Table 1. Results of published clinical... | American Society of Hematology

Table 1.

Results of published clinical trials of BTK inhibitors in patients with relapsed MCL

Parameter	Ibrutinib^25,34	Acalabrutinib^43,44
No. of patients	111	124
Phase of study	Single-arm phase 2	Single-arm phase 2
Median age, y	68	68
MIPI score: low/intermediate/high, %	14/38/49	39/44/17
Median no. of prior therapies	3	2
Prior rituximab, %	89	95
Prior stem cell transplant, %	11	18
Prior proteasome inhibitor, %	43	19
Prior lenalidomide, %	24	7
Dose	560 mg postoperatively daily indefinitely	100 mg postoperatively twice daily indefinitely
ORR, %	68	81
Complete remission, %	21	40
Median duration of response, mo	17.5	25.7
Median PFS, mo	13.9	19.5
Median OS, mo	Median not reached; 47% OS at 24 mo	Median not reached; 72% OS at 24 mo
Stopped drug due to adverse events, %	7	6
New atrial fibrillation, %	11	0
Bleeding	5 with grade 3; no grade 4-5	22% petechiae/purpura (all grades 1-2) 3 grade 3 (GI bleed; hematuria, hematoma on each)
Grade 3/4 neutropenia, %	6/10	5/6
Grade 2/3 pneumonia, %	6	1/5

Parameter	Ibrutinib^25,34	Acalabrutinib^43,44
No. of patients	111	124
Phase of study	Single-arm phase 2	Single-arm phase 2
Median age, y	68	68
MIPI score: low/intermediate/high, %	14/38/49	39/44/17
Median no. of prior therapies	3	2
Prior rituximab, %	89	95
Prior stem cell transplant, %	11	18
Prior proteasome inhibitor, %	43	19
Prior lenalidomide, %	24	7
Dose	560 mg postoperatively daily indefinitely	100 mg postoperatively twice daily indefinitely
ORR, %	68	81
Complete remission, %	21	40
Median duration of response, mo	17.5	25.7
Median PFS, mo	13.9	19.5
Median OS, mo	Median not reached; 47% OS at 24 mo	Median not reached; 72% OS at 24 mo
Stopped drug due to adverse events, %	7	6
New atrial fibrillation, %	11	0
Bleeding	5 with grade 3; no grade 4-5	22% petechiae/purpura (all grades 1-2) 3 grade 3 (GI bleed; hematuria, hematoma on each)
Grade 3/4 neutropenia, %	6/10	5/6
Grade 2/3 pneumonia, %	6	1/5

GI, gastrointestinal.