2020 WCLC: Stage III data on the first-line treatment of non-squamous non-small cell lung cancer in combination with chemotherapy by Dabsch? (Sinead-Li mono-injection) is encouraging.

On August 8, 2020, Lilly Pharma (NYSE: LLY) and Syntech Biopharmaceuticals jointly announced that the results of the 21st World Lung Cancer Congress (IASLC WCLC) Online Theme Forum (IASLC WCLC) 2020 were published in oral form as an oral report on the results of the ORIENT-11 study.
, the results were selected by Journal of Journal of Thoracic Oncology, a leading international journal in the field of lung cancer, and published online on the same day.
The purpose of this study was to evaluate the efficacy of the innovative PD-1 inhibitor Dabershu ® (Sedili mono-injection) combined with Pythre ® (injected with pemethase glycosate) and platinum chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (NSCLC).
ORIENT-11 is a randomized, double-blind, Phase III controlled clinical study of first-line treatment for late-stage or recurrent non-squamous non-small cell lung cancer in the form of Daberschu ® (Sedili monoanti-injection) or placebo-combined pyrethromycin ® (injected with phosphate®
Based on an in-period analysis conducted by the Independent Data Monitoring Committee (IDMC), the Dabershu ® (Sindilli mono-injection) combined force bithal ® (injection-based pyrethromysterone) and the platinum-based comparative placebo combined pyrethroid® (injected permeate glycosate) and platinum significantly extended the pre-progress survival (PFS) to achieve pre-set quality-of-life standards.
The mid-term analysis data cut-off period was 8.9 months, while the trial and control groups were assessed by the Independent Imaging Review Board (IRRC) with a mid-progress non-progressable survival period (PFS) of 8.9 months and 5.0 months, respectively, and HR (95% CI) of 0.482 (0.362), 0.643), P 0.00001.
The medium total survival (OS) of the two groups had not yet been achieved, and the Sedili monoantigen combined chemotherapy group had an increase in OS compared to the placebo combined chemotherapy group (HR?0.609,95%CI:0.400-0.926).
The confirmed objective remission rate (ORR) assessed by the IRRC increased from 29.8% to 51.9%, and Sedili monoantigen combined chemotherapy obtained objective remission earlier than placebo combined chemotherapy (up to 1.51 months vs. 2.63 months).
safety characteristics are consistent with previously reported findings of ® (Sidili monoindration injections) and there are no new safety signals.
The National Drug Administration (NMPA) has formally accepted the new adaptation application (sNDA). "According to data released by the National Cancer Center in 2019, lung cancer morbidity and mortality are currently the highest among all cancers," said Professor Zhang Zhang, lead researcher on the
ORIENT-11 study.
for patients who drive gene-negative, immunotherapy combined chemotherapy has become one of the first-line standard treatments.
ORIENT-11 study confirmed that ® combination chemotherapy (Sidilli mono-injection) can significantly delay disease progression in this patient population.
are proud to share this finding on this year's WCLC online theme forum as one of the few oral presentations.
, senior vice president of Lilly China and head of the Center for Drug Development and Medical Affairs, said, "The fact that the results of ORIENT-11 will be published at this year's WCLC is in itself a major positive for the study."
the results of this published ORIENT-11 study are exciting and will drive the process of layout of the Dabershu ® (Sudili mono-injection) in the field of first-line NSCLC therapy.
we look forward to the early approval of this adaptation, benefiting more lung cancer patients in China, so that such patients and families can see the hope of life. Dr. Hui Zhou, Vice President, Biomedical Science and Strategic Oncology,
, said, "The results of ORIENT-11 show a significant improvement in the total and non-progressive lifetimes of patients receiving Dabershu ® (Sindilli monoin injection) tumor immunotherapy combined with traditional chemotherapy as a first-line therapy compared to patients receiving chemotherapy alone.
would like to express our sincere gratitude to the patients and researchers involved in the ORIENT-11 trial for their important contribution to this landmark study.
" on non-scale non-small cell lung cancer is China's current morbidity and mortality rate are ranked first in malignant tumors.
small cell lung cancer (NSCLC) accounts for about 80 to 85 percent of all lung cancers, and about 70 percent of NSCLC patients are diagnosed with local advanced or metastatic tumors that are not suitable for root surgery.
same time, a significant proportion of early NSCLC patients undergoing surgery have relapses or distant metastasis and later die as a result of the progression of the disease.
About 70% of NSCLC patients in China are non-scaly NSCLCs, of which nearly 50% of NSCLC patients do not have EGFR sensitive mutations or ALK gene rearration, this part of advanced lung cancer patients are not suitable for targeted treatment, treatment methods are limited, there are huge unsatisfied medical needs.
Orient-11 Study ORIENT-11 Study is a randomized, double-blind, Phase III controlled clinical study evaluating the effectiveness and safety of the first-line treatment of advanced or recurrent non-squamous non-small cell lung cancer (ClinicalTrials.gov) by evaluating the effectiveness and safety of The Daberschu ® (Xindily monoanti injection) or placebo-combined Pythretone ® (injected with Pemexate) and platinum for advanced or recurrent non-squamous non-small cell lung cancer NCT03607539).
study endpoint was progressless survival (PFS) assessed by the Independent Imaging Review Board on the basis of the RECIST v1.1 criteria.
secondary study endpoints include total lifetime (OS), safety, and so on.
orient-11 study was not designed to confirm statistically significant improvements in OS.
The study included 397 subjects who were randomly grouped at 2:1 and received 200mg of Daberschu ® (Sedili monoanti injections) or a placebo combined pyrethroid® (injectable pyrethromycosin) and platinum therapy, respectively. , given once every 3 weeks, after completing 4 cycles of treatment, enter the D'Aberschu ® (Sedili monoanti injection) or placebo combined pyrethromycin ® (injection of pyrethromycin) maintenance phase, treatment until the progression of the disease, toxic intolerance or other conditions requiring termination of treatment.
the progression of the disease in the control group can be conditionally crossed to ® (Sudili mono-injection) single-drug treatment.
About Dabershu ® (Sidili Mono-Injection) Dabershu ® (Syndically Mono-Injection) is an innovative biopharmaceutical of international quality developed jointly by Lilly Pharmaceuticals and Syntech Biopharmaceuticals in China.
the first adaptive disorder approved was recurrent/incurable classic Hodgkin's lymphoma, and was selected in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of lymphoma.
the 2019 Health Insurance State ®, The only PD-1 inhibitor to enter national health insurance.
In April 2020, the NMPA formally accepted applications for new adaptations to the first-line treatment of non-squamous non-small cell lung cancer by Dabershu ® (Sindilli mono-injection) combined libitai ® (injection of pyrethromycin) and platinum chemotherapy for first-line treatment of non-squamous non-small cell lung cancer®; Dilli monoanti injections) combined with Health Choices ® (injection with gisitabin) and platinum chemotherapy first-line treatment of squamous non-small cell lung cancer Phase III study reached the main research end point, Dabershu ® (Sindili single anti-injection fluid) single-drug second-line treatment of advanced /metastatic esophageal squamous cancer ORIENT-2 research reached the main research endpoint.
Dabershu® (Sedili monoanti injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking PD-1/procedural death receptacles 1 (Programmed Death-Ligand 1), which causes tumor immune tolerance. PD-L1) path, reactivates the anti-tumor activity of lymphocytes, thus achieving the goal of treating tumors.
more than two dozen clinical studies, more than 10 of which are registered clinical trials, are currently under way to assess the anti-tumor effects of Sudili monoantigen on a wide range of solid and blood tumors.
is also conducting clinical research on Siddile monoanti injections worldwide.
source: MedSci !-- end of content presentation -- !-- to determine if the login ends.