Table 3 Antitumor activity in patients with HER2-expressing GEA (response evaluable analysis set)
Zanidatamab monotherapya | Zanidatamab plus chemotherapyb | |||
---|---|---|---|---|
All GEA patients (N = 28) | Patients with HER2 + GEA (n = 27) | All GEA patients (N = 37) | Patients with HER2 + GEA (n = 26) | |
cORR, n (%) [95% CI] | 9 (32.1) [15.9–52.4] | 8 (29.6) [13.8–50.2] | 18 (48.6) [31.9–65.6] | 13 (50.0) [29.9–70.1] |
cBOR, n (%) | ||||
CR | – | – | 2 (5.4) | 2 (7.7) |
PR | 9 (32.1) | 8 (29.6) | 16 (43.2) | 11 (42.3) |
SD | 8 (28.6) | 8 (29.6) | 12 (32.4) | 10 (38.5) |
PD | 11 (39.3) | 11 (40.7) | 7 (18.9) | 3 (11.5) |
CBR,c n (%) | 11 (39.3) | 10 (37.0) | 21 (56.8) | 16 (61.5) |
[95% CI] | [21.5–59.4] | [19.4–57.6] | [39.5–72.9] | [40.6–79.8) |
DCR,d n (%) | 17 (60.7) | 16 (59.3) | 30 (81.1) | 23 (88.5) |
[95% CI] | [40.6–78.5] | [38.8–77.6] | [64.8–92.0] | [69.8–97.6] |
DOR, median (95% CI) mo, | 6.7 (1.9–11.1) | 7.4 (1.9–11.1) | 18.3 (5.6–NE) | 18.9 (3.7–NE) |
[n] | [9] | [8] | [18] | [13] |
PFS,e median (95% CI) mo | 3.6 (1.8–7.2) | 3.6 (1.8–7.2) | 7.3 (5.4–11.5) | 7.6 (5.4–20.1) |
Had event, n/n (%) | 26/29 (89.7) | 25/28 (89.3) | 30/41 (73.2) | 18/27 (66.7) |
Censored, n/n (%) | 3/29 (10.3) | 3/28 (10.7) | 11/41 (26.8) | 9/27 (33.3) |