Immunotherapy for esophageal squamous cell carcinoma (ESCC)! Compared with chemotherapy, the second-line treatment of bosimer opdivo significantly prolonged the total survival time!

October 8, 2019 / BIOON / -- Bristol Myers Squibb (BMS) recently announced the results of the phase III clinical study on the treatment of esophageal squamous cell carcinoma (ESCC) by PD-1 tumor immunotherapy opdivo (nivolumab, nevulizumab) attraction-3 (ono-4538-24 / ca209-473; nct02569242) The study is a multicenter, randomized, open label, global study conducted in patients with unresectable advanced or recurrent ESCC who are refractory or intolerant to combination therapy of first-line fluoropyrimidine and platinum drugs, and evaluated the efficacy and safety of opdivo compared with chemotherapy (docetaxel or paclitaxel) Patients were enrolled mainly in Asia, and up to 96% of the patients in the two treatment groups came from Asia In the study, patients were treated until the disease worsened or the toxicity was unacceptable The primary end points of the study were overall survival (OS), and secondary end points included investigator assessed overall remission rate (ORR), progression free survival (PFS), disease control rate (DCR), duration of remission (DOR), and safety The study was sponsored by Ono Pharma, an opdivo partner of Bristol Myers Squibb The results showed that the study reached the primary end point of OS: compared with the chemotherapy group, the opdivo treatment group showed a statistically significant improvement in OS, a 23% reduction in risk of death (HR = 0.77, 95% CI: 0.62-0.96, P = 0.019), a 2.5-month extension of median OS (10.9 months [95% CI: 9.2-13.3] vs 8.4 months [95% CI: 7.2-9.9]) The 12-month and 18 month survival rates (OS) were 47% (95% CI: 40-54) and 31% (95% CI: 24-37) in the opdivo group, 34% (95% CI: 28-41) and 21% (95% CI: 15-27) in the chemotherapy group, respectively Regardless of the level of PD-L1 expression, the survival benefit of opdivo was observed An exploratory analysis of the results reported by the patients showed that compared with chemotherapy, the quality of life of the patients treated with opdivo had a significant overall improvement For orr, 19% (95% CI: 14-26) and 22% (95% CI: 15-29) were in the opdivo group and the chemotherapy group, respectively However, this study showed that opdivo significantly prolonged the median duration of remission (DOR: 6.9 months [95% CI: 5.4-11.1] vs 3.9 months [95% CI: 2.8-4.2]) compared to chemotherapy At the end of the data period, 7 patients in the opdivo treatment group remained in remission, and 2 patients in the chemotherapy group In terms of PFS, there was no significant difference between the treatment group and the chemotherapy group (HR = 1.08 [95% CI: 0.87-1.34]) In this study, the safety of opdivo was consistent with previous studies in ESCC and other solid tumors Compared with chemotherapy, the incidence of treatment-related adverse events (RAE) in opdivo patients was 60% and 95% respectively The incidence of three or four levels of trea was lower in the opdivo group than in the chemotherapy group (18% vs 63%), and the proportion of patients who experienced trea leading to drug withdrawal was the same in both groups (9%) Dr byoung Chul CHO, Professor of the cancer center of the medical school of the University of Yanshi, said: "the significant survival benefits observed in this trial, as well as the good safety and patient reporting results indicate that opdivo may provide an important second-line treatment scheme for patients with advanced esophageal squamous cell carcinoma, and provide the possibility of prolonging the survival period and improving the quality of life during the treatment process ”Ian M Waxman, head of gastrointestinal cancer development at Bristol Myers Squibb, said: "these data are very promising and important results for patients with advanced esophageal squamous cell carcinoma who usually have a poor prognosis, because opdivo improves survival without relying on PD-L1 status We are encouraged by the important progress made in this type of tumor and look forward to broadening our research on gastrointestinal tumors " Esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of cancer death The five-year relative survival rate for patients diagnosed with metastatic disease was 8% or less The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, accounting for 90% and 10% of all esophageal cancers It is estimated that 572000 new cases are confirmed each year, and about 500000 people die of esophageal cancer Most of the cases are advanced diseases at the time of diagnosis, which should affect the patients' daily life, including eating ability Asia has the highest incidence of esophageal cancer, with 444000 confirmed cases every year, accounting for 80% of the world's cases of esophageal cancer It is worth mentioning that at the end of July this year, keytruda (coreda, common name: pembrolizumab, pabolizumab) was approved by the US FDA to treat patients with PD-L1 positive esophageal squamous cell carcinoma (ESCC) Approved test methods identified patients with recurrent, locally advanced, or metastatic ESCC who expressed PD-L1 (with a positive score of [CPS] ≥ 10) and progressed after one or more systemic therapies Keytruda is the first anti-PD-1 therapy approved for patients with recurrent locally advanced or metastatic ESCC (tumor expression of PD-L1, CPS ≥ 10) The approval was based on data from two clinical studies keynote-181 (nct02564263) and keynote-180 (nct02559687) Data from the keynote-181 study showed that in ESCC patients with tumor expression of PD-L1 (CPS ≥ 10), keytruda treatment improved OS compared with chemotherapy (median OS: 10.3 months [95% CI: 7.0-13.5] vs 6.7 months [95% CI: 4.8-8.6]; HR = 0.64 [95% CI: 0.46-0.90]) Data from the keynote-180 study showed that in 35 ESCC patients with tumor expression of PD-L1 (CPS ≥ 10), Orr was 20% (95% CI: 8.0, 37.0) In 7 patients with remission, DOR ranged from 4.2 months to 25.1 + months, 71% patients (5 cases) dor ≥ 6 months, 57% patients (3 cases) dor ≥ 12 months Original source: opdivo (nivolumab) demonstrates statistically significant overall survival benefit versus chemotherapy in patients with advanced essential cancer