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Text|Pharmaceutical Mission Hills
On September 18, Cinda Bio announced that it will announce the results of two important interim analyses of Sintilimab in the form of an oral report at the European Clinical Oncology Conference (ESMO 2021) in 2021.
ORIENT-15: First-line treatment of esophageal squamous cell carcinoma
ORIENT-15: First-line treatment of esophageal squamous cell carcinomaThe ORIENT-15 study is a comparison of sintilimab combined with chemotherapy (cisplatin + paclitaxel/5-fluorouracil) and placebo combined with chemotherapy (cisplatin + paclitaxel/5-fluorouracil) for the first-line treatment of unresectable locally advanced and recurrent unresectable Or a randomized, double-blind, international multi-center, phase 3 study of patients with metastatic esophageal squamous cell carcinoma
The results showed that the mid-term analysis of ORIENT-15 reached all the research endpoints:
In the overall population, the sintilimab combined chemotherapy group significantly prolonged the median overall survival (mOS) compared with the placebo combined chemotherapy group.
In people with PD-L1 positive (CPS≥10), sintilimab combined with chemotherapy significantly prolonged the median overall survival compared with placebo combined with chemotherapy.
In the overall population, the median progression-free survival (mPFS) of the two groups was 7.
In the PD-L1 positive (CPS≥10) population, the mPFS of the two groups were 8.
At the same time, compared with the placebo combined chemotherapy group, the sintilimab combined chemotherapy group has no new safety signals, and the safety is within a controllable range
The principal investigator of the ORIENT-15 study, Professor Lin Shen, deputy dean of Peking University Cancer Hospital, said: "More than half of the new cases and deaths of esophageal cancer worldwide occur in China
Dr.
ORIENT-16: First-line treatment of adenocarcinoma of stomach or gastroesophageal junction
ORIENT-16: First-line treatment of adenocarcinoma of stomach or gastroesophageal junctionThe ORIENT-16 study is a comparison of Sintilimab or placebo, combined with chemotherapy (oxaliplatin + capecitabine) for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction glands A randomized, double-blind, multi-center, phase 3 study on the effectiveness and safety of cancer
The results showed that sintilimab combined with chemotherapy significantly reduced the risk of death in the population with CPS ≥ 5 (HR 0.
The principal investigator of the ORIENT-16 study, Xu Jianming, director of the Department of Digestive Oncology, the Fifth Medical Center of PLA General Hospital, said: "The ORIENT-16 study is the first in China to prove that PD-1 monoclonal antibody combined with chemotherapy as first-line treatment can significantly prolong the overall survival of patients with advanced gastric cancer.
Dr.
Reference materials:
[1] At the 2021 ESMO annual meeting, Innovent announced the results of the interim analysis of the Phase 3 clinical study (ORIENT-15) of sintilimab combined with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma.
