-12 The results of the study are encouraging, and we foresee the potential of Sindilimumab to benefit more lung cancer patients. This is also the main study of Cinda Biological following ORIENT-11 (first-line non-squamous NSCLC randomized, double-blind, phase III study, NCT03607539) After the end point, the second successful randomized controlled study of lung cancer. "

Dr. Li Wang, senior vice president of Eli Lilly China and head of the Center for Drug Development and Medical Affairs, said, "Not long ago, the Drug Evaluation Center (CDE) of the State Drug Administration accepted Cindilimum for non-squamous non-small The application of new indications for first-line treatment of cell lung cancer (nsqNSCLC). And the exciting research results of ORIENT-12 have reflected the potential of Sindilimumab in the treatment of squamous non-small cell lung cancer. Here we think Thanks to all the patients and their families, researchers and clinical trial centers, and Cinda colleagues who participated in the study. We look forward to bringing this new treatment to lung cancer patients in China as soon as possible. "

About ORIENT-12 research

The ORIENT-12 study is a randomized evaluation of the efficacy and safety of Daboshu (sintilimab) or placebo in combination with Gemcitabine (gemcitabine) and platinum for first-line treatment of advanced or metastatic squamous NSCLC , Double-blind, Phase III controlled clinical study (ClinicalTrials.gov, NCT03629925). The primary study endpoint was progression-free survival (PFS) assessed by the Independent Imaging Review Committee (IRRC) according to the RECIST v1.1 standard. Secondary study endpoints include overall survival (OS) and safety.

A total of 357 subjects were enrolled in this study. They were randomized 1: 1 and received Daboshu (Sintilimab injection) 200 mg or placebo in combination with Gemcitabine (gemcitabine for injection) and platinum Treatment, given once every 3 weeks, after completing 4 or 6 cycles of combination therapy, enter Daboshu (sindilimumab injection) or placebo for maintenance therapy until disease progression, toxicity intolerance or other Circumstances where treatment needs to be terminated. After the disease progresses in the control group, it can be conditionally crossed to monotherapy of daboshu (sintilimab injection).

About squamous non-small cell lung cancer (sqNSCLC)

Lung cancer is the first malignant tumor in China that ranks first in both morbidity and mortality. NSCLC accounts for about 80% to 85% of all lung cancers, and about 70% of NSCLC patients are diagnosed as locally advanced or metastatic tumors that are not suitable for radical surgery. At the same time, a considerable proportion of early-stage NSCLC patients undergoing surgery will have recurrence or distant metastasis, and then die due to disease progression. About 35% of Chinese patients with NSCLC are squamous NSCLC. Squamous NSCLC lacks driver genes, and the effectiveness of first-line chemotherapy is about 30%. At present, only paclizumab combined with carboplatin and paclitaxel has been approved by the FDA and the National Drug Administration (NMPA) for this population. Treatment is still limited, and there are huge unmet medical needs.

About Daboshu (Sintilimab Injection)

Daboshu (Sintilimab Injection) is an innovative biopharmaceutical of international quality jointly developed by Cinda Biopharma and Eli Lilly in China. The first indication for its approval is relapsed / refractory classic Hodgkin’s lymphoma, which was included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines. In April 2020, the National Drug Administration (NMPA) formally accepted the application for indications for the first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC) with dabershu (sintilimab injection). In the medical insurance country talks in 2019, Dabex (Sintilimab Injection) is the only PD-1 inhibitor that enters the National Health Insurance.

Dabshu (Sindilimumab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking tumor immune tolerance The PD-1 / Programmed Death Receptor Ligand 1 (Programmed Death-Ligand 1, PD-L1) pathway reactivates the anti-tumor activity of lymphocytes to achieve the purpose of treating tumors. There are currently more than twenty clinical studies (of which more than 10 are registered clinical trials) are underway to explore the anti-tumor effect of sundilimumab on other solid tumors. Cinda Biotech is also conducting clinical research work on Cindylimumab injections worldwide.