The results of Sindilla's first-line treatment of non-squamous non-small cell lung cancer were published.

Guide: Cinda Biopharmaceuticals and Lilly Pharmaceuticals jointly announced that the results of the ORIENT-11 study period were presented in oral presentation at the 21st World Lung Cancer Congress (IASLC WCLC) online topic forum (Virtual Presidential Symposium) in 2020.
, Aug. 8, 2020 /PRNewswire/ -- Cinda Biopharma, a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmune, today announced with Lilly Pharmaceuticals (NYSE: LLY) that it will publish its results in oral presentation sedatiques at the 21st World Lung Cancer Congress (IASLCLCLC) online topic forum (VirtualVision.
, the results were selected by JournalofThoracic Oncology, a leading international journal in lung cancer, and published online on the same day.
the purpose of this study to evaluate the efficacy of the innovative PD-1 inhibitor Dabersu ® (Sindili Sepsa Injection) combined with the ® (injection of permian sodium) and platinum chemotherapy to treat non-squamous non-small cell lung cancer (NSCLC).
ORIENT-11 is a randomized, double-blind, Phase III controlled clinical study that compares the ® of Dabersu (Cindilly monobify injection) or the placebo combined libbite ® (injection of pemequal dissin) and platinum for advanced or recurrent non-scaly small cell lung cancer treatment without EGFR sensitivity mutations or ALK gene rearrangements.
an in-time analysis based on the Independent Data Monitoring Board (IDMC), Daberschu ® (Cindilly SEP) combined force bite® (injection with permeitus dsodium) and platinum contrasted placebo combined force bite ® (injection with permeitus dsodium) and platinum, significantly extending the progression-free survival (PFS) to achieve the preset premium criteria.
the mid-term analysis data cut-off date, the median follow-up time was 8.9 months, the trial group and control group were assessed by the Independent Imaging Review Board (IRRC) for the median progression-free survival period (PFS) of 8.9 months and 5.0 months, respectively, and HR (95% CI) was 0.482 (0.362, 0.643), P.00001.
the total lifetime (OS) in both groups was not yet achieved, and the Sindilla-seditcoma group improved compared to the placebo combined chemotherapy group OS (HR.609, 95% CI: 0.400-0.926).
the confirmed objective mitigation rate (ORR) assessed by IRRC increased from 29.8% to 51.9%, sindizumatoscoscombinant chemotherapy was earlier than placebo combined chemotherapy for objective remission (up to 1.51 months vs. 2.63 months).
safety characteristics are consistent with previously reported results from the Daberschu ® (Cindilly Mono-Anti-Injection) and there are no new safety signals.
the National Drug Administration (NMPA) has formally accepted the new indicationapplication application (sNDA). "According to data released by the National Cancer Center in 2019, the incidence and mortality of lung cancer is currently the highest of all cancers," said Professor Zhang Zhang, of the Center for Oncology prevention and control at Sun Yat-
-11.
for patients who drive gene negative, immunotherapy combined chemotherapy has become one of the first-line standard treatments.
ORIENT-11 study confirmed that the combined chemotherapy of the ® dabersu (Cindilly monobifying injection) was able to significantly delay the progression of the disease in the patient population.
we are honored to share this finding as one of the few oral presentations in this year's WCLC Online Topic Forum. "The results of ORIENT-11 show that the total and progression-free survival of patients who received Daberschu ® (Cindilly SYNAS) tumor immunotherapy combined with traditional chemotherapy as first-line therapy significantly improved compared to patients receiving chemotherapy alone," said Dr. Zhou Hui, Vice President of sinda Biomedical Sciences and Strategic Oncology at
.
we would like to express our sincere gratitude to the patients and researchers who participated in the ORIENT-11 trial for their important contribution to this landmark study. "
The publication of the ORIENT-11 results at this year's WCLC is a major affirmation of the study," said Dr. Lili Wang, senior vice president of Lilly China and head of the Center for Drug Development and Medical Affairs at the WCLC this year.
the results of the ORIENT-11 study, published this time, are encouraging and will advance the process of the layout of the Daberschu ® (Cindilly SEP) in the field of first-line NSCLC treatment.
We look forward to the early approval of the indications, which will benefit more lung cancer patients in China, so that such patients and families can see the hope of life.
"About non-scaly non-small cell lung cancer lung cancer is the first malignant tumor in China at present.
about 80% to 85% of non-small cell lung cancer (NSCLC) in all lung cancers, and about 70% of NSCLC patients are already locally advanced or metastatic tumors that are not suitable for root surgery at the time of diagnosis.
, a significant proportion of early NSCLC patients undergoing surgery have relapsed or distant metastasis, and later die as a result of disease progression.
about 70% of NSCLC patients in China were non-scaly NSCLC, of which nearly 50% of NSCLC patients had no EGFR sensitive mutation or ALK gene rearrangement, and this part of patients with advanced lung cancer was not suitable for targeted treatment, limited treatment and there was a huge unmet medical need.
orient-11 study orient-11 is a randomized, double-blind, phase III control clinical study that assessed the effectiveness and safety of the first-line treatment of advanced or recurrent non-small cell lung cancer (Clinicals.gov, NC0360739) to assess the effectiveness and safety of the first-line treatment of the ® of Dabersu (Sindili mono-injection injection) or the placebo joint Libita ® (injection with pemequesinia din) and platinum.
the main research endpoint is Progressless Survival (PFS) assessed by the Independent Imaging Review Board in accordance with the RECISTv1.1 standard.
secondary research endpoints include total lifetime (OS), safety, etc.
397 subjects in the study were treated with a ® of Dabersu (Cindilly Mono-Injection) or 200mg of a placebo combined with a permi®an dsodium and platinum treatment, according to a 2:1 randomized group, respectively, Once a week, after completing 4 cycles of treatment, enter the maintenance phase of the Dabersu ® (Sindili monobify injection) or the placebo joint Libita ® (injection of permeitus dsodium) for treatment until the disease progresses, is not tolerated or otherwise requires termination of treatment.
control group's disease progression may be conditionally crossed to Dabershu ® (Cindilly monobifying injection) single drug treatment.
on Daberschu ® (Cindilly SING) Dabersu ® (Cindilly SINGA) is an innovative biological drug of international quality developed jointly by Cinda Biopharmaceuticals and Lilly Pharmaceuticals in China.
the first indicationiacs approved was recurrent/refractive classic Hodgkin lymphoma, and was selected for the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines.
2019, Dabershu ® (Cindilli monobivable injection) is the only PD-1 inhibitor to enter the state.
April 2020, NMPA officially accepted the application for new indications of the treatment of non-scaly non-small cell lung cancer in the first line of daber®su® (Cindilly Mono-injection injection) joint lybbit®a (injection with permeitus dsodium) and platinum chemotherapy; Lisinga-Sedifainjection) joint lymic® (injection with Gixitabin) and platinum chemotherapy first-line treatment of squamous non-small cell lung cancer Phase III study reached the main research endpoint, Dabershu ® (Cindilly Monobagain injection) single-drug second-line treatment of advanced / metastatic esophagus scale cancer orient-2 study reached the main research endpoint.
Dabersu ® (Sindilli Monodyating Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds specifically to the PD-1 molecule on the surface of the T cell, thus blocking the PD-1/procedural death receptor ligand 1 (Programd-Ligand1, PD-L1) pathway that causes tumor immunity, reactivating the anti-tumor activity of the lymphatic tumor, thus achieving the goal of the treatment.
more than 20 clinical studies, more than 10 of which are registered, are under way to assess the anti-tumor effects of Cindy semaon seditas on various physical and blood tumors.
Cinda Bio is also conducting clinical research on Cindili suprets around the world.
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