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Matching-adjusted Indirect Comparison (MAIC) of crizotinib with standard of care in progressed NSCLC ALK+ patients based on Real-World Evidence (RWE) and clinical trial data in the Czech Republic

Auhtors: Pásztor B., Losenický L., Mazan P., Duba J., Kolek M.
Objectives.
Non-small-cell-lung-carcinoma (NSCLC) markedly shortens and deteriorates life of patients. The aim of this analysis was to compare the relative effectiveness of crizotinib in progressed NSCLC ALK+ patients to Czech standard of care based on RWE and clinical trial data while adjusting for patients’ characteristic differences.
Methods.
Patient characteristics and outcomes data were taken from RWE (NSCLC Registry TULUNG and Registry of Highly Innovative Drug VILP) in the Czech Republic and the PROFILE 1007 clinical trial. Patient-level data were available for crizotinib RWE only. Differences in patients’ characteristics in the crizotinib and pemetrexed arms were thus adjusted by MAIC approach. Age, sex, ECOG, smoking status, stage and histology types were included in the matching analysis. After matching, median overall survival (OS) and progression free survival (PFS) were estimated.
Results.
There were 51 crizotinib patients in the Czech RWE arm receiving 2nd or later line crizotinib.  Median follow-up of crizotinib RWE patients was 11,5 months. After matching, the patients’ characteristics were comparable. Naïve comparison of PFS and OS resulted in medians 5,8 and 15,3 months for crizotinib from RWE, 3,1 and 9,5 months for pemetrexed from RWE and 4,2 and 22,8 for pemetrexed from PROFILE 1007. After matching, the median PFS and OS of crizotinib from RWE changed to 4,8 and 14,2 months when adjusted to pemetrexed RWE and 6,2 and 27,2 months when adjusted to pemetrexed PROFILE 1007 data. Crizotinib increased PFS by 54% and 47% and OS by 49% and 19% when compared to pemetrexed RWE and pemetrexed PROFILE 1007 data, respectively.
Conclusions
Treatment of progressed ALK+ NSCLC with crizotinib is associated with major prolongation of PFS and OS compared to pemetrexed in the Czech real-world setting after adjusting for the patients’ characteristic differences.