The results of Phase III of the first-line treatment of non-squamous non-small cell lung cancer were published.

Xinda Biopharmaceuticals, a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as cancer, metabolic diseases, autoimmune diseases, and Lilly Pharmaceuticals (NYSE: LLY) today announced the results of the ORIENT-11 study in the form of an oral presentation at the 21st World Lung Cancer Congress (IASLCWCLC) Online Theme Forum (VirtualPresidential Symposium).
the same time, the results were selected by Journal of Journal of Theracic 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 that compares Dabershu ® (sedili monoanti-injection) or placebo combined pyrethroids ® (injected with pyrethromycin) and platinum for advanced or recurrent non-squamous non-small cell lung cancer without EGFR-sensitive mutations or ALK gene rearrests.
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, and the trial and control groups were assessed by the Independent Imaging Review Board (IRRC) with a mid-progress life (PFS) of 8.9 months, respectively. 9 months and 5.0 months, HR (95%CI) s 0.482 (0.362, 0.643), P.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 Li, 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. 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 survival of patients who received the Dabershu ® tumor immunotherapy in combination with traditional chemotherapy as a first-line therapy compared to patients who received 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.
Li, Senior Vice President of Lilly China and Head of the Center for Drug Development and Medical Affairs, said, "The release of the ORIENT-11 study at this year's WCLC is in itself a major positive for the study."
the results of this published ORIENT-11 study are encouraging and will drive the process of layout of the Dabershu ® (Sindilli 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.
" about non-scale non-small cell lung cancer Lung cancer is China's current morbidity and mortality rate are the number one 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.
study on ORIENT-11 study ORIENT-11 is an assessment of The Daberschu ® (Sedili monoanti-injection) or placebo combined force pyrethroids ® (injection-based pyrethromycesser) Second sodium) and platinum for the effectiveness and safety of first-line treatment of advanced or recurrent non-squamous non-small cell lung cancer in randomized, double-blind, Phase III controlled clinical studies (ClinicalTrials.gov, NCT03607539).
the main study endpoint was Progressless Survival (PFS) assessed by the Independent Imaging Review Board on the basis of reCISTv 1.1.
secondary study endpoints include total lifetime (OS), safety, and so on.
The study included 397 subjects who were randomly grouped at 2:1 and received 200mg of Daberschu ® (Sedili monoanti injection) or placebo combined pyrethroids ® (injected with pyrethromycosin) and platinum therapy, respectively , given once every 3 weeks, after completing 4 cycles of treatment, enter the maintenance phase of Dabershu ® (Sedili monoanti injection) or placebo combined pyrethromycin ® (injected with pyrethromycin) until the disease progresses, 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 The Dabershu ® (Sindilli Mono-Injection) Dabershu ® (Sindilli Mono-Injection) is an innovative biopharmaceutical of international quality developed jointly by Syntech Biopharmaceuticals and Lilly Pharmaceuticals 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 The PD-1/procedural death receptonic ligand 1 (Programmed Death-Ligand1, PD-L1) path, which causes tumor immunity tolerance, reactivates the anti-tumor activity of lymphocytes for the purpose 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.
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