Hengrui Pharmaceutical PD-1 antibody two first-line therapeutic adaptation phase 3 clinical up to the main research...

On December 16th Henri Pharmaceuticals announced that the innovative drug, Carelli pearl monoantigen (Erika), had reached the end of two Phase 3 clinical studies: one for first-line treatment of advanced esophageal cancer with combined yew alcohol and cisplatin, and the other for first-line treatment of advanced or metastatic squamous non-small cell lung cancer patients with combined chemotherapy.
Hengrui Pharmaceuticals said in a press release that it will submit a pre-market communication application to the Drug Review Center (CDE) of the State Drug Administration of China in the near future.
Karelli pearl monoantigen is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceuticals and with 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 the first-line treatment of advanced esophageal cancer with carellidate monoantigen and cisplatin, conducted by Professor Ruihua Xu 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 injected with carelli's monoantigenated combined yew alcohol and cisplatin or placebo combined with cisplatin and cisplatin, respectively, in a randomized group of 1:1, and the combined treatment did not exceed 6 cycles, followed by injection with carellidate monoantigen or placebo maintenance treatment until the disease progressed, toxicity was not acceptable or other conditions required to be terminated.
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 yew alcohol and cisplatin first-line treatment of advanced esophageal squamous cancer, and the success of this study has given new hope to patients with esophageal cancer 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.
study 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 a random group of 1:1, receiving carelli's monoantigen or placebo combined with yew alcohol and carabin, given once every 3 weeks, and after completing 4 or 6 cycles of combined therapy, entered karelli's monoantigen or placebo maintenance therapy until the disease progressed, toxicity was not acceptable, or other conditions required termination of treatment.
the disease in the control group can be conditioned cross-over to the Carelli pearl monodring treatment.
results showed that kariliju 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 medicine Karelli pearl single-line treatment of advanced esophageal cancer reached the end of the main study. Retrieved Dec 16,2020, from Hengrui Henri Pharmaceuticals Karelli Pearl single anti-treatment late/metastasis squamous non-small cell lung cancer Phase III clinical study reached the main research endpoint. Retrieved Dec 16, 2020, from Source: Medical Mission Hills