Domestic PD-1 immunotherapy! Tislelizumab (tirelizumab) combined with chemotherapy has a strong therapeutic effect on gastric / esophageal cancer!

November 26, 2019 / bioun / -- beigene recently announced the phase II clinical research data of anti-PD-1 antibody tislilizumab (tirelizumab) combined with chemotherapy for gastric / gastroesophageal junction (g / GEJ) adenocarcinoma or esophageal squamous cell carcinoma (ESCC) at the Asia Conference of European Society of Oncology (ESMO) held in Singapore In this study, combination therapy showed long-lasting efficacy and was generally well tolerated in patients with g / GEJ adenocarcinoma or ESCC This is an open label, multicenter phase II trial (nct03469557) under development in China, which is composed of the g / GEJ adenocarcinoma patient cohort and ESCC patient cohort, and is evaluating tislilizumab combined with standard chemotherapy as a potential first-line treatment As of March 31, 2019, 30 patients were enrolled in the trial, including 15 patients with g / GEJ adenocarcinoma and 15 patients with ESCC Patients with g / GEJ adenocarcinoma received 200mg of tislilizumab and oxaliplatin on the first day of each cycle (21 days / cycle), capecitabine on the first to 15th days (twice a day); ESCC patients received 200mg of tislilizumab and cisplatin on the first day of each cycle (21 days / cycle), and fluorouracil (5-FU) on the first to 5th days At the end of the data, 8 patients were still receiving treatment, including 4 patients with g / GEJ adenocarcinoma and 4 patients with ESCC The results showed that as of the end of the data period: (1) 7 patients with g / GEJ adenocarcinoma (46.7%) achieved partial remission (PR), and the objective remission rate (ORR) (the sum of Cr and PR) was 46.7%; in the ESCC patient cohort, 7 patients (46.7%) achieved confirmed PR, and the orr of the cohort was 46.7%; the median remission duration (DOR) of the g / GEJ adenocarcinoma cohort was not mature; ESCC The median dor in the queue is estimated to be 12.8 months (2) Median progression free survival (PFS) was 6.1 months in the g / GEJ adenocarcinoma cohort and 10.4 months in the ESCC cohort (3) Despite a long median follow-up of the g / GEJ adenocarcinoma cohort (15.4 months) and ESCC cohort (13.0 months), the median overall survival time (OS) has not been achieved; in the g / GEJ adenocarcinoma cohort, the 6-month OS rate was 85%, and the 12-month OS rate was 62%; in the ESCC cohort, the 6-month OS rate was 71%, and the 12-month OS rate was 50% (4) In g / GEJ adenocarcinoma patients and ESCC patients, tisleizumab combined with standard first-line chemotherapy has good tolerance The reported adverse events (AE) were consistent with the tolerance profile of known PD-1 inhibitors combined with chemotherapy All patients had treatment emergent adverse events (teaes), and most of them were mild to moderate "In this trial, the combination of tislilizumab and chemotherapy showed a long-lasting effect, and it was generally well tolerated in patients with g / GEJ adenocarcinoma or ESCC," commented Ben Yong, MD, chief medical officer of tumor immunology of Baiji Shenzhou Gastric and esophageal cancer is one of the most common types of cancer in the world, representing a highly unmet need, especially in China We are very pleased to continue the late development of tislilizumab in these and other highly prevalent cancers in Asia " Tislilizumab (bgb-a317) is a humanized IgG4 anti-PD-1 monoclonal antibody After special design, it can minimize the binding with FC γ r on macrophages, thus eliminating antibody dependent phagocytosis (ADCP effect), which may be the potential mechanism of reducing T-cell depletion and anti-PD-1 treatment resistance Tislilizumab is the first drug of choice in Baiji Shenzhou immunotumor biology project It is currently being developed as a single drug therapy in combination with other therapies to treat a wide range of solid tumors and blood tumors At present, the new drug application (NDA) of tislilizumab in patients with recurrent or refractory classical Hodgkin's lymphoma (R / R CHL) and patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received treatment has been accepted by the National Drug Administration (nmpa) of China, and given priority to review Indications for treatment of R / R CHL are expected to be approved by the end of this year, and indications for UC are expected to be approved by 2020 Original source: Beijing announcements clinical data on tislilizumab presented at European Society for Medical Oncology (ESMO) Asia 2019 progress