Abstract 163P
Background
In the RATIONALE-315 (NCT04379635) trial, neoadjuvant tislelizumab plus chemotherapy followed by adjuvant tislelizumab (TIS) resulted in a statistically significant improvement in efficacy versus neoadjuvant chemotherapy + placebo followed by adjuvant placebo (nCT + PBO), in patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC). RATIONALE-315 was conducted in China; this analysis evaluated the transportability of efficacy outcomes to the European population.
Methods
A protocol-driven targeted literature review (TLR) was conducted to identify literature reporting baseline characteristics of stage II-IIIA NSCLC patients in European real-world populations. All retrieved abstracts and full texts were screened according to predetermined criteria. The final studies selected were considered the most suitable to define the target European populations. Outcome regression analyses were conducted to estimate the transportability of treatment effects observed in RATIONALE-315 for event-free survival (EFS), major pathological response (MPR) and pathological complete response (pCR) to the European population.
Results
After screening 178 articles and 8 gray literature sources, 10 studies were included in the TLR. Two studies, which enrolled patients in the defined target populations, were deemed relevant for the statistical analyses. EFS for RATIONALE-315 (HR: 0.56 [0.40–0.79]) was comparable to the predicted results for the target European population 1 (HR: 0.57 [95% CI: 0.25–1.34]) and target population 2 (HR: 0.63 [0.35–1.13]). Similarly, MPR for RATIONALE-315 indicated a substantial benefit of TIS versus nCT + PBO (OR: 7.49 [4.75–11.82]), and this was aligned with the predicted MPR results (population 1 OR: 3.39 [1.07–11.52]; population 2 OR: 10 [4.19–25.71]). Similar results were observed for pCR (RATIONALE-315 OR: 11.54 [6.18–21.54], versus predicted ORs for European target population 1: 8.95 [1.92–58.88] and population 2: 12.41 [4.18–46.85]).
Conclusions
These analyses demonstrated that the treatment effects of TIS versus nCT + PBO observed in the RATIONALE-315 trial are applicable to European patients with resectable NSCLC.
Clinical trial identification
NCT04379635.
Editorial acknowledgement
This study was sponsored by BeiGene, Ltd. Medical writing support was provided by Simone Rivolo, PhD, Caroline von Wilamowitz-Moellendorff, PhD, and Venediktos Kapetanakis, PhD, of Evidera, a business unit of PPD, part of Thermo Fisher Scientific, and was funded by BeiGene. Editorial support was provided by Envision Pharma Inc., and was funded by BeiGene.
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
F. Passiglia: Financial Interests, Personal, Advisory Role, consulting/advisory fee: Amgen, AstraZeneca, BeiGene, Janssen, Merck Sharp Dohme, Sanofi, Thermo Fisher Scientifics. E. Priedane, S. Mardiguian, A. Mendoza, S. Leaw, Y. Wang, X. Lin: Financial Interests, Personal, Full or part-time Employment: BeiGene, Ltd. M. Farraia, A. Pandey, P. Shukla, C. von Wilamowitz-Moellendorff, S. Rivolo, V. Kapetanakis: Financial Interests, Personal, Full or part-time Employment: Evidera, a business unit of PPD, part of Thermo Fisher Scientific.