Pevonedistat in East Asian patients with acute myeloid leukemia or myelodysplastic syndromes: a phase 1/1b study to evaluate safety, pharmacokinetics and activity as a single agent and in combination with azacitidine

Table 1 Overall summary of TEAEs (safety population)

	Pevonedistat			Pevonedistat + azacitidine 75 mg/m²			Total
	25 mg/m² N = 3 n (%)	44 mg/m² N = 7 n (%)	Total N = 10 n (%)	10 mg/m² N = 3 n (%)	20 mg/m² N = 10 n (%)	Total N = 13 n (%)	N = 23 n (%)
Any TEAE	3 (100)	7 (100)	10 (100)	3 (100)	10 (100)	13 (100)	23 (100)
Grade ≥ 3^a	3 (100)	7 (100)	10 (100)	3 (100)	10 (100)	13 (100)	23 (100)
Grade ≥ 4^a	0	2 (28)	2 (20)	2 (66)	5 (50)	7 (53)	9 (39)
Any drug-related TEAE	3 (100)	3 (43)	6 (60)	3 (100)	8 (80)	11 (85)	17 (74)
Grade ≥ 3^a	2 (67)	2 (29)	4 (40)	3 (100)	7 (70)	10 (76)	14 (61)
SAE	2 (67)	7 (100)	9 (90)	2 (67)	4 (40)	6 (46)	15 (65)
Drug-related SAE	0	1 (14)	1 (10)	1 (33)	2 (20)	3 (23)	4 (17)
TEAEs resulting in study drug discontinuation	0	2 (29)	2 (20)	2 (67)	1 (10)	3 (23)	5 (22)
TEAEs resulting in discontinuation from the study	0	3 (43)	3 (30)	2 (67)	2 (20)	4 (31)	7 (30)
On-study deaths^b	0	1 (14)	1 (10)	1 (33)	1 (10)	2 (15)	3^c (13)

SAE, serious adverse event; TEAE, treatment-emergent adverse event
TEAE was defined as any adverse event that occurred after administration of the first dose of study treatment and up through 30 days after the last dose of study drug, any event that was considered drug related regardless of the start date of the event, or any event that was present at baseline but worsened in severity after baseline. Percentages are based on the total number of patients in safety population in each column. A patient counts once for each event
^aIndividual grades represent the maximum severity a patient experienced
^bOn-study deaths were defined as deaths that occurred between the first dose of study drug and 30 days after the last dose of study drug
^cAML, pneumonia and acute kidney injury (n = 1 each); no on-study deaths were attributed to study treatments

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