TABLE 1.
Baseline and Biomarker Characteristics
| Clinical Characteristic | Gemcitabine Alone (n = 36), No. (%) | Gemcitabine + M6620 (n = 34), No. (%) |
|---|---|---|
| Race | ||
| White | 34 (94) | 30 (88) |
| Asian | 0 (0) | 2 (6) |
| Unknown | 2 (6) | 2 (6) |
| ECOG | ||
| 0 | 22 (61) | 20 (59) |
| 1 | 14 (39) | 14 (41) |
| Platinum-freea interval, months | ||
| ≤3 | 13 (36) | 13 (38) |
| >3 to <6 | 23 (64) | 21 (62) |
| Previous total lines | ||
| <3 | 28 (78) | 23 (68) |
| ≥3 | 8 (22) | 11 (32) |
| Previous PARP inhibitor | ||
| Yes | 7 (19) | 11 (32) |
| No | 29 (81) | 23 (68) |
| Previous antiangiogenic therapy | ||
| Yes | 9 (25) | 10 (29) |
| No | 27 (75) | 24 (71) |
| BRCA mutation status | ||
| Yes | 5 (14) | 6 (18) |
| No | 25 (69) | 21 (62) |
| Unknown | 6 (17) | 7 (21) |
| RS biomarkerb | ||
| RS-low | 17 (47) | 13 (38) |
| RS-high | 13 (36) | 14 (41) |
| Unknown | 6 (17) | 7 (21) |
| Mutational signature 3 | ||
| Negative | 18 (50) | 16 (47) |
| Positive | 12 (33) | 11 (32) |
| Unknown | 6 (17) | 7 (21) |
| ATM expression by IHCc | ||
| Negative/low | 11 (31) | 13 (38) |
| Positive | 20 (56) | 16 (47) |
| Unknown | 5 (14) | 5 (15) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; IHC, immunohistochemistry; PARP, poly (ADP-ribose) polymerase; RS, replication stress.
a
Stratification factor.
b
RS-high tumors had ≥one of the following alterations: RB1 loss, CDKN2A loss, CCNE1 amplification, KRAS amplification, MYC/MYCL1 amplification, ERBB2 amplification, and NF1 mutations; RS-low had none of these alterations.
c
ATM expression was considered negative if there was no nuclear ATM staining in the tumor cells, low if nuclear ATM staining was present in <50% of tumor cells, and positive if ≥50% of tumor cells exhibited nuclear ATM staining.