Tumor response per independent central review and investigator assessment
| Endpoint | Conventional imaging (primary endpoint, n=63)* | Endpoint | FDG-PET imaging (exploratory endpoint, n=55)† | ||
| Independent central review | Investigator assessment | Independent central review | Investigator assessment | ||
| ORR, n (%) | 39 (61.9) | 40 (63.5) | ORR, n (%) | 35 (63.6) | 38 (69.1) |
| 95% CI‡ | 48.8–73.9 | 50.4–75.3 | 95% CI‡ | 49.6–76.2 | 55.2–80.9 |
| Complete response, n (%) | 14 (22.2) | 12 (19.0) | Complete metabolic response, n (%) | 17 (30.9) | 20 (36.4) |
| Partial response, n (%) | 25 (39.7) | 28 (44.4) | Partial metabolic response, n (%) | 18 (32.7) | 18 (32.7) |
| Stable disease, n (%) | 7 (11.1) | 6 (9.5) | Stable metabolic disease, n (%) | 5 (9.1) | 2 (3.6) |
| Non-complete response/non-progressive disease, n (%) | 3 (4.8) | ||||
| Progressive disease, n (%) | 9 (14.3) | 11 (17.5) | Progressive metabolic disease, n (%) | 3 (5.5) | 2 (3.6) |
| Not evaluable,§ n (%) | 5 (7.9) | 6 (9.5) | Not evaluable,§ n (%) | 12 (21.8) | 13 (23.6) |
| Disease control rate, n (%) | 49 (77.8) | 46 (73.0) | |||
| 95% CI‡ | 65.5–87.3 | 60.3–83.4 | |||
| Durable disease control rate, n (%) | 48 (76.2) | 45 (71.4) | |||
| 95% CI‡ | 63.8–86.0 | 58.7–82.1 | |||
| Number of doses, median (range) | 11 (1–24) | ||||
| Duration of exposure, median (range), weeks | 47.4 (4.0–97.0) | ||||
| Follow-up, median (range), months | 22.4 (1.0–39.8) | ||||
Data cut-off date: 20 April 2022.
*Conventional imaging data were reviewed first to establish the primary endpoint, and FDG-PET data were subsequently reviewed for the exploratory endpoint.
†Excludes patients from Germany as PET scans were not required for patients enrolled in Germany.
‡Clopper-Pearson exact CI.
§Includes missing and unknown tumor response.
FDG-PET, 18F-fluorodeoxyglucose positron emission tomography; NA, not applicable; ORR, objective response rate; PET, positron emission tomography.