Hengrui Pharmaceutical PD-1 antibody two first-line therapeutic adaptation phase 3 clinical end of the main study

Karelli pearl monoantigen is an humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceuticals and has intellectual property rights, which can bind to human PD-1 receptors and block the PD-1/PD-L1 path, restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy.
Since it was approved for market in China in May 2019, the drug has been approved in China with four adaptive disorders, covering recurring or recurring classic Hodgkin's lymphoma, advanced hepatocellular carcinoma, local late-stage or metastatic non-squamous non-small cell lung cancer first-line treatment, local late-stage or metastatic esophageal squamous cancer second-line treatment.
the two studies announced to have reached the end of the main study were ESCORT-1st and SHR-1210-III-307.
ESCORT-1st study ESCORT-1st study is a randomized, double-blind, placebo-controlled, multi-center phase 3 clinical study designed to evaluate the effectiveness and safety of contrasting placebo combined yew alcohol and cisplatin, injecting karili-pearl monoantigen and cisplatin for first-line treatment of advanced esophageal cancer, conducted by Professor Xu Ruihua of Sun Yat-sen University-affiliated Oncology Hospital as the lead researcher in more than 60 centers nationwide.
study endpoints are progress-free lifetimes (PFS) and total lifetimes (OS) assessed by the Independent Review Board (BIRC) on the basis of THECIST v1.1 criteria.
secondary study endpoints included PFS, Objective Mitigation Rate (ORR), Mitigation Duration (DoR), Disease Control Rate (DCR), and Safety evaluated by the researchers.
A total of 596 subjects in this study were admitted to a 1:1 randomized group, receiving injections of kariliju monoantigen and cisplatin or placebo combined with sequoia and cisplatin, combined treatment for no more than 6 cycles, followed by injection with carelli pearl monoantigen or placebo maintenance treatment until the disease progresses, toxicity is intosible or other conditions requiring termination of treatment.
results showed that compared with the standard first-line treatment of yew alcohol, the first-line treatment of advanced esophageal cancer patients with carelli's pearl monoantigen and cisplatin was significantly longer than that of patients with non-progressant survival and total survival.
June 2020, Karelli-Zhu single-line anti-second-line treatment of advanced esophageal cancer has been approved by China's State Drug Administration.
According to the press release, the ESCORT-1st study is the first phase 3 randomized, double-blind, placebo-controlled multi-center clinical study of PD-1 monoantigenated combined yew alcohol and cisplatin first-line treatment of advanced esophageal squamous cancer, and the success of this study has given new hope to esophageal cancer patients in China.
Photo Source: Hengrui Pharmaceuticals SHR-1210-III-307 Research SHR-1210-III-307 Study is a randomized, double-blind, Phase 3 controlled clinical study designed to evaluate injections The effectiveness and safety of the first-line treatment of advanced or metastasis squamous non-small cell lung cancer with Karelli bead monoantigen or placebo, with Professor Zhou Caixuan of Shanghai Lung Hospital affiliated with Tongji University as the lead researcher, with the participation of 54 centers nationwide.
main research endpoint is PFS evaluated by the Blind Independent Center Review Committee based on the RECIST v1.1 standard.
end points include total lifetime, PFS evaluated by researchers, objective mitigation rate and safety.
A total of 390 subjects in this study were admitted to the 1:1 randomized group, receiving carelli's monoantigen or placebo combined with yew alcohol and carabin, 1 time every 3 weeks, after completing 4 or 6 cycles of combined therapy, entered the carelli's monoantigen or placebo maintenance treatment until the disease progressed, toxicity was not acceptable, or other conditions required to terminate treatment.
the disease in the control group can be conditioned cross-over to the Carelli pearl monodring treatment.
results showed that carelli-pearl monotherapy was used for first-line treatment in patients with advanced or metastasis squamous non-small cell lung cancer, which significantly prolonged the patient's progression-free survival.
: The phase III clinical study of Henrui Pharmaceutical Karelli Zhu single-line treatment of advanced esophageal cancer reached the main research endpoint. Retrieved Dec 16, 2020, from s2, Henri Henri Pharmaceuticals Karelli Pearl single anti-treatment advanced/metastasis squamous non-small cell lung cancer Phase III clinical studies reached the main research endpoint. Retrieved Dec 16, 2020, from Source: Medical Mission Hills