Table 1.
Dose-escalation phase (n = 66) | Expansion phase: oleclumab 40 mg/kg + durvalumab 10 mg/kg (n = 126) | ||||
---|---|---|---|---|---|
Single-agent oleclumab 5–40 mg/kg (n = 42) | Oleclumab 5–40 mg/kg + durvalumab 10 mg/kg (n = 24) | MSS-CRC (n = 42) | PDAC (n = 42) | EGFRm NSCLC (n = 42) | |
Age, median (range), years | 59.5 (36–81) | 55 (32–71) | 53 (25–80) | 63.5 (32–77) | 61.5 (34–83) |
Sex, n (%) | |||||
Male | 20 (48) | 9 (38) | 19 (45) | 16 (38) | 17 (40) |
Female | 22 (52) | 15 (63) | 23 (55) | 26 (62) | 25 (60) |
Race, n (%) | |||||
White | 33 (79) | 21 (88) | 32 (76) | 37 (88) | 10 (24) |
Black or African American | 3 (7) | 2 (8) | 4 (10) | 1 (2) | 1 (2) |
Asian | 2 (5) | 1 (4) | 5 (12) | 2 (5) | 30 (71) |
Other | 4 (10) | 0 | 1 (2) | 2 (5) | 1 (2)a |
ECOG PS, n (%) | |||||
0 | 23 (55) | 11 (46) | 24 (57) | 10 (24) | 8 (19) |
1 | 19 (45) | 13 (54) | 18 (43) | 32 (76) | 34 (81) |
Cancer type, n (%) | |||||
CRCb | 23 (55) | 12 (50) | 42 (100) | 0 | 0 |
PDAC | 19 (45) | 12 (50) | 0 | 42 (100) | 0 |
EGFRm NSCLC | 0 | 0 | 0 | 0 | 42 (100) |
Time since initial diagnosis, median (range), months | 26.1 (9.6–176.5) | 31.5 (5.3–78.7) | 36.7 (12.1–116.4) | 14.8 (4.4–90.3) | 26.0 (5.5–212.1) |
Number of target lesions, median (range) | 2 (1–5) | 2 (1–5) | 3 (1–5) | 2 (1–5) | 2 (1–5) |
Prior lines of therapy,c n (%) | |||||
1 | 2 (5) | 4 (17) | 1 (2) | 15 (36) | 9 (21) |
2 | 14 (33) | 7 (29) | 13 (31) | 22 (52) | 16 (38) |
3 | 16 (38) | 7 (29) | 12 (29) | 5 (12) | 11 (26) |
≥ 4 | 10 (24) | 6 (25) | 16 (38) | 0 | 6 (14) |
Smoking history – yes, n (%) | 16 (38) | 8 (33) | 12 (29) | 10 (24) | 12 (29) |
ECOG PS Eastern Cooperative Oncology Group performance status, EGFRm epidermal growth factor receptor-mutant, MSI microsatellite instability, MSS-CRC microsatellite-stable colorectal cancer, NSCLC non-small-cell lung cancer, PDAC pancreatic ductal adenocarcinoma
aMultiple categories checked
bMSI status in patients with CRC was MSS for all patients with known status; unknown status in 11/23 (48%), 3/12 (25%), and 3/42 (7%) patients in the single-agent dose-escalation, combination dose-escalation, and CRC expansion cohorts, respectively
cAdjudicated