Transportability of tislelizumab trial outcomes from RATIONALE-315, RATIONALE-303, and RATIONALE-312 to the European population in early-stage non-small cell lung cancer (NSCLC), advanced NSCLC and extensive-stage small cell lung cancer (ES-SCLC).

内容摘要

Tislelizumab was evaluated in randomized controlled trials (RCTs) for non-small cell lung cancer (NSCLC) (RATIONALE-315, RATIONALE-303) and extensive-stage small cell lung cancer (ES-SCLC) (RATIONALE-312), primarily in Asian populations. We assessed the transportability of clinical findings from these RCTs to European patients. Targeted literature reviews (TLRs) identified real world-evidence (RWE), RCTs, and treatment effect modifiers in perioperative NSCLC, second-line or later (2L+) NSCLC, and first-line (1L) ES-SCLC. Relevant RWE studies were selected to define the target European-like populations. Outcome regression models used RATIONALE individual patient data to predict relative treatment effect of tislelizumab vs. comparators in European populations. Event-free survival (HR 0.56), major pathological response (OR 7.49) and pathological complete response (OR 11.54) from RATIONALE-315 were similar to those predicted for the base case European target perioperative NSCLC population (EFS HR 0.57; MPR OR 3.39; PCR OR 8.95). Predicted overall survival and progression-free survival for 2L+ NSCLC and for 1L ES-SCLC were similar to RATIONALE-303 and RATIONALE-312, respectively. The efficacy of tislelizumab observed in the RATIONALE trials explored in this analysis is transportable, subject to the specified assumptions, to European patients in the setting of perioperative NSCLC, 2L+ NSCLC, and 1L ES-SCLC, consistently favoring tislelizumab over control. Tislelizumab is a treatment that helps the body’s immune system find and attack cancer cells. It has been tested in three large lung cancer studies (RATIONALE-315, RATIONALE-303, and RATIONALE-312). Most people in these studies were treated in Asia. We wanted to see if the results are relevant for patients treated in Europe. We looked at published reports that described European patients with: (1) non-small cell lung cancer (NSCLC) treated around surgery, (2) advanced NSCLC treated after previous chemotherapy, and (3) extensive-stage small cell lung cancer (ES-SCLC) treated first-line. Next, we used statistics to make the trial groups more similar to European patients. We adjusted for differences such as age, sex, cancer type, smoking history, and performance status, where available. After adjustment, the predicted benefits of tislelizumab in European-like populations were similar to those seen in the original studies. In all three settings, results still favored tislelizumab compared with the control treatments. Some factors could not be fully adjusted because they were not included in some studies. Overall, these results suggest the trial results are applicable to Europeans.