Table 3 Clinical efficacy of PF-07248144
From: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial
PF-07248144 5 mg q.d. Part 2A (N = 35) | Combination PF-07248144 5 mg q.d. + fulvestrant 500 mg Parts 1B + 2B (N = 43) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
N = 35 | Total N = 43 | 2L N = 23 | 3L+ N = 20 | Fulv treated N = 5 | Fulv naive N = 38 | ESR1 MT N = 24 | ESR1 WT N = 18 | PIK3CA/AKT1/ PTEN MT N = 19 | PIK3CA/AKT1/ PTEN WT N = 23 | |
Objective response (CR + PR), n (%) | 4 (11.4) | 13 (30.2) | 5 (21.7) | 8 (40.0) | 3 (60.0) | 10 (26.3) | 8 (33.3) | 5 (27.8) | 5 (26.3) | 8 (34.8) |
95% CIa | 3.2–26.7 | 17.2–46.1 | 7.5–43.7 | 19.1–63.9 | 14.7–94.7 | 13.4–43.1 | 14.5–52.2 | 7.1–48.5 | 6.5–46.1 | 15.3–54.2 |
Median duration of response (95% CI)b | 12.0 (7.4–NE) | 9.2 (7.2–NE) | NE (5.5–NE) | 9.2 (7.2–NE) | N/A | N/A | 9.2 (5.8–NE) | NE (NE–NE) | 7.2 (5.5–NE) | NE (9.2–NE) |
Disease control (CR + PR + SD + non-CR/non-PD), n (%) | 18 (51.4) | 33 (76.7) | 16 (69.6) | 17 (85.0) | 5 (100.0) | 28 (73.7) | 21 (87.5) | 12 (66.7) | 13 (68.4) | 20 (87.0) |
95% CIa | 34.0–68.6 | 61.4–88.2 | 47.1– 86.8 | 62.1–96.8 | 47.8–100.0 | 56.9–86.6 | 67.6–97.3 | 41.0–86.7 | 43.4–87.4 | 66.4–97.2 |
CBR, n (%) | 11 (31.4) | 22 (51.2) | 10 (43.5) | 12 (60.0) | 4 (80.0) | 18 (47.4) | 12 (50.0) | 10 (55.5) | 9 (47.4) | 13 (56.5) |
95% CIa | 16.9–49.3 | 35.5–66.7 | 23.2– 65.5 | 36.1– 80.9 | 28.4–99.5 | 31.0–64.2 | 29.1–70.9 | 30.8–78.5 | 24.4–71.1 | 34.5–76.8 |
mPFS, 95% CIb | 3.3 (2.0–5.8) | 10.7 (5.3–NE) | NE (3.5–NE) | 10.7 (5.5–NE) | N/A | N/A | 10.7 (5.5–NE) | NE (3.5–NE) | 7.2 (2.8–NE) | 10.8 (5.6–NE) |
