Table 1 The demographic and clinical characteristics

From: Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study

 

Phase 1ba

Phase 2

Total

  

GC/GEJ cancer

Other HER2-positive tumors

 
 

n = 47

(n = 40)

CRC (n = 15)

Non-CRCb (n = 11)

n = 113

Median age, years (range)

56.0 (29.0, 74.0)

63.0 (34.0, 82.0)

55.0 (37.0, 67.0)

58.0 (41.0, 65.0)

57.0 (29.0, 82.0)

Sex

 Male

32 (61.8%)

29 (72.5%)

8 (53.3%)

4 (36.4%)

73 (64.6%)

 Female

15 (31.9%)

11 (27.5%)

7 (46.7%)

7 (63.6%)

40 (35.4%)

ECOG

 0

6 (12.8%)

8 (20.0%)

6 (40.0%)

3 (27.3%)

23 (20.4%)

 1

41 (87.2%)

32 (80.0%)

9 (60.0%)

7 (63.6%)

89 (78.8%)

 NA

0

0

0

1 (9.1%)

1 (0.9%)

HER2 statusc

 HER2 positive

38 (80.9%)

40 (100.0%)

15 (80.0%)

10 (90.9%)

103 (91.2%)

 HER2 low-expression

7 (14.9%)

0

0

0

7 (6.2%)

 HER2 mutation

2 (4.3%)

0

0

1 (9.1%)

3 (2.7%)

Liver metastasis

 Yes

28 (59.6%)

28 (70.0%)

10 (66.7%)

5 (45.5%)

71 (62.8%)

 No

19 (40.4%)

12 (30.0%)

5 (33.3%)

6 (54.5%)

42 (37.2%)

Peritoneal metastasis

 Yes

7 (14.9%)

2 (5.0)

0

0

9 (8.0%)

 No

40 (85.1%)

38 (95.0)

15 (100.0%)

11 (100.0%)

104 (92.0%)

Lymph node metastasis

 Yes

13 (27.7%)

13 (32.5%)

1 (6.7%)

4 (36.4%)

31 (27.4%)

 No

34 (72.3%)

27 (67.5%)

14 (93.3%)

7 (63.6%)

82 (72.6%)

Treatment naïve

7 (14.9%)

32 (80.0%)

0

0

39 (34.5%)

Pretreated patients

40 (85.1%)

8 (20.0%)

15 (100.0%)

11(100.0%)

74 (65.5%)

 Prior anti-HER2 therapiesd

21 (52.5%)

4 (50.0%)

4 (26.7%)

1 (9.1%)

30 (40.5%)

 Prior PD-1/PD-L1 blockades

10 (25.0%)

2 (25.0%)

1 (6.7%)

5 (45.5%)

18 (24.3%)

 Both anti-HER2 therapies and PD-1/ PD-L1 blockades

5 (12.5%)

2 (25.0%)

0

0

7 (9.5%)

  1. aIn phase 1b part, 47 patients included GC (n = 34), CRC (n = 11), duodenum cancer (n = 1), abdominal cavity cancer (n = 1)
  2. bNon-CRC cancer included renal cancer (n = 1), gallbladder cancer (n = 4), pancreatic cancer (n = 1), non-small cell lung cancer (n = 5)
  3. cHER2 positive included HER2 IHC 3+, HER2 IHC 2+ with gene amplification confirmed by ISH method, and NGS HER2 copy number >6
  4. dAnti-HER2 therapies included trastuzumab, pertuzumab, pyrotinib, disitamab vedotin (RC48), MBS301(a novel bispecific HER2 ECD2/ECD4 antibody)
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