New developments in the management of chronic lymphocytic leukemia: role of ofatumumab

Figures & data

Table 1 Clinical studies of single-agent ofatumumab in relapsed/refractory CLL

Study	Phase	Treatment	n		ORR (%)	CR (%)	Median PFS	Median OS
Coiffier et al^Citation1	I/II	Ofa	27 (cohort C)		48	0	106 days	ND
Wierda et al^Citation3	II	Ofa in FA-ref	138	59	58	0	5.7 months	13.7 months
		Ofa in BF-ref		79	47	1	5.9 months	15.4 months
Moreno et al^Citation22	IV	Observational study	103		22	3	5 months	11 months
Byrd et al^Citation23	III	Ibrutinib vs Ofa	391		43 vs 4	0 vs 0	Ibrutinib NR (88% at 6 months) vs 8.1 months’ Ofa	Both groups NR; at 12 months, 90% vs 81%

Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; CR, complete response; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; FA-ref, fludarabine- and alemtuzumab-refractory; BF-ref, fludarabine-refractory (with bulky [>5 cm] lymphadenopathy); ND, no data; NR, not reached.

Table 2 Clinical studies of ofatumumab combination therapy in relapsed/refractory CLL

Study	Phase	Treatment	n	ORR (%)	CR (%)	Median PFS	Median OS
Cortelezzi et al^Citation24	II	Ofa and Benda	47	72	17	23.6 months	83.6% at 24.2 months
Offner et al^Citation25	II	Ofa and Benda in untreated and relapsed	97			NR	NR
			44 un	95 un	43 un
			53 rel	74 rel	11 rel
Doubek et al^Citation26	II	Ofa and dexamethasone	33	67	15	10 months	34 months
				Del (17p) 63	Del (17p) 25
Costa et al^Citation29	II	Sequential treatment with Ofa and lenalidomide	21	47.6	ND	ND	21.5 months
Jaglowski et al^Citation30	IB/II	Ofa and ibrutinib	71	83.3	1.5	12 months	NR

Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; CR, complete response; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; Benda, bendamustine; ND, no data; NR, not reached; Del, deleted; un, untreated; rel, relapsed.

Table 3 Clinical studies with ofatumumab in untreated CLL patients

Study	Phase	Treatment	n	ORR (%)	CR (%)	Median PFS	Median OS
Wierda et al^Citation33	II	O-FC	61			NR	NR
		Ofa at different schedule in group A	31 pts group A	77	32
		Group B	30 pts group B	73	50
Hillmen et al^Citation37	III	Ofa plus Clb vs Clb monotherapy	447				NR at 29 months
			221	82	12	22.4 months
			226	69	1	13.1 months
Shanafelt et al^Citation38	II	PCO	48	96	46	NR	NR

Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; CR, complete response; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; O-FC, Ofa + fludarabine–cyclophosphamide; pts, patients; Clb, chlorambucil; PCO, pentostatin, cyclophosphamide, and ofatumumab; NR, not reached.

Table 4 Ongoing studies with ofatumumab single agent or in combination in CLL

Study	Phase	Treatment	n	ORR (%)	Median PFS, months	Median OS, months
van Oers et al^Citation40	III	Maintenance Ofa vs observation in relapsed patients after salvage therapy	474	Time to next therapy 38 vs 27.4 months	28.6 vs 15.2	No differences in OS at the interim analysis
Robak et al^Citation41	III	Ofa plus FC vs FC alone in relapsed patients	365
			183 vs 182	84 vs 68	28.9 vs 18.8	56.4 vs 45.8
Jones et al^Citation42	III	Ofa plus Idela vs Ofa in relapsed patients	261
			174 vs 87	75 vs 18	16.3 vs 8.0	20.9 vs 19.4

Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; FC, fludarabine + cyclophosphamide; Idela, idelalisib.

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