Table 2.
Efficacy outcomes by nadunolimab dose level classified using RECIST and iRECIST (mITT population).
| Outcome | 1.0 mg/kg (N = 20) | 2.5 mg/kg (N = 20) | 5.0 mg/kg (N = 25) | 7.5 mg/kg (N = 8) | All patients with PDAC (N = 73) |
|---|---|---|---|---|---|
| OS | |||||
| Median—months (95% CI) | 12.9 (9.9–25.7) | 14.2 (6.9–15.6) | 12.6 (6.5–24.6) | 13.0 (0.7–25.7) | 13.2 (11.0–15.6) |
| Survival rate: | |||||
| 12 months, % (95% CI) | 63 (38–81) | 56 (31–75) | 54 (33–71) | 63 (23–86) | 58 (46–69) |
| 24 months, % (95% CI) | 32 (13–52) | 22 (7–43) | 32 (14–51) | 25 (4–56) | 28 (18–39) |
| 36 months, % (95% CI) | 13 (22–33) | 15 (2.9–36) | 12 (2.4–30) | 0 | 9 (3–21) |
| RECIST 1.1 | |||||
| Response | |||||
| ORR % (95% CI)a | 45 (23–69) | 30 (12–54) | 20 (7–41) | 38 (9–76) | 32 (21–43) |
| PR, n (%) | 9 (45) | 6 (30) | 5 (20) | 3 (38) | 23 (32) |
| SD, n (%) | 6 (30) | 8 (40) | 13 (52) | 1 (13) | 28 (38) |
| PD, n (%) | 2 (10) | — | 5 (20) | 3 (38) | 10 (14)b |
| Not evaluable, n (%) | 3 (15) | 6 (30) | 2 (8) | 1 (13) | 12 (16) |
| DCR % (95% CI)c | 75 (51–91) | 70 (46–88) | 72 (51–88) | 50 (16–84) | 71 (59–81) |
| DoR | |||||
| Median—months (95% CI) | 5.6 (3.6–11.8) | 7.4 (3.7–NE) | 11.1 (5.5–NE) | 3.9 (3.7–NE) | 6.5 (5.5–10.0) |
| PFS | |||||
| Median—months (95% CI) | 7.2 (2.7–9.2) | 7.3 (4.9–9.3) | 3.7 (1.9–7.1) | 3.7 (0.6–8.5) | 5.6 (3.7–7.4) |
| 6 months, % (95% CI) | 61 (35–79) | 56 (30–76) | 35 (17–54) | 25 (4–56) | 46 (33–58) |
| 12 months, % (95% CI) | 17 (4–37) | 19 (5–40) | 18 (6–35) | 0 | 15 (8–25) |
| iRECIST | |||||
| iResponse | |||||
| iORR % (95% CI)a | 45 (23–69) | 30 (12–54) | 20 (7–41) | 38 (9–76) | 31 (21–43) |
| Benefit beyond initial PD, n (%) | — | — | 5 (20) | — | 5 (7) |
| iDCR % (95% CI)b | 80 (56–94) | 70 (46–88) | 80 (59–93) | 75 (35–97) | 77 (65–86) |
| iDoR | |||||
| Median—months (95% CI) | 5.6 (3.6–11.8) | 8.5 (3.7–NE) | 11.1 (5.5–NE) | 3.9 (3.7–NE) | 7.2 (5.5–10.0) |
| iPFS | |||||
| Median—months (95% CI) | 7.2 (3.7–9.2) | 7.4 (5.1–11.2) | 5.6 (2.8–9.3) | 3.7 (0.–8.5) | 7.1 (5.2–7.4) |
Abbreviations: CI, confidence interval; CR, complete response; iDCR, immune disease control rate; iDoR, immune duration of response; iORR, immune overall response rate; iUPD, immune unconfirmed progressive disease; mITT population, modified intention-to-treat population; NE, not estimable; SD, stable disease.
a
ORR = CR + PR.
b
5/10 patients had PD/immune confirmed PD.
c
Disease control = PR + SD + at least two consecutive iUPD per iRECIST.