OBJECTIVES

A matching-adjusted indirect comparison was undertaken to compare the efficacy and safety of acalabrutinib (acala) vs. ibrutinib (ibr) in the treatment of relapsed/refractory mantle cell lymphoma (MCL).

METHODS

Individual patient data from 124 patients treated with acala in the phase 2 ACE-LY-004 trial were adjusted to match average baseline characteristics for data from a pooled analysis population of 370 patients (studies: PCYC-1104, n=111; SPARK, n=120; RAY, n=139) treated with ibr. Patient populations were matched on age, sex, race, Eastern Cooperative Oncology Group performance status, Simplified MCL International Prognosis Index score, tumor bulk, lactate dehydrogenase, extranodal disease, bone marrow involvement, and number of prior treatment regimens. Outcomes assessed included response rates (overall (ORR), complete (CR)), overall survival (OS), progression-free survival (PFS) and Grade 3-4 adverse events (AEs).

RESULTS

After matching, the acala effective sample size was 45; median follow-up time for both treatments was approximately 15 months for response rates and 26 vs 24 months (acala vs ibr) for PFS, OS and AEs. The ORR was statistically significantly higher with acala (73.9%) vs. ibr (64.6%) (p<0.05). The CR was statistically significantly higher with acala (33.8%) vs. ibr (18.9%) (p<0.01). Median OS was not reached for acala vs. 25.1 months for ibr (hazard ratio 0.76, p=0.27). Median PFS was 18.0 months for acala vs. 12.8 months for ibr (hazard ratio 0.84, p=0.27). Acala showed statistically significantly lower rates of Grade 3-4 atrial fibrillation (rate difference -4.6%, p<0.001) and thrombocytopenia (rate difference -7.1%, p<0.01), vs. ibr.

CONCLUSIONS

This indirect comparison suggests that acala results in improved ORR and CR, and is well tolerated, with significantly lower rates of atrial fibrillation and thrombocytopenia, vs. ibr.