Safety, efficacy and pharmacokinetics of BPI-9016M in c-MET overexpression or MET exon 14 skipping mutation patients with locally advanced or metastatic non-small-cell lung cancer: a phase Ib study

Table 2 ≥ 10% TRAEs of BPI-9016M in SS

TRAEs	Part A						Part B		Total (n = 38) n (%)
	300 mg QD (n = 12) n (%)		450 mg QD (n = 12) n (%)		600 mg QD (n = 10) n (%)		400 mg BID (n = 4) n (%)		Total (n = 38) n (%)
	Any grade	Grade 3–4	Any grade	Grade 3–4	Any grade	Grade 3–4	Any grade	Grade 3–4	Any grade	Grade 3–4
Elevated ALT	3 (25.0)	0	5 (41.7)	0	3 (30.0)	0	3 (75.0)	0	14 (36.8)	0
Elevated AST	2 (16.7)	0	5 (41.7)	0	1 (10.0)	0	3 (75.0)	0	11 (28.9)	0
Dysgeusia	1 (8.3)	0	3 (25.0)	0	5 (50.0)	1 (10.0)	0	0	9 (23.7)	1 (2.6)
PPE	1 (8.3)	0	3 (25.0)	1 (8.3)	1 (10.0)	0	4 (100.0)	3 (75.0)	9 (23.7)	4 (10.5)
Constipation	2 (16.7)	0	5 (41.7)	0	1 (10.0)	0	0	0	8 (21.1)	0
Elevated blood creatinine	3 (25.0)	0	2 (16.7)	0	1 (10.0)	0	1 (25.0)	0	7 (18.4)	0
Decreased Ccr	2 (16.7)	0	2 (16.7)	0	2 (20.0)	0	0	0	6 (15.8)	0
Asthenia	0	0	2 (16.7)	0	3 (30.0)	1 (10.0)	0	0	5 (13.2)	1 (2.6)
Decreased appetite	2 (16.7)	0	2 (16.7)	0	1 (10.0)	1 (10.0)	0	0	5 (13.2)	1 (2.6)
Proteinuria	0	0	3 (25.0)	1 (8.3)	1 (10.0)	0	0	0	4 (10.5)	1 (2.6)
Hypertension	1 (8.3)	0	0	0	2 (20.0)	1 (10.0)	1 (25.0)	0	4 (10.5)	1 (2.6)

Data are n (%). One patient in the 450 mg QD cohort suffered adverse event of pulmonary infection leading to death, which was deemed unrelated to BPI-9016M
TRAEs treatment-related adverse events, SS safety set, ALT alanine aminotransferase, AST aspartate aminotransferase, PPE palmar-plantar erythrodysesthesia, Ccr creatinine clearance, QD quaque die, BID bis in die

ISSN: 1471-2407