Table 2 Tumor responses per RECIST v1.1 in patients in cohort 4B with measurable disease

From: First-line zolbetuximab plus mFOLFOX6 and nivolumab in unresectable CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial

Parameter

Overall (n = 58)a

CLDN18.2 highb (n = 47)

CLDN18.2 intermediatec (n = 10)

BOR, n (%)

 CR

2 (3.4)

2 (4.3)

0

 PR

34 (58.6)

30 (63.8)

4 (40.0)

 SD

16 (27.6)

10 (21.3)

6 (60.0)

 PD

6 (10.3)

5 (10.6)

0

ORR, n (%)

 n (%)

36 (62.1)

32 (68.1)

4 (40.0)

 95% CI

(48.4–74.5)

(52.9–80.9)

(12.2–73.8)

DCR, n (%)

 n (%)

52 (89.7)

42 (89.4)

10 (100)

 95% CI

(78.8–96.1)

(76.9–96.5)

(69.2–100)

DOR

 Months, median (95% CI)

19.1 (10.8–NE)

NE (10.8–NE)

19.1 (3.5–NE)

  1. aOne patient was missing a value for CLDN18.2 expression.
  2. bDefined as ≥75% of tumor cells demonstrating moderate-to-strong membranous CLDN18 staining as determined by central IHC.
  3. cDefined as ≥50% to <75% of tumor cells demonstrating moderate-to-strong membranous CLDN18 staining as determined by central IHC.
  4. CR, complete response; NE, not estimable; PD, progressive disease; PR, partial response; SD, stable disease.
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