Table 1. PI3K inhibitors in CLL . Phase... | American Society of Hematology

Table 1.

PI3K inhibitors in CLL

	Phase 1: duvelisib monotherapy⁹	Phase 3 DUO: duvelisib vs ofatumomab¹⁰	Phase 3: idelalisib-rituximab vs rituximab¹¹
	n = 55 (R/R CLL)	n = 160 (duvelisib), n = 159 (ofatumumab)	n = 110 (idelalisib-rituximab), n = 110 (rituximab)
Median prior therapies (range)	4 (1-11)	2 (1-10) vs 2 (1-8)	3 (1-12) vs 3 (1-9)
Median years since diagnosis (range)	8.5 (0.7-20.9)	7.5 vs 6.7	8.6 vs 9.0
ORR, %	56.4	73.8 vs 45.3*	83.6 vs 15.5*
CR, %	1.8	0.6 vs 0.6	0 vs 0
PR, %	54.5	72.5 vs 44.7	83.6 vs 15.5*
SD, %	34.5	21.3 vs 39.6	11.8 vs 64.5
PFS, mo	15.7	13.3 vs 9.9	19.4 vs 6.5
Discontinued due to adverse events, %	36.4	35.0 vs 4	20 vs 10.9
Key grade ≥3 adverse events with frequency ≥10%	Neutropenia, anemia, thrombocytopenia, pneumonia, transaminitis	Neutropenia, anemia, diarrhea/colitis, pneumonia	Neutropenia, pneumonia

	Phase 1: duvelisib monotherapy⁹	Phase 3 DUO: duvelisib vs ofatumomab¹⁰	Phase 3: idelalisib-rituximab vs rituximab¹¹
	n = 55 (R/R CLL)	n = 160 (duvelisib), n = 159 (ofatumumab)	n = 110 (idelalisib-rituximab), n = 110 (rituximab)
Median prior therapies (range)	4 (1-11)	2 (1-10) vs 2 (1-8)	3 (1-12) vs 3 (1-9)
Median years since diagnosis (range)	8.5 (0.7-20.9)	7.5 vs 6.7	8.6 vs 9.0
ORR, %	56.4	73.8 vs 45.3*	83.6 vs 15.5*
CR, %	1.8	0.6 vs 0.6	0 vs 0
PR, %	54.5	72.5 vs 44.7	83.6 vs 15.5*
SD, %	34.5	21.3 vs 39.6	11.8 vs 64.5
PFS, mo	15.7	13.3 vs 9.9	19.4 vs 6.5
Discontinued due to adverse events, %	36.4	35.0 vs 4	20 vs 10.9
Key grade ≥3 adverse events with frequency ≥10%	Neutropenia, anemia, thrombocytopenia, pneumonia, transaminitis	Neutropenia, anemia, diarrhea/colitis, pneumonia	Neutropenia, pneumonia

CR, complete remission; NR, not reached; PR, partial response; SD, stable disease.

P < 0.0001