Keystone Pharmaceuticals' anti-PD-L1 mono-anti-CS1001 treatment of Phase IV non-small cell lung cancer patients phase III clinical trials reached the primary endpoint.

Introduction: Keystone Pharmaceuticals plans to submit a new drug listing application (NDA) to the National Drug Administration (NMPA) in the near future.
CS1001-302 is the first anti-PD-L1 mono-anti-combination chemotherapy as a first-line treatment in stage IV squamous and non-scaly non-small cell lung cancer (NSCLC) two tissue subtypes of patients in the phase of randomized double-blind III clinical trial analysis showed that CS1001 combined chemotherapy significantly prolonged progression-free survival (PFS) compared to placebo combined chemotherapy The safety of the joint chemotherapy is good, no new safety signal cornerstone pharmaceutical plan recently submitted to the State Drug Administration (NMPA) new drug listing application (NDA) August 6, 2020, China Suzhou-Keystone Pharmaceuticals (Suzhou) Co., Ltd. (hereinafter referred to as "Keystone Pharmaceuticals" or "Company", Hong Kong Stock Exchange Code: 2616) announced its anti-PD-L1 single anti-CS1001 injection fluid ("CS100" In the planned mid-term analysis of phase III clinical trials of combined chemotherapy for first-line treatment in Phase IV Patients, the results were statistically significant and clinically significant, and the results were statistically significant and clinically significant by the independent data monitoring committee (iDMC) evaluation.
in all patients with scaly and non-scaly NSCLC, the researchers assessed a PFS risk ratio of 0.5 (0.39, 0.64) in HR (95%CI), p-lt;0.0001.
CS1001 secondary PFS for cS1001 combined chemotherapy was 7.8 months, and the center PFS of placebo combined chemotherapy was 4.9 months of subgroup analysis showed that patients with scaly and non-scaly NSCLC, PD-L1 expression, pD-L1 expression, and PD-L1 expression, all showed that the results of pfS evaluated by the ClinicalLy Benefit Blind Independent Center Review Board (BICR) were consistent with the results of the study.
other secondary endpoint data also support the safety of the main study endpoint CS1001 combined chemotherapy, no new safety signal CS1001-302 research lead researcher, Professor Zhou Caixuan, director of oncology at Shanghai Lung Hospital, said: "We are pleased to see cS1001-302 studies in the mid-period analysis of the preset primary research endpoint, CS1001 joint chemotherapy in the inclusion and non-scale NSCLC
it is the world's first random double-blind Phase III study of anti-PD-L1 monoantithe combination chemotherapy in late NSCLC. "At present, there is no anti-PD-L1 monototag approved for IV NSCLC," said Dr. Jiang Ningjun, chairman and chief executive officer of
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CS1001 is the first in China to confirm that combined chemotherapy significantly improved the anti-PD-L1 monotophoid of PFS in NSCLC patients in China, and is expected to become the world's first anti-PD-L1 monotophoid sororifada for simultaneous approval of both squay and non-scaly NSCLC first-line treatment.
this exciting development will further advance the research and development of CS1001 and will be of great significance to the continued commercialization of Keystone Pharmaceuticals. "Compared to other published results of the CS1001-302 study, anti-PD-1/PD-L1 mono-anti-combination chemotherapy in the first-line NSCLC study, using an innovative design, is the first first phase III clinical trial in China that covers both scaly and non-scaly NSCLC subtypes," said Dr. Jianxin Yang, Chief Medical Officer of Keystone Pharmaceuticals,
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as a large Phase III study of nearly 500 patients, it took only 20 months from first-time patient administration to the publication of the main findings, despite intense competition from the group and the effects of new coronary pneumonia.
we will continue to push our full force and evaluate more broadly the efficacy and safety of the product in patients with blood tumors, Stage III NSCLC, advanced stomach cancer, liver cancer, and esophageal cancer.
" Cornerstone Pharmaceuticals plans to submit to the State Drug Administration a new application for the listing of a new drug for the first-line treatment of NSCLC indications for CS1001 combined chemotherapy.
specific research data will be released at a recent academic conference.
the incidence of non-small cell lung cancer has continued to increase in China in recent years.
reported that there will be about 770,000 new cases of lung cancer in China in 2018.
also had about 690,000 lung cancer deaths in China in 2018.
Lung cancer is the leading cause of cancer-related death in both male and female cancer patients.
, non-small cell lung cancer accounts for the majority of lung cancer.
CS1001-302 Study CS1001-302 is a multicenter, randomized, double-blind Phase III clinical trial (CS1001-302; clinicaltrials.gov registration number: NCT0 3789604; Drug Clinical Trial Registration Number: CTR20181452) is designed to assess the effectiveness and safety of CS1001 combined chemotherapy compared to placebo combined chemotherapy in patients with untreated stage IV NSCLC.
the main endpoint of the test was PFS assessed by the researchers; the secondary endpoint included total lifetime, BICR-evaluated PFS, and safety.
about CS1001CS1001 is an anti-PD-L1 monoclonal antibody developed by Keystone Pharmaceuticals.
CS1001 is an OmniRat ® genetically modified animal platform licensed by Ligand, inc., which enables one-stop production of all-human antibodies.
as an all-human source full-length anti-PD-L1 monoclonal antibody, CS1001 is the closest natural G-type immunoglobulin 4 (IgG4) monoanti-drug.
CS1001 has a lower risk of immunogenicity and associated toxicity in patients than similar drugs, giving CS1001 a unique safety advantage.
CS1001 has completed A Phase I clinical trial dose climbing in China.
CS1001 showed good antitumor activity and tolerance in multiple tumor species in Phase Ia and Ib studies.
currently, CS1001 is currently undergoing a number of clinical trials, in addition to a U.S. bridging Phase I study, in China, CS1001 is conducting a multi-arm Ib phase study for multiple cancer strains, two lymphoma registered phase II studies and four phase III registered clinical trials for patients with phase III, IV non-small cell lung cancer, stomach cancer and esophageal cancer.
Keystone Pharmaceuticals (HKEX:2616) is a biopharmaceutical company focused on the development and commercialization of innovative oncology immunotherapy and precision therapy drugs to meet the high medical needs of cancer patients in China and around the world.
was established at the end of 2015 and Keystone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercialization.
company has established a rich product pipeline of 15 tumor candidate drugs, with the combination therapy of tumor immunotherapy as its core.
five late-stage drug candidates are currently in critical clinical trials.
with an experienced management team, extensive pipeline, clinical-focused business model and well-funded funding, Keystone Pharmaceuticals' vision is to become the world's leading biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
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