Table 2.
Summary of efficacy for Asia region patients and the overall population (ITT population)
| Asia region population | Overall ITT population | |||||||
|---|---|---|---|---|---|---|---|---|
| Combination therapy | Monotherapy | Combination therapy | Monotherapy | |||||
|
nal‐IRI+5‐FU/LV n=34 |
5‐FU/LV n=35 |
nal‐IRI n=50 |
5‐FU/LV n=48 |
nal‐IRI+5‐FU/LV n=117 |
5‐F/LV n=119 |
nal‐IRI n=151 |
5‐FU/LV n=149 |
|
| Overall survival | ||||||||
| Median OS time, mo | 8.9 | 3.7 | 5.8 | 4.3 | 6.1 | 4.2 | 4.9 | 4.2 |
| 95% CI | 4.4–10.4 | 2.7–6.4 | 4.8–7.4 | 3.1–5.7 | 4.8–8.9 | 3.3–5.3 | 4.2–5.6 | 3.6–4.9 |
| HRa | 0.51 | 0.83 | 0.67 | 0.99 | ||||
| 95% CI | 0.28–0.93 | 0.53–1.31 | 0.49–0.92 | 0.77–1.28 | ||||
| P‐valueb | .025 | .423 | .012 | .942 | ||||
| Progression‐free survival | ||||||||
| Median PFS time, mo | 4.0 | 1.4 | 2.8 | 1.4 | 3.1 | 1.5 | 2.7 | 1.6 |
| 95% CI | 1.5–5.7 | 1.3–2.0 | 1.5–4.1 | 1.3–1.9 | 2.7–4.2 | 1.4–1.8 | 2.1–2.9 | 1.4–1.8 |
| HRa | 0.48 | 0.69 | 0.56 | 0.81 | ||||
| 95% CI | 0.27–0.85 | 0.44–1.07 | 0.41–0.75 | 0.63–1.04 | ||||
| P‐valueb | .011 | .155 | <.001 | .100 | ||||
| Best overall response, n (%) | ||||||||
| ORR | 8.8 | 0 | 10.0 | 0 | 16.2 | 0.8 | 6.0 | 0.7 |
| P‐value | .114 | .056 | <.001 | .020 | ||||
| PR | 3 (8.8) | 0 | 5 (10.0) | 0 | 19 (16.2) | 1 (0.8) | 9 (6.0) | 1 (0.7) |
| SD | 15 (44.1) | 5 (14.3) | 18 (36.0) | 8 (16.7) | 39 (33.3) | 26 (21.8) | 54 (35.8) | 35 (23.5) |
| Non‐CR/non‐PD | 0 | 0 | 2 (4.0) | 0 | 3 (2.6) | 2 (1.7) | 3 (2.0) | 2 (1.3) |
| PD | 11 (32.4) | 18 (51.4) | 20 (40.0) | 24 (50.0) | 34 (29.1) | 56 (47.1) | 51 (33.8) | 71 (47.7) |
| NE | 5 (14.7) | 12 (34.3) | 5 (10.0) | 16 (33.3) | 22 (18.8) | 34 (28.6) | 34 (22.5) | 40 (26.8) |
| CBR | 18 (52.9) | 5 (14.3) | 23 (46.0) | 8 (16.7) | 58 (49.5) | 27 (22.6) | 63 (41.8) | 36 (24.2) |
| Tumor marker (CA19‐9) response | ||||||||
| CA19‐9 response rate, n/N (%) | 8/25 (32.0) | 2/26 (7.7) | 12/41 (29.3) | 4/36 (11.1) | 28/97 (28.9) | 7/81 (8.6) | 29/123 (23.6) | 12/105 (11.4) |
| P‐valuec | <.001 | .024 | <.001 | .024 | ||||
Best overall response is based on RECIST criteria v1.1.
Abbreviations: 5‐FU, 5‐fluorouracil; CBR, clinical benefit response (PR + SD); CI, confidence interval; CR, complete response; HR, hazard ratio; ITT, intention‐to‐treat; LV, leucovorin (folinic acid); mo, months; nal‐IRI, liposomal irinotecan; NE, not evaluable; ORR, objective response rate; PR, partial response; SD, stable disease.
Unstratified hazard ratios were derived using Cox’s proportional hazards model, with treatment as the independent variable.
Two‐sided P‐values from log‐rank test.
Two‐sided P‐values from pairwise comparisons of tumor marker response rates using Fisher’s exact test.