Table 3 Incidence of patients with cibisatamab ADAs and incidence of patients with complete loss of cibisatamab exposure in S1 and S2

From: CEA-CD3 bispecific antibody cibisatamab with or without atezolizumab in patients with CEA-positive solid tumours: results of two multi-institutional Phase 1 trials

 

S1 (without obinutuzumab)

S1 (with obinutuzumab pretreatment)

S2 (without Obinutuzumab)

N

n (%)

N

n (%)

N

n (%)

ADA positive at baseline

111

3 (2.7)

26

0

218

8 (3.7)

ADA-negative, persistent

110

55 (50)

26

15 (58)

219

64 (29)

ADA-positive, treatment-enhanced

110

1 (1)

26

0

219

2 (1)

ADA-positive, transient

110

10 (9)

26

9 (35)

219

39 (18)

ADA-positive, persistent

110

44 (40)

26

2 (8)

219

114 (52)

Complete LOE

116

30 (26)

27

0

228

42 (18)

  1. ADA Anti-drug antibody, LOE Loss of exposure.
  2. Treatment-emergent ADAs were classified and subclassified as either:
  3. 1) Treatment-induced ADA: Patient has negative or missing baseline ADA result(s) and ≥1 positive post-baseline ADA result.
  4. (a) Persistent: Patient has post-treatment ADA-positive samples for ≥16 weeks or the last ADA time point is positive
  5. (b) Transient: Patient has ≥1 post-treatment ADA-positive sample AND has only 1 ADA-positive sample or the time between the first and last ADA-positive sample is <16 weeks AND the last ADA sample is negative
  6. 2) Treatment-enhanced ADA: Patient has positive ADA result at baseline and ≥1 post-baseline titer result that is ≥0.60 titer units greater than the baseline titer result
  7. Complete LOE is defined as a cibisatamab exposure with target-binding competent PK assay (i.e., active concentration) that is not detectable at end of infusion. Note that N for on-treatment ADA status can be larger than for baseline status as patients are still eligible for some categories with missing baseline samples. Source data can be requested from the authors for academic research purposes
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