Table 1.
Patient baseline characteristics according to combination regimen received
| Characteristic | Durvalumab–ceralasertib, n = 79 | Durvalumab plus other agents | |||
|---|---|---|---|---|---|
| All, pooled, n = 189 | Olaparib, n = 87 | Danvatirsen, n = 45 | Oleclumab, n = 57 | ||
| Age, median (range), years | 63.0 (42–80) | 64.0 (35–85) | 63.0 (35–85) | 65.0 (39–80) | 64.0 (37–79) |
| Age <65 years, n (%) | 45 (57.0) | 102 (54.0) | 49 (56.3) | 21 (46.7) | 32 (56.1) |
| Age ≥65 years, n (%) | 34 (43.0) | 87 (46.0) | 38 (43.7) | 24 (53.3) | 25 (43.9) |
| Male sex, n (%)a | 52 (65.8) | 103 (54.5) | 50 (57.5) | 23 (51.1) | 30 (52.6) |
| Race, n (%)b | n = 77 | n = 187 | n = 86 | n = 44 | n = 57 |
| White | 47 (61.0) | 124 (66.3) | 58 (67.4) | 29 (65.9) | 37 (64.9) |
| Asian | 9 (11.7) | 38 (20.3) | 23 (26.7) | 7 (15.9) | 8 (14.0) |
| Black or African American | 3 (3.9) | 4 (2.1) | 0 | 4 (9.1) | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 (0.5) | 0 | 0 | 1 (1.8) |
| Otherc | 18 (23.4) | 20 (10.7) | 5 (5.8) | 4 (9.1) | 11 (19.3) |
| ECOG PS, n (%)b | n = 79 | n = 188 | n = 87 | n = 44 | n = 57 |
| 0 | 28 (35.4) | 64 (34.0) | 20 (23.0) | 21 (47.7) | 23 (40.4) |
| 1 | 51 (64.6) | 123 (65.4) | 66 (75.9) | 23 (52.3) | 34 (59.6) |
| 2d | 0 | 1 (0.5) | 1 (1.1) | 0 | 0 |
| Histology, n (%) | |||||
| Adenocarcinoma | 55 (69.6) | 131 (69.3) | 62 (71.3) | 31 (68.9) | 38 (66.7) |
| Squamous cell carcinoma | 19 (24.1) | 43 (22.8) | 18 (20.7) | 12 (26.7) | 13 (22.8) |
| Large-cell carcinoma (NOS) | 2 (2.5) | 6 (3.2) | 4 (4.6) | 1 (2.2) | 1 (1.8) |
| Other | 3 (3.8) | 9 (4.8) | 3 (3.4) | 1 (2.2) | 5 (8.8) |
| Time from diagnosis, n (%)b | n = 79 | n = 184 | n = 85 | n = 43 | n = 56 |
| ≤12 months | 13 (16.6) | 44 (23.9) | 19 (22.4) | 14 (32.6) | 11 (19.6) |
| >12 months | 66 (83.5) | 140 (76.1) | 66 (77.6) | 29 (67.4) | 45 (80.4) |
| Group and cohort, n (%)b | |||||
| Group A, biomarker matched | 23 (29.1) | 65 (34.4) | 42 (48.3) | 0 | 23 (40.4) |
| Group B, biomarker nonmatched | 56 (70.9) | 124 (65.6) | 45 (51.7) | 45 (100) | 34 (59.6) |
| Primary resistance cohort | 23 (29.1) | 54 (28.6) | 22 (25.3) | 23 (51.1) | 9 (15.8) |
| Acquired resistance cohort | 33 (41.8) | 70 (37.0) | 23 (26.4) | 22 (48.9) | 25 (43.9) |
| Resistance classification (pooled groups A and B) | |||||
| Primary resistance | 30 (38.0) | 81 (42.9) | 39 (44.8) | 23 (51.1) | 19 (33.3) |
| Acquired resistance | 49 (62.0) | 108 (57.1) | 48 (55.2) | 22 (48.9) | 38 (66.7) |
| Disease classification, n (%)b | n = 79 | n = 188 | n = 87 | n = 44 | n = 57 |
| Metastatic | 77 (97.5) | 184 (97.9) | 87 (100) | 43 (97.7) | 54 (94.7) |
| Locally advanced | 2 (2.5) | 4 (2.1) | 0 | 1 (2.3) | 3 (5.3) |
| Metastatic sites, n (%) | |||||
| ≤2 | 31 (39.2) | 112 (59.3) | 40 (46.0) | 39 (86.7) | 33 (57.9) |
| ≥3 | 48 (60.8) | 77 (40.7) | 47 (54.0) | 6 (13.3) | 24 (42.1) |
| Metastatic site location, n (%) | |||||
| Bone and locomotor | 25 (31.6) | 57 (30.1) | 31 (35.6) | 7 (15.6) | 19 (33.3) |
| Adrenal gland | 15 (19.0) | 37 (19.6) | 19 (21.8) | 8 (17.8) | 10 (17.5) |
| Brain/CNS and/or other CNS | 12 (15.2) | 37 (19.6) | 21 (24.1) | 6 (13.3) | 10 (17.5) |
| Liver and/or hepatic (including gall bladder) | 14 (17.7) | 36 (19.0) | 15 (17.2) | 4 (8.9) | 17 (29.8) |
| PD-L1 status, locally assessed, n (%) | |||||
| Positive (TC ≥1%) | 42 (53.2) | 85 (45.0) | 27 (31.0) | 24 (53.3) | 34 (59.6) |
| 1–49% | 25 (31.6) | 46 (24.3) | 14 (16.1) | 14 (31.1) | 18 (31.6) |
| ≥50% | 17 (21.5) | 39 (20.6) | 13 (14.9) | 10 (22.2) | 16 (28.1) |
| Negative (TC <1%) | 21 (26.6) | 30 (15.9) | 16 (18.4) | 6 (13.3) | 8 (14.0) |
| Unknown | 16 (20.3) | 73 (38.6) | 43 (49.4) | 15 (33.3) | 15 (26.3) |
| Missing | 0 | 1 (0.5) | 1 (1.1) | 0 | 0 |
| Prior regimens, n (%) | |||||
| 1 | 15 (19.0) | 22 (11.6) | 12 (13.8) | 3 (6.7) | 7 (12.3) |
| 2 | 27 (34.2) | 85 (45.0) | 39 (44.8) | 22 (48.9) | 24 (42.1) |
| 3 | 22 (27.8) | 47 (24.9) | 20 (23.0) | 13 (28.9) | 13 (22.8) |
| ≥4 | 15 (19.0) | 35 (18.5) | 16 (18.4) | 7 (15.6) | 12 (21.1) |
| Prior immunotherapies, n (%) | |||||
| 1 | 77 (97.5) | 188 (99.5) | 87 (100) | 44 (97.8) | 57 (100) |
| 2 | 2 (2.5) | 1 (0.5) | 0 | 1 (2.2) | 0 |
| Prior anti-PD-(L)1 immunotherapy, n (%) | |||||
| Nivolumab | 36 (45.6) | 93 (49.2) | 51 (58.6) | 19 (42.2) | 23 (40.4) |
| Pembrolizumab | 33 (41.8) | 52 (27.5) | 20 (23.0) | 15 (33.3) | 17 (29.8) |
| Atezolizumab | 7 (8.9) | 26 (13.8) | 9 (10.3) | 8 (17.8) | 9 (15.8) |
| Durvalumab | 1 (1.3) | 17 (9.0) | 6 (6.9) | 4 (8.9) | 7 (12.3) |
| Cemiplimab | 0 | 1 (0.5) | 0 | 0 | 1 (1.8) |
| Prior anti-CTLA4 immunotherapy, n (%) | |||||
| Tremelimumab | 1 (1.3) | 5 (2.6) | 3 (3.4) | 1 (2.2) | 1 (1.8) |
| Ipilimumab | 0 | 2 (1.1) | 2 (2.3) | 0 | 0 |
| Best response on prior immunotherapy, n (%) | |||||
| Complete response | 0 | 2 (1.1) | 0 | 1 (2.2) | 1 (1.8) |
| Partial response | 17 (21.5) | 54 (28.6) | 25 (28.7) | 12 (26.7) | 17 (29.8) |
| Stable disease | 40 (50.6) | 64 (33.9) | 29 (33.3) | 8 (17.8) | 27 (47.4) |
| Stable disease, biomarker-matched patients | 11 (13.9) | 27 (14.3) | 15 (17.2) | 0 | 12 (21.1) |
| Stable disease, biomarker-nonmatched patients | 29 (36.7) | 37 (19.6) | 14 (16.1) | 8 (17.8) | 15 (26.3) |
| Progressive disease | 16 (20.3) | 57 (30.2) | 24 (27.6) | 22 (48.9) | 11 (19.3) |
| Nonevaluable | 3 (3.8) | 10 (5.3) | 7 (8.0) | 2 (4.4) | 1 (1.8) |
| Not applicable | 1 (1.3) | 1 (0.5) | 1 (1.1) | 0 | 0 |
| Time from prior immunotherapy | n = 77 | n = 188 | n = 86 | n = 45 | n = 57 |
| Median, months (range) | 3.9 (0.7–31.4) | 3.2 (0.7–50.1) | 2.5 (0.7–50.1) | 3.7 (0.8–30.3) | 3.7 (0.8–24.7) |
| Prior immunotherapy and resistance classification | |||||
| Primary resistance, n (%) | 29 (36.7) | 80 (42.3) | 38 (43.7) | 23 (51.1) | 19 (33.3) |
| Prior monotherapy | 22 (27.8) | 63 (33.3) | 31 (35.6) | 21 (46.7) | 11 (19.3) |
| Prior combination | 5 (6.3) | 16 (8.5) | 7 (8.0) | 2 (4.4) | 7 (12.3) |
| Both monotherapy and combination | 2 (2.5) | 1 (0.5) | 0 | 0 | 1 (1.8) |
| Acquired resistance, n (%) | 48 (60.8) | 108 (57.1) | 48 (55.2) | 22 (48.9) | 38 (66.7) |
| Prior monotherapy | 36 (45.6) | 85 (45.0) | 36 (41.4) | 18 (40.0) | 31 (54.4) |
| Prior combination | 7 (8.9) | 18 (9.5) | 10 (11.5) | 4 (8.9) | 4 (7.0) |
| Both monotherapy and combination | 5 (6.3) | 5 (2.6) | 2 (2.3) | 0 | 3 (5.3) |
| Not available, n (%) | 2 (2.5) | 1 (0.5) | 1 (1.1) | 0 | 0 |
| Prior platinum-based therapies, n (%) | |||||
| 1 | 62 (78.5) | 154 (81.5) | 70 (80.5) | 39 (86.7) | 45 (78.9) |
| 2 | 15 (19.0) | 28 (14.8) | 14 (16.1) | 4 (8.9) | 10 (17.5) |
| ≥3 | 2 (2.5) | 7 (3.7) | 3 (3.4) | 2 (4.4) | 2 (3.5) |
| Smoking status, n (%) | |||||
| Never | 9 (11.4) | 28 (14.8) | 18 (20.7) | 5 (11.1) | 5 (8.8) |
| Current | 18 (22.8) | 23 (12.2) | 6 (6.9) | 6 (13.3) | 11 (19.3) |
| Former | 52 (65.8) | 138 (73.0) | 63 (72.4) | 34 (75.6) | 41 (71.9) |
aSex as recorded by investigator in the case report form.
bFor parameters for which data are missing, the numbers of patients with data are indicated for each regimen and are used as the denominators for calculating percentages.
cRecorded as ‘Other’ in the case report form.
dPatient did not meet the eligibility criterion for ECOG PS of 0–1.
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; NOS, not otherwise specified.