First-line immunotherapy for lung cancer! Synda Bio/Lilly Daberschu ® treatment of non-squamous non-small cell lung cancer Phase III clinical success!

09, 2020 // -- Innovent Biologics and Eli Lilly recently jointly announced the results of an oral presentation at the 21st World Lung Cancer Congress (IASLC WCLC) Online Theme Forum (IASLC WCLC) in the form of an oral report.
The purpose of this study was to evaluate the efficacy of the innovative PD-1 inhibitor Dabershu ® (Sedili monoanti-injection) combined with pyrethroid ® (injected with pyrethromycin) 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 compared Daberschu ®or placebo combined force bitai® and platinum for advanced or recurrent non-scaly NSCLC first-line therapy without EGFR-sensitive mutations or ALK gene rearring.
Based on an in-period analysis conducted by the Independent Data Monitoring Committee (IDMC), the Daberschu ®-Libitai®-platinum group (trial group) had significantly extended its progression-free survival (PFS) compared to the placebo-libitai®-platinum group (control group), which met the preset criteria for eugenicity.
The mid-term analysis data cut-off period was 8.9 months, and the pilot and control groups were assessed by the Independent Imaging Review Board (IRRC) for 8.9 months and 5.0 months, respectively (HR-0.482; 95% CI:0.362-0.643; p.00001).
total survival (OS) in the two groups had not yet been achieved, and the experimental group had improved compared to the control group OS (HR?0.609; 95%CI:0.400-0.926).
The confirmed objective mitigation rate (ORR) assessed by the IRRC was higher in the trial group than in the control group (ORR: 51.9% vs 29.8%), and the objective remission was obtained earlier in the trial group (up to 1.51 months vs 2.63 months) than the control group.
safety characteristics are consistent with previously reported ®, and there are no new safety signals.
The National Drug Administration (NMPA) has formally accepted the new adaptation application (sNDA).
lung cancer is currently the leading incidence and mortality rate among all cancers, according to data released by the National Cancer Center in 2019.
for patients who drive gene-negative, immunotherapy combined chemotherapy has become one of the first-line standard treatments.
ORIENT-11 study confirmed that Dabershu® combination chemotherapy can bring significant clinical benefits to the patient population, with significant improvements in both total and non-progressional survival.
the results of this study are exciting and will drive the process of ® in the field of first-line NSCLC therapy.
the adaptation is approved, it will benefit more lung cancer patients in China and give them and their families hope for life, " he said.
cancer is the number one malignant tumor in China in both morbidity and mortality.
small cell lung cancer (NSCLC) accounts for about 80%-85% of all lung cancers, and about 70% of NSCLC patients are already diagnosed with endostatic 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.
D'® 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 only PD-1 inhibitor to enter ® national health care program in the 2019 health care talks.
In April 2020, the NMPA formally accepted applications for new adaptations to the first-line treatment of non-scaly NSCLC with Dabershu ® Combined Libitai® and platinum chemotherapy® The phase III study of ® (Gissidabin for injection) and platinum chemotherapy first-line treatment of squamous NSCLC reached the main research end point, and the ORIENT-2 study of Dabshu® single-drug second-line treatment of advanced/metastatic esophageal squamous cancer reached the main research endpoint.
Dabershu® 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 receptacle 1 (PD-L1) path that causes tumor immune tolerance and reactivating 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.
() Source: Xinda Creatures.