Domestic PD-L1 antibodies! Keystone Pharmaceutical CS1001 first-line treatment iv stage NON-small cell lung cancer Phase III clinical success, to submit a listing application!

August 10, 2020 // -- Keystone Pharmaceuticals recently announced the evaluation of anti-PD-L1 monoantigenic CS1001 injection (hereinafter referred to as "CS1001") combined chemotherapy first-line treatment of stage IV non-small cell lung cancer Phase III clinical trial CS1001-302 in patients with NSCLC, in the planned mid-term analysis, was evaluated by the Independent Data Monitoring Committee (iDMC) and reached the preset main research endpoint, the results were statistically significant and clinically significant.
compared to placebo-plus chemotherapy, CS1001 plus chemotherapy significantly extended progression-free survival (PFS), reducing the risk of disease progression or death by 50 percent.
CS1001-302 is a multi-center, randomized, double-blind Phase III clinical trial (clinicaltrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) designed to evaluate the effectiveness and safety of CS1001 combined chemotherapy contrast placebo combination chemotherapy in patients with no first-line treatment, phase IV NSCLC.
the main endpoints of the experiment were progress-free survival (PFS) assessed by the researchers, and the secondary endpoints included total survival (OS), PFS and safety assessed by BICR.
results showed that(1) in all patients with squamous and non-scaly NSCLCs, the researchers assessed a PFS risk ratio of 0.5 (0.39, 0.64), p.lt;0.0001 to HR (95% CI).
PFS in the CS1001 plus chemotherapy group was 7.8 months and the placebo plus chemotherapy group with 4.9 months.
(2) subgroup analysis showed that patients with squamous and non-scaly NSCLC, PD-L1 expression and PD-L1 expression showed clinical benefits.
PFS results evaluated by the Independent Center for Blindness Review (BICR) were consistent with the main study endpoints.
(4) other secondary endpoint data also support the main study endpoint results.
(5) CS1001 combined chemotherapy is safe and no new safety signals have been found.
noteworthy, CS1001-302 is the world's first randomized double-blind Phase III study of the success of anti-PD-L1 monotherapy in advanced NSCLC.
Compared to other published results of anti-PD-1/PD-L1 monoantigenic combination chemotherapy in first-line NSCLC studies, the CS1001-302 study adopted an innovative design and was the first first phase III clinical trial in China to cover both scale and non-scale NSCLC substyles.
results confirmed that CS1001 combined chemotherapy significantly improved PFS and was safe in patients with squamous and non-scaly NSCLC.
The cornerstone pharmaceutical industry plans to submit to the National Drug Administration (NMPA) a new drug for CS1001 combined chemotherapy first-line treatment of NSCLC adaptive disorders.
, there is no anti-PD-L1 monoa resistance approved for phase IV NSCLC.
CS1001 is the first confirmed combination chemotherapy in China to significantly improve the anti-PD-L1 monotherapy of PFS in NSCLC patients in China, and is expected to become the world's first combination chemotherapy at the same time approved squamous and non-scaly NSCLC first-line treatment of anti-PD-L1 monotherapy.
CS1001 was developed by Keystone Pharmaceuticals in the study of anti-PD-L1 monoclonal antibodies.
CS1001 is produced by the OmniRat®GMOD animal platform, which is licensed byLigand Corporation of the United States, and enables one-stop production of all-human antibodies.
as an all-human full-length anti-PD-L1 monoclonal antibody, CS1001 is a natural G-type immunoglobulin 4 (IgG4) monotherapy drug closest to the human body.
CS1001 has a unique safety advantage because it has a lower risk of immunogenicity and associated toxicity in patients than similar drugs.
CS1001 showed good anti-tumor activity and tolerability in many tumor species.
() Source: Keystone Pharmaceuticals.