Keystone Pharmaceuticals anti-PD-L1 single-anti-first-line treatment of non-small cell lung cancer market application was accepted by NMPA

The NDA's acceptance is based on a Phase 3 clinical study of Shugli monoantigen combination chemotherapy for first-line treatment of scaly and non-scaly NSCLC patients with CS1001-302.
As reported in August this year, the clinical trial, in a planned in-period analysis, was assessed by the Independent Data Monitoring Board (iDMC) to have reached the predetermed main study endpoint, i.e. Shugli monoantigen combination chemotherapy significantly extended progression-free survival (PFS) compared to placebo combination chemotherapy, reducing the risk of disease progression or death by 50 percent.
subgroup analysis showed that patients with scaly and non-scaly NSCLC, PD-L1 expression, and PD-L1 expression, and 1 percent of patients showed clinical benefits.
the safety of Schugli monoantigen combination chemotherapy was good and no new safety signals were found.
detailed clinical trial data will be reported orally at the Late-Breaking Abstract session of the ESMO ASIA meeting on November 21.
incidence of lung cancer has continued to grow in China in recent years.
reported that there will be about 770,000 new cases of lung cancer in China in 2018.
also in 2018, there were about 690,000 lung cancer-caused deaths in China.
lung cancer is the leading cause of cancer-related deaths in both male and female cancer patients.
, non-small cell lung cancer accounts for the majority of lung cancer.
there is no anti-PD-L1 single anti-approved for IV period NSCLC.
CS1001-302 Study CS1001-302 is a multi-center, randomized, double-blind Phase 3 clinical trial (CS1001-302; clinicaltrials.gov registration number: NCT03789604; Drug Clinical Trial Registration No.: CTR20181452) is designed to assess the effectiveness and safety of CS1001 combined chemotherapy in patients without first-line treatment, phase IV NSCLC.
the main endpoint of the trial is the PFS evaluated by the researchers, the secondary endpoint includes the total lifetime, the PFS and safety of biCR evaluation, etc.
about Shugli monoanti-Sugley monoanti is developed by Keystone Pharmaceuticals in the study of anti-PD-L1 monoclonal antibodies.
the development of Shugli monoanti is based on the OmniRat, a genetically modified animal platform authorized ® Company of the United States.
the platform can produce all-human antibodies in one stop.
as an all-human source full-length anti-PD-L1 monoclonal antibody, Shugli monoanti is a natural G-type immunoglobulin 4 (IgG4) monoantigen closest to the human body.
is associated with a lower risk of immunogenicity and associated toxicity in patients, which gives Shugli monoantigen a potentially unique advantage over similar drugs, according to a keystone pharmaceutical press release.
Shugli monoanti has completed phase 1 clinical trial dose climbing in China.
in phases 1a and 1b, Shugli monoantigens showed good anti-tumor activity and tolerability in several adaptation certificates.
Currently, Shugli monoantigen is conducting a number of clinical trials, in addition to a U.S. Bridging Phase 1 study, in China, Shugli monoantigen is conducting a multi-arm Phase 1b clinical trial for multiple cancer species, a Phase 2 registered clinical trial for lymphoma, and four Phase III registered clinical trials for Stage III, Phase IV.
phase 3 clinical trials of patients with Shugli single anti-treatment phase IV non-small cell lung cancer reached the main endpoint, and the listing application has been accepted by the State Drug Administration.
: The State Drug Administration has announced that it has accepted applications for the listing of a new drug for the first-line treatment of non-small cell lung cancer. Retrieved 2020-11-12, from Source: Supplied