Table 1. Demographic Characteristics.
Characteristic | No. (%) | ||
---|---|---|---|
Savolitinib, 600 mg (n = 33) | Sunitinib, 50 mg (n = 27) | Total (n = 60) | |
Age, median (range), y | 60 (23-78) | 65 (31-77) | 62 (23-78) |
Sex | |||
Male | 29 (88) | 17 (63) | 46 (77) |
Female | 4 (12) | 10 (37) | 14 (23) |
Race | |||
White | 29 (88) | 23 (85) | 52 (87) |
Black | 1 (3) | 1 (4) | 2 (3) |
Asian | 2 (6) | 3 (11) | 5 (8) |
Other | 1 (3) | 0 | 1 (2) |
Countrya | |||
France | 1 (3) | 0 | 1 (2) |
Italy | 2 (6) | 3 (11) | 5 (8) |
Russia | 7 (21) | 9 (33) | 16 (27) |
Ukraine | 12 (36) | 5 (19) | 17 (28) |
South Korea | 2 (6) | 3 (11) | 5 (8) |
United States | 3 (9) | 0 | 3 (5) |
Brazil | 6 (18) | 7 (26) | 13 (22) |
IMDC risk group | |||
Poor | 4 (12) | 3 (11) | 7 (12) |
Intermediate | 22 (67) | 17 (63) | 39 (65) |
Favorable | 7 (21) | 7 (26) | 14 (23) |
Line of therapy | |||
1st line | 28 (85) | 25 (93) | 53 (88) |
≥2nd line with prior VEGF-TKI | 3 (9) | 0 | 3 (5) |
≥2nd line without prior VEGF-TKI | 2 (6) | 2 (7) | 4 (7) |
Histology subtype | |||
Type 1 | 10 (30) | 7 (26) | 17 (28) |
Type 2 | 11 (33) | 10 (37) | 21 (35) |
Unspecified | 10 (30) | 10 (37) | 20 (33) |
Missing | 2 (6) | 0 | 2 (3) |
Karnofsky performance status | |||
100% | 11 (33) | 4 (15) | 15 (25) |
90% | 15 (45) | 16 (59) | 31 (52) |
80% | 7 (21) | 7 (26) | 14 (23) |
SAVOIR CTA-specific MET-driven (BICR)b | |||
MET amplification | 1 (3) | 1 (4) | 2 (3) |
HGF amplification | 1 (3) | 0 | 1 (2) |
MET variation | 2 (6) | 3 (11) | 5 (8.3) |
Chromosome 7 gain | 30 (91) | 26 (96) | 56 (93) |
Abbreviations: BICR, blinded independent central review; CTA, clinical trial assay; HGF, hepatocyte growth factor; IMDC, Independent Data Monitoring Committee; VEGF-TKI, vascular endothelial growth factor receptor tyrosine kinase inhibitor.
Patients were enrolled in 57 study centers, and of these, 32 study centers had patients randomized.
Patients can be counted in more than 1 subtype group for MET driven by SAVOIR CTA.