Table 2.
Summary of efficacy.
| Total enrolled N = 80 | VEGFRi-naïve n = 66 | VEGFRi-treated n = 14 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Investigator | BIRC | Investigator | BIRC | Investigator | BIRC | ||||
| Response (efficacy-evaluable populationa) | |||||||||
| Evaluable patients, n | 72 | 72 | 59 | 59 | 13 | 13 | |||
| Objective response, n (%, 95% CI) | 11 (15.3, 7.9–25.7) | 7 (9.7, 4.0– 19.0) | 11 (18.6, 9.7–30.9) | 5 (8.5, 2.8– 18.7) | 0 (0, 0–24.7) | 2 (15.4, 1.9– 45.4) | |||
| Best overall response, n (%) | |||||||||
| Complete response | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Partial response | 11 (15.3) | 7 (9.7) | 11 (18.6) | 5 (8.5) | 0 | 2 (15.4) | |||
| Stable disease | 54 (75.0) | 61 (84.7) | 43 (72.9) | 51 (86.4) | 11 (84.6) | 10 (76.9) | |||
| Progressive disease | 7 (9.7) | 4 (5.6) | 5 (8.5) | 3 (5.1) | 2 (15.4) | 1 (7.7) | |||
| Disease control rate, n (%, 95% CI) | 47 (65.3, 53.1–76.1) | 48 (66.7, 54.6–77.3) | 37 (62.7, 49.1–75.0) | 39 (66.1, 52.6–77.9) | 10 (76.9, 46.2–95.0) | 9 (69.2, 38.6–90.9) | |||
| Median duration of response, months (95% CI) | 14.9 (4.9–17.3) | 7.2 (3.5–8.4) | 14.9 (4.9–17.3) | 7.9 (3.5–8.4) | NE (NE–NE) | 6.3 (5.5–7.1) | |||
| Median time to progression, months (95% CI) | 9.2 (8.5–13.8) | 9.3 (8.5–13.6) | 9.0 (7.5–13.7) | 10.8 (8.5–13.8) | 16.4 (8.9–19.1) | 8.9 (5.3–12.9) | |||
| Time-to-progression landmark analyses, % (95% CI) | |||||||||
| 6 months | 77.3 (65.1–85.7) | 80.7 (68.5–88.6) | 75.6 (61.6–85.1) | 80.2 (66.2–88.9) | 84.6 (51.2–95.9) | 83.1 (47.2–95.5) | |||
| 9 months | 57.8 (44.3–69.2) | 57.3 (43.1–69.2) | 54.6 (39.8–67.2) | 59.3 (43.6–72.0) | 70.5 (30.6–90.2) | 44.5 (12.0–73.4) | |||
| 12 months | 44.3 (31.1–56.7) | 41.0 (27.0–54.4) | 41.5 (27.5–54.9) | 42.7 (27.2–57.3) | 56.4 (18.9–82.1) | 29.7 (4.8–61.6) | |||
| Progression-free survival (ITT population) | |||||||||
| Evaluable patients, n | 80 | 80 | 66 | 66 | 14 | 14 | |||
| Median progression-free survival, months (95% CI) | 9.0 (7.3–11.5) | 9.0 (7.7–11.5) | 8.6 (7.2–12.8) | 9.2 (7.7–13.7) | 9.1 (2.2–17.7) | 7.3 (5.3–12.9) | |||
| Progression-free survival landmark analyses, % (95% CI) | |||||||||
| 6 months | 73.1 (61.0–82.0) | 77.1 (64.9–85.6) | 71.9 (58.2–81.8) | 77.3 (63.4–86.5) | 78.6 (47.2–92.5) | 76.6 (43.3–91.9) | |||
| 9 months | 51.3 (38.7–62.5) | 51.1 (37.8–62.9) | 49.2 (35.4–61.6) | 54.0 (39.2–66.8) | 59.9 (27.8–81.4) | 35.9 (9.8–63.6) | |||
| 12 months | 38.0 (26.2–49.7) | 36.5 (23.9–49.2) | 37.4 (24.6–50.2) | 38.9 (24.6–52.9) | 39.9 (13.0–66.2) | 23.9 (4.0–52.9) | |||
| Overall survival (ITT population) | |||||||||
| Evaluable patients, n | 80 | 66 | 14 | ||||||
| Median overall survival, months (95% CI) | NE | NE | 17.5 (10.0–NE) | ||||||
| Overall survival landmark analyses, % (95% CI) | |||||||||
| 6 months | 94.7 (86.4–98.0) | 95.1 (85.5–98.4) | 92.9 (59.1–99.0) | ||||||
| 9 months | 83.5 (72.8–90.3) | 83.0 (70.7–90.5) | 85.7 (53.9–96.2) | ||||||
| 12 months | 74.5 (62.5–83.1) | 77.4 (64.2–86.2) | 62.9 (32.3–82.6) | ||||||
| 18 months | 61.7 (48.3–72.5) | 66.0 (51.1–77.3) | 45.8 (18.3–69.9) | ||||||
Abbreviations: IQR, interquartile range; NE, not estimable.
aAll patients who received at least one dose of rivoceranib, had at least one postbaseline tumor assessment, and were evaluable per RECIST v1.1.