TABLE 3.
Subgroup Analysis of Confirmed ORR by Investigator Assessment and OS
| Parameter | Value | No. | ORR,a No. (%) | 95% CIb | Median OS,c Months | 95% CI |
|---|---|---|---|---|---|---|
| Prespecified analyses | ||||||
| All | 46 | 11 (23.9) | 12.6 to 38.8 | 6.0 | 4.4 to 10.7 | |
| Age group 1, years | <65 | 22 | 6 (27.3) | 10.7 to 50.2 | 6.0 | 3.4 to 10.7 |
| ≥65 | 24 | 5 (20.8) | 7.1 to 42.2 | 9.3 | 4.3 to NE | |
| Age group 2, years | <75 | 43 | 10 (23.3) | 11.8 to 38.6 | 6.0 | 4.3 to 10.7 |
| ≥75 | 3 | 1 (33.3) | 0.8 to 90.6 | 5.7 | 3.3 to NE | |
| Sex | Female | 6 | 1 (16.7) | 0.4 to 64.1 | 4.1 | 0.8 to NE |
| Male | 40 | 10 (25.0) | 12.7 to 41.2 | 6.0 | 4.4 to 10.7 | |
| Race | White | 27 | 5 (18.5) | 6.3 to 38.1 | 5.1 | 3.4 to 10.3 |
| Non-White | 16 | 5 (31.3) | 11.0 to 58.7 | 9.3 | 4.0 to NE | |
| Region | North America | 30 | 5 (16.7) | 5.6 to 34.7 | 5.2 | 3.8 to 10.3 |
| Japan | 16 | 6 (37.5) | 15.2 to 64.6 | 10.7 | 4.0 to NE | |
| ECOG PS | 0 | 16 | 7 (43.8) | 19.8 to 70.1 | NE | 8.7 to NE |
| ≥1 | 30 | 4 (13.3) | 3.8 to 30.7 | 4.6 | 3.8 to 6.0 | |
| Hemoglobin at baseline, g/dL | <10 | 7 | 0 | 0 to 41.0 | 4.1 | 0.8 to NE |
| ≥10 | 39 | 11 (28.2) | 15.0 to 44.9 | 8.7 | 5.1 to 10.7 | |
| Previous lines of therapy | <Three lines | 15 | 5 (33.3) | 11.8 to 61.6 | 9.3 | 3.3 to NE |
| ≥Three lines | 31 | 6 (19.4) | 7.5 to 37.5 | 5.7 | 4.0 to 10.7 | |
| Previous lines of therapy in metastatic setting | <Three lines | 16 | 4 (25.0) | 7.3 to 52.4 | 8.7 | 3.3 to NE |
| ≥Three lines | 24 | 5 (20.8) | 7.1 to 42.2 | 5.7 | 4.0 to 10.7 | |
| Previous use of taxane | Yes | 34 | 6 (17.6) | 6.8 to 34.5 | 5.1 | 4.0 to 10.3 |
| No | 12 | 5 (41.7) | 15.2 to 72.3 | NE | 3.3 to NE | |
| Best response to previous systemic therapy | Respondera | 25 | 8 (32.0) | 15.0 to 53.5 | 6.0 | 4.0 to 10.7 |
| Nonrespondera | 20 | 3 (15.0) | 3.2 to 37.9 | 6.0 | 3.8 to 14.2 | |
| Best response to most recent therapy | Respondera | 9 | 3 (33.3) | 7.5 to 70.1 | 8.7 | 0.8 to NE |
| Nonrespondera | 33 | 8 (24.2) | 11.1 to 42.3 | 6.0 | 4.4 to 14.2 | |
| Best response to previous PD-1/PD-L1 | Respondera | 7 | 3 (42.9) | 9.9 to 81.6 | NE | 2.3 to NE |
| Nonrespondera | 37 | 8 (21.6) | 9.8 to 38.2 | 5.7 | 4.1 to 10.3 | |
| Best response to previous platinum | Respondera | 24 | 8 (33.3) | 15.6 to 55.3 | 5.5 | 3.9 to 10.7 |
| Nonrespondera | 16 | 3 (18.8) | 4.1 to 45.7 | 10.3 | 4.1 to 14.2 | |
| Best response to previous taxane | Respondera | 12 | 3 (25.0) | 5.5 to 57.2 | 5.5 | 1.3 to 10.7 |
| Nonrespondera | 19 | 3 (15.8) | 3.4 to 39.6 | 5.7 | 2.8 to 14.2 | |
| Ad hoc analyses | ||||||
| ≤2 previous lines of systemic therapy and one previous line of cytotoxic therapy | Yes | 13 | 5 (38.5) | 13.9 to 68.4 | 11.4 | 2.5 to NE |
| No | 33 | 6 (18.2) | 7.0 to 35.5 | 6.0 | 4.3 to 9.3 | |
| Previous lines of cytotoxic therapy | 1 | 21 | 7 (33.3) | 14.6 to 57.0 | 11.4 | 4.1 to NE |
| >1 | 25 | 4 (16.0) | 4.5 to 36.1 | 5.7 | 3.9 to 8.7 | |
| Previous lines of systemic therapy | ≤2 | 15 | 5 (33.3) | 11.8 to 61.6 | 9.3 | 3.3 to NE |
| >2 | 31 | 6 (19.4) | 7.5 to 37.5 | 5.7 | 4.0 to 10.3 |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; NE, not evaluable; ORR, objective response rate; OS, overall survival.
a
Responder includes patients who had complete response or partial response as their best response. Nonresponder includes patients who had stable disease or progressive disease as their best response.
b
CI was estimated using exact method on the basis of binomial distribution (Clopper-Pearson).
c
On the basis of Kaplan-Meier estimate.