Table 3 Antitumor activity in patients with HER2-expressing GEA (response evaluable analysis set)

From: Zanidatamab monotherapy or combined with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma: a phase 1 trial

 

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)

  1. Data are reported as n (%) [95% CI] unless otherwise stated.
  2. BOR best overall response, cBOR confirmed best overall response, CBR clinical benefit rate, CI confidence interval, cORR confirmed objective response rate, CR complete response, DCR disease control rate, DOR duration of response, GEA gastroesophageal adenocarcinoma, HER2+ human epidermal growth factor receptor 2-positive, mo months, NE not evaluable, PD progressive disease, PR partial response, QW every week, Q2W every 2 weeks, SD stable disease.
  3. aZanidatamab 10 mg/kg QW or 20 mg/kg Q2W.
  4. bZanidatamab 20 mg/kg Q2W or 25 mg/kg Q2W.
  5. cClinical benefit rate defined as SD ≥ 24 weeks or confirmed BOR of CR or PR.
  6. dDCR defined as cBOR of CR, PR, or SD.
  7. eAmong safety analysis set.