Table 1.
Patient disposition and pre-treatment biomarkers
| All patients (n = 120) | |
|---|---|
| Sex, n (%)a | |
| Male | 49 (40.8) |
| Female | 71 (59.2) |
| Age (years), median (range) | 63 (30–77) |
| ≥65 years, n (%) | 54 (45.0) |
| ECOG performance status, n (%) | |
| 0 | 56 (46.7) |
| 1 | 64 (53.3) |
| Lines of prior systemic therapy, n (%) | |
| ≤3 | 69 (57.5) |
| 4 or more | 51 (42.5) |
| Prior platinum, n (%) | 81 (67.5) |
| Prior PARP inhibitor, n (%) | 39 (32.5) |
| Prior PD-(L)1 inhibitor, n (%) | 29 (24.2) |
| Tumor type, n (%) | |
| Ovarian | 22 (18.3) |
| Prostate | 21 (17.5) |
| Breast | 17 (14.2) |
| Pancreatic | 13 (10.8) |
| Sarcoma | 7 (5.8) |
| Otherb | 40 (33.3) |
| Enrollment gene, n | |
| ATM | 44 |
| BRCA1 | 25 |
| BRCA2 | 15 |
| CDK12 | 9 |
| RNAseH2 | 5 |
| PALB2 | 5 |
| SETD2 | 5 |
| Otherc | 12 |
| Enrollment test type, n | |
| Tissue NGS | 71 |
| Germline | 29 |
| ctDNA | 13 |
| IHC (RNAseH2/ATM) | 7 (5/2) |
| Central confirmation, n | |
| Tested | 109 |
| Confirmed | 83 |
| Unconfirmed | 26 |
| Not detected | 3 |
| Poor tissue quality | 10 |
| Alteration not covered | 13 |
| Origin, n | |
| Germline | 55 |
| Somatic | 42 |
| Undetermined (IHC enrollment) | 23 (7) |
| Allelic status, n | |
| Biallelic | 57 |
| Non-biallelic | 27 |
| Monoallelic | 20 |
| CHIP | 3 |
| No loss | 3 |
| Subclonal | 1 |
| Unknown | 36 |
| Indeterminate | 26 |
| Not tested | 9 |
| Inconsistent | 1 |
| Reversion, n | |
| Detected | 10 |
aSex (at birth) as reported by the patient to the study site. bOther tumor types included ampullary, appendix, bile duct, endometrial, gastrointestinal, head and neck squamous cell carcinoma, lung, melanoma, mesothelioma, sarcoma and skin. cOther enrollment genes included NBN (n = 4), RAD51B/C (n = 4) and CHEK2 (n = 4).
PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1.