Table 1.
Clinical characteristics and numbers in correlative study elements (n=24)
| Age (years) | |
| Median (IQR) | 64.0 (58.0 to 69.5) |
| Number of previous treatments (n, %) | |
| 1 | 1 (4%) |
| 2 | 8 (33%) |
| ≥3 | 15 (63%) |
| Median (range) | 4.5 (1 to 13) |
| Platinum sensitivity* (n, %) | |
| Platinum-sensitive | 5 (21%) |
| Platinum-resistant | 18 (75%) |
| Platinum-refractory | 1 (4%) |
| Best RECIST response (n, %) | |
| PR | 8 (33%) |
| SD ≥6 months | 6 (25%) |
| Total CBR (PR+SD ≥6 months) | 14 (58%) |
| SD <6 months | 3 (13%) |
| PD | 7 (29%) |
| Correlative studies (n, %) | |
| Tumor biopsies | |
| Pre-treatment | 18 (75%)† |
| Post-treatment | 12 (50%)† |
| Paired | 9 (38%) |
| Flow cytometry | 23 (96%)‡ |
| Immunohistochemistry | 21 (88%)§ |
| CBC | 24 (100%) |
*Platinum-sensitive: recurs 6 or more months after cessation of last platinum-based chemotherapy; platinum-resistant: progression within 6 months of last platinum-based therapy; platinum-refractory: progression while actively on platinum-based therapy.
†All 24 patients had baseline biopsies performed, however six were determined to be non-tumor tissue by RNAseq analysis and were excluded from analysis. Thirteen patients had an optional second biopsy performed, and one was determined to be of non-tumor origin and excluded.
‡C1D15 PBMCs from one patient were missing.
§Archival tissue from one patient was exhausted prior to enrollment in the trial and was unevaluable in two patients due tissue fragmentation and lack of stroma.
CBC, complete blood count; CBR, clinical benefit rate; PBMC, peripheral blood mononuclear cells; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; RNAseq, RNA sequencing; SD, stable disease.