O-15 Randomized, phase 3 study of second-line tislelizumab vs chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302) in the overall population and Europe/North America subgroup

Abstract

Background: The global Phase 3 study RATIONALE 302 (NCT03430843) evaluated the efficacy and safety of second-line tislelizumab, an anti-PD-1 antibody, in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). Here, we report data from the overall and Europe/North America (EU/NA) populations. Conclusions:The final safety and efficacy results of the HEPANOVA trial are currently under final analyses. Our hypothesis is that treatment with TTFields as a novel modality for HCC will be efficacious and safe in treatment of advanced HCC. Clinical trial identification: NCT03606590.Legal entity responsible for the study: Novocure.

PD-1 inhibitors versus chemotherapy as second-line treatment for advanced esophageal squamous cell carcinoma: a meta-analysis

“…By following the designed selection algorithm, 534 published or unpublished documents were retrieved, from which 151 were concealed due to duplication and 324 were disregarded just by reviewing the title and abstract. After full-text review of the remaining 59 pieces of literature, five RCTs [ 15 – 19 ] were selected for further analysis (Fig. 1 ).…”

“…A total of 1970 trial participants from the five RCTs were included in this study, of which 987 received anti-PD-1 agent as a monotherapy for ESCC, while the other 983 received chemotherapy. Furthermore, three clinical trials were published from 2019 to 2020 [ 15 – 17 ], one of the five articles was an abstract presented at the ESMO Virtual Congress 2020 [ 18 ], and the remaining one was an abstract presented at the 2021 ASCO Virtual Annual Meeting [ 19 ]. Among the five clinical studies, three [ 15 , 16 , 19 ] were international multicenter phase III clinical studies and the other two [ 17 , 18 ] were multicenter clinical studies from China.…”

“…Furthermore, three clinical trials were published from 2019 to 2020 [ 15 – 17 ], one of the five articles was an abstract presented at the ESMO Virtual Congress 2020 [ 18 ], and the remaining one was an abstract presented at the 2021 ASCO Virtual Annual Meeting [ 19 ]. Among the five clinical studies, three [ 15 , 16 , 19 ] were international multicenter phase III clinical studies and the other two [ 17 , 18 ] were multicenter clinical studies from China. The immunotherapy agent was studied in each RCT as follows: pembrolizumab in KEYNOTE-181, nivolumab in ATTRACTION-3, camrelizumab in ESCORT, sintilimab in ORIENT-2 and tislelizumab in RATIONALE 302.…”

“…In three RCTs [ 15 – 17 ], randomized treatment allocation sequences were generated with an adequate method of allocation concealment. In the remaining two RCTs [ 18 , 19 ], the information regarding approaches to randomization and allocation concealment could not be determined. All five RCTs were considered to be acceptable risk of bias (Table 3 ).…”

“…OS data were available from all five studies [ 15 – 19 ], including 987 patients in the PD-1 inhibitor group and 983 patients in the chemotherapy group. The results showed that PD-1 inhibitors had a significantly reduced risk of death compared with chemotherapy (HR: 0.73, 95% CI: 0.66–0.81, P < 0.001; heterogeneity: I 2 = 0.0%, P = 0.925) (Fig.…”