OBJECTIVES: Patients with relapsed and refractory (R/R) LBCL after 2L+ of systemic therapy in Poland can be treated with innovative CAR-T therapies - axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel). Therapies are reimbursed since May 2022 in the Polish setting under the Drug Programme's limited eligibility criteria. The NHF has provided survival data for patients who have received CAR-T therapies.

The aim of this study is to establish differences in the efficacy of CAR-T therapies in Poland in patients with LBCL and compare them with available real-world evidence from other countries.

METHODS: The NHF report on CAR-T therapies was used to compare the efficacy in terms of overall survival. Outcomes were compared with key findings from a meta-analysis of RWE from the US and Europe.

Pseudo-individual patient data were generated from available data - NHF report and RWE using a direct digitisation and Guyot's algorithm.

RESULTS: Comparative analysis of axi-cel and tisa-cel in the Polish setting showed hazard ratios for OS of 0.81 (95% CI, 0.46 to 1.44) and HR of 0.80 (0.44 – 1.47), depending on the method of IPD generation. Both analyses show comparable survival for axi-cel and tisa-cel (p>0.05), but with the direction favouring axi-cel.

Whereas, RWE shows significant improvements in OS for axi-cel compared with tisa-cel.

A comparison of each therapy between the Polish and RWE data shows lower median survival (12.4 vs. 19.5 months for axi-cel and 9.43 vs. 11.7 for tisa-cel, respectively). OS is better in countries other than Poland (p>0.05).

CONCLUSIONS: The RWE shows that axi-cel is superior to tisa-cel in OS, while the Polish data suggest that there is an advantage in favour of axi-cel over tisa-cel (p>0.05). Lower median survival were reported in Poland compared to the RWE data.

Differences in patient characteristics or inclusion criteria may inform why the Polish data are not consistent with RWE outcomes.