Table 3.
Clinical activity outcomes (enrolled analysis set)
| NSCLC | CRC | Other cancers | Total (part 2d) | |
|---|---|---|---|---|
| n = 18 | n = 20 | n = 22 | N = 60 | |
| Treatment duration, months, median (range)a | 10.3 (0.7–14.3) | 3.0 (0.7–18.5) | 6.3 (0.7–29.0)b | 6.3 (0.7–29.0)c |
| Duration of follow-up, months, median (range) | 11.0 (0.9–21.9) | 3.1 (0.8–18.9) | 9.5 (0.1–28.6) | 7.8 (0.1–28.6) |
| Investigator-assessed outcomes | ||||
| Best overall response with confirmation of CR/PR | ||||
| CR | 0 | 0 | 1 (4.5) | 1 (1.7) |
| PR | 10 (55.6) | 3 (15.0) | 8 (36.4) | 21 (35.0) |
| SD | 4 (22.2) | 13 (65.0) | 9 (40.9) | 26 (43.3) |
| PD | 3 (16.7) | 3 (15.0) | 3 (13.6) | 9 (15.0) |
| Not evaluable | 1 (5.6) | 1 (5.0) | 1 (4.5) | 3 (5.0) |
| ORR with confirmation of CR/PR, n/N (%) | 10/18 (55.6) | 3/20 (15.0) | 9/22 (40.9) | 22/60 (36.7) |
| 95% CI | (30.8–78.5) | (3.2–37.9) | (20.7–63.6) | (24.6–50.1) |
| DCR with confirmation of CR/PR/SD, n/N (%)d | 14/18 (77.8) | 16/20 (80.0) | 18/22 (81.8) | 48/60 (80.0) |
| 95% CI | (52.4–96.3) | (56.3–94.3) | (59.7–94.8) | (67.7–89.2) |
| TTR with confirmation, monthse | ||||
| n/N | 10/18 | 3/20 | 9/22 | 22/60 |
| Median (95% CI) | 2.1 (1.2–2.8) | 3.0 (1.4–8.1) | 1.6 (1.2–3.0) | 1.7 (1.4–2.9) |
| Min, max | 1.2, 5.4 | 1.4, 8.1 | 1.2, 5.7 | 1.2, 8.1 |
| Duration of response with confirmation, monthsf | ||||
| n/N | 10/18 | 3/20 | 9/22 | 22/60 |
| Median (95% CI) | 9.9 (6.9–11.5) | 7.4 (2.8–17.5) | 12.9 (3.0–NE) | 9.9 (9.0–17.5) |
| Min, max | 5.3+, 11.5 | 2.8, 17.5 | 3.0, 26.3+ | 2.8, 26.3+ |
| PFS, months | ||||
| Median (95% CI) | 11.3 (5.5–14.1) | 4.1 (2.1–5.9) | 11.1 (5.4–20.5) | 8.3 (5.4–11.8) |
| Assessment by independent central review | ||||
| Best overall response with confirmation of CR/PR | ||||
| CR | 0 | 0 | 1 (4.5) | 1 (1.7) |
| PR | 10 (55.6) | 1 (5.0) | 5 (22.7) | 16 (26.7) |
| SD | 5 (27.8) | 15 (75.0) | 12 (54.5) | 32 (53.3) |
| PD | 2 (11.1) | 2 (10.0) | 3 (13.6) | 7 (11.7) |
| Not evaluable | 1 (5.6) | 2 (10.0) | 1 (4.5) | 4 (6.7) |
| ORR with confirmation of CR/PR, n/N (%) | 10/18 (55.6) | 1/20 (5.0) | 6/22 (27.3) | 17/60 (28.3) |
| 95% CI | (30.8–78.5) | (0.1–24.9) | (10.7–50.2) | (17.5–41.4) |
| DCR with confirmation of CR/PR/SD, n/N (%)d | 15/18 (83.3) | 16/20 (80.0) | 18/22 (81.8) | 49/60 (81.7) |
| 95% CI | (58.6–96.4) | (56.3–94.3) | (59.7–94.8) | (69.6–90.5) |
| TTR with confirmation, monthse | ||||
| n/N | 10/18 | 1/20 | 6/22 | 17/60 |
| Median (95% CI) | 1.4 (1.2–2.8) | 3.0 (NE) | 1.6 (1.4–3.0) | 1.4 (1.4–2.9) |
| Min, max | 1.2, 5.8 | 3.0, 3.0 | 1.4, 3.0 | 1.2, 5.8 |
| Duration of response with confirmation, monthsf | ||||
| n/N | 10/18 | 1/20 | 6/22 | 17/60 |
| Median (95% CI) | 10.7 (6.9–11.5) | 13.4 (NE) | NR (3.0–NE) | 11.5 (7.0–NE) |
| Min, max | 3.3+, 11.5 | 13.4, 13.4 | 3.0, 21.1+ | 3.0, 21.1+ |
| PFS, months | ||||
| Median (95% CI) | 11.3 (7.2–14.3) | 4.0 (2.7–5.6) | 11.0 (2.8–NE) | 7.2 (4.8–11.1) |
| OS, months | ||||
| Median (95% CI) | NR (17.3–NE) | 15.6 (4.8–NE) | 23.4 (9.6–NE) | 23.4 (15.6–NE) |
| Min, max | 0.9, 21.9+ | 1.0+, 25.9+ | 0.1+, 28.6+ | 0.1+, 28.6+ |
NOTE: All values are n (%), unless otherwise specified. Data cutoff for this analysis was February 2019. The enrolled analysis set includes all patients with HER2-expressing non-breast/non-gastric solid tumors or HER2-mutant solid tumors who provided informed consent and were enrolled in the dose escalation or expansion. Min and max include the censored observations; using “+” after value indicates censoring.
Abbreviations: CR, complete response; CRC, colorectal cancer; DCR, disease control rate; max, maximum; min, minimum; NE, not estimable; NR, not reached; PR, partial response; SD, stable disease.
Safety analysis set.
n = 21.
n = 59.
DCR is calculated as the proportion of patients demonstrating CR, PR, or SD for a minimum of 5 weeks from date of first dose.
TTR was measured from the date of registration to the date at which criteria for CR or PR are first met.
Duration of response was measured from the time at which CR or PR criteria are first met, until the first date of objectively documented PD or death due to any cause.