Table 2.
Overall efficacy (BICR assessed) of entrectinib in patients with NTRK fusion-positive solid tumors, by baseline investigator-assessed CNS metastases status.
| Efficacy-evaluable population | Baseline CNS metastasesa | No baseline CNS metastasesa | |
|---|---|---|---|
| Efficacy parameter | (n = 121) | (n = 26) | (n = 95) |
| ORR, n (%) | 74 (61.2) | 15 (57.7) | 59 (62.1) |
| (95% CI) | (51.9–69.9) | (36.9–76.7) | (51.6–71.9) |
| CR | 19 (15.7) | 2 (7.7) | 17 (17.9) |
| PR | 55 (45.5) | 13 (50.0) | 42 (44.2) |
| Stable disease | 13 (10.7) | 4 (15.4) | 9 (9.5) |
| Progressive disease | 13 (10.7) | 2 (7.7) | 11 (11.6) |
| Non-CR/non-PDb | 6 (5.0) | 0 | 6 (6.3) |
| Missing or unevaluablec | 15 (12.4) | 5 (19.2) | 10 (10.5) |
| DoR | n = 74 | n = 15 | n = 59 |
| Median, mo (95% CI) | 20.0 (13.0–38.2) | 17.2 (6.0–29.4) | 29.0 (12.9–NE) |
| PFS | |||
| Median, mo (95% CI) | 13.8 (10.1–19.9) | 11.7 (4.7–30.2) | 13.8 (10.2–20.8) |
| OS | |||
| Median, mo (95% CI) | 33.8 (23.4–46.4) | 19.9 (7.9–NE) | 37.1 (23.9–NE) |
Note: Data cut-off August 31, 2020.
aCNS metastases status determined by investigator.
bPatients with nonmeasurable lesions.
cMissing or unevaluable included patients with unevaluable on-study scans or who discontinued prior to obtaining adequate scans to evaluate or confirm response.