Third-line therapy for chronic myeloid leukemia: current status and future directions

Table 1 Response rates of 1L and 2L TKI therapies^a

Study	Number of patients, n	Arms	Response	Response rate, n (%)	Patients remaining on study at data cutoff, n (%)
1L
Hochhaus A, et al. Leukemia. 2016 [16]	283	Imatinib 400 mg QD	MMR by 5 y MR⁴ MR^4.5	171 (60.4) 118 (41.7) 89 (31.4)	141 (49.8)^b
	282	Nilotinib 300 mg BID	MMR MR⁴ MR^4.5	217 (77.0) 185 (65.6) 151 (53.5)	169 (59.9)
	281	Nilotinib 400 mg BID	MMR MR⁴ MR^4.5	217 (77.2) 177 (63.0) 147 (52.3)	174 (61.9)
Cortes J, et al. J Clin Oncol. 2016 [17]	260	Imatinib 400 mg QD	MMR by 5 y MR^4.5	(64) (33)	162 (63)
Cortes J, et al. J Clin Oncol. 2016 [17]	259	Dasatinib 100 mg QD	MMR MR^4.5	(76) (42)	158 (61)
Cortes J, et al. J Clin Oncol. 2018 [14]	241^c	Imatinib 400 mg QD	MMR at 2 y MR⁴	(50.7) (25.7)
Cortes J, et al. J Clin Oncol. 2018 [14]	246	Bosutinib 400 mg QD	MR^4.5 MMR MR⁴ MR^4.5	(10.8) (61.2) (32.8) (13.1)
2L
Kantarjian H, et al. Blood. 2011 [24]	321^d	Nilotinib 400 mg BID	MCyR by 2 y MMR	(59)^e,f 82 (28)^g	124 (39)
Shah N, et al. Haematologica. 2010 [25]^h	167	Dasatinib mg 140 QD	MCyR by 2 y CCyR MMRⁱ	105 (63) 84 (50) 55 (38)
	167	Dasatinib 100 mg QD	MCyR CCyR MMR	106 (63) 83 (50) 57 (37)
	168	Dasatinib 70 mg BID	MCyR CCyR MMR	103 (61) 90 (54) 56 (38)
	168	Dasatinib 50 mg QD	MCyR CCyR MMR	103 (61) 84 (50) 59 (38)
Gambacorti-Passerini C, et al. Am J Hematol. 2014 [131]	200	Bosutinib (imatinib resistant)	MCyR^j CCyR^j MMR^k	108 (58) 85 (46) 45 (34)	92 (46)
Gambacorti-Passerini C, et al. Am J Hematol. 2014 [131]	88	Bosutinib (imatinib intolerant)	MCyR^l CCyR^l MMR^m	49 (61) 43 (54) 24 (35)	37 (42)

1L first line, 2L second line, BID twice a day, CCyR complete cytogenetic response, MCyR major cytogenetic response, MMR major molecular response, MR⁴ 4.0-log molecular response (BCR-ABL1^IS ≤ 0.01%), MR^4.5 4.5-log molecular response (BCR-ABL1^IS ≤ 0.0032%), QD once a day, TKI tyrosine kinase inhibitor
^aThese are selected studies focusing on pivotal trials
^bPatients remaining on core study treatment at 5 years
^c268 patients were randomized to each arm; however, 54 failed screening; 3 patients randomly assigned to imatinib arm were not treated
^dPatients were resistant or intolerant to imatinib
^e45% if measured only by metaphase analysis and excluding fluorescence in situ hybridization analysis and also excluding MCyR responders who had an MCyR at baseline or who had a missing cytogenetic analysis at baseline
^f56% for imatinib-resistant patients and 66% for imatinib-intolerant patients
^gMolecular response was assessed in 294 of the 321 patients
^hPatients remaining on study at data cutoff were not included in the publication
ⁱ600 patients were assessed for molecular response
^j186 evaluable patients
^k132 evaluable patients
^l80 evaluable patients
^m68 evaluable patients

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