Skip to main content

Table 2 Efficacy outcomes

From: Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors

 

CRC

Non-CRC

Overall study population

(N = 103)

 

 ≥ 2 Prior therapies (N = 41)

1 Prior therapy (N = 24)

Total

(N = 65)

GC

(N = 18)

Other solid tumors

(N = 20)

Total

(N = 38)

BIRC

       

ORR

       

n (%)

13 (31.7)

15 (62.5)

28 (43.1)

8 (44.4)

8 (40.0)

16 (42.1)

44 (42.7)

95% CI

18.1–48.1

40.6–81.2

30.8–56.0

21.5–69.2

19.1–63.9

26.3–59.2

33.0–52.8

DCR

       

n (%)

24 (58.5)

16 (66.7)

40 (61.5)

15 (83.3)

13 (65.0)

28 (73.7)

68 (66.0)

95% CI

42.1–73.7

44.7–84.4

48.6–73.3

58.6–96.4

40.8–84.6

56.9–86.6

56.0–75.1

DoR

       

Range, months

1.05 + to 16.59 + 

2.76 + to 14.98 + 

1.87 to 14.98 + 

1.05 + to 16.59 + 

3.75 + to 14.72 + 

1.05 + to 16.59 + 

1.05 + to 16.59 + 

 ≥ 12 months, %

(95% CI)

74.6

(39.8–91.1)

100.0

(100.0–100.0)

88.4

(68.0–96.1)

100.0

(100.0–100.0)

100.0

(100.0–100.0)

100.0

(100.0–100.0)

92.2

(77.5–97.4)

PFS

       

Median (95% CI), months

4.9 (1.9–9.9)

NR (1.8–NE)

7.2 (3.5–NE)

NR (11.1–NE)

NR (1.9–NE)

NR (5.5–NE)

11.1 (5.5–NE)

Range, months

0.85 to 16.76 + 

0.76 to 18.27 + 

0.76 to 18.27 + 

1.41 to 18.43 + 

0.03 + to 16.62 + 

0.03 + to 18.43 + 

0.03 + to 18.43 + 

% at 12 months

(95% CI)

32.1 (18.1–47.0)

62.5 (40.3–78.4)

43.7 (31.2–55.4)

58.0 (18.3–84.0)

52.6 (28.7–71.9)

57.7 (37.3–73.5)

48.5 (37.8–58.3)

OS

       

Median (95% CI), months

NR (10.3–NE)

NR (NE–NE)

NR (NE–NE)

NR (NE–NE)

NR (5.9–NE)

NR (NE–NE)

NR (NE–NE)

% at 12 months

(95% CI)

64.7 (47.7–77.4)

87.1 (65.2–95.7)

72.9 (60.1–82.2)

83.3 (56.8–94.3)

75.0 (50.0–88.7)

78.9 (62.1–88.8)

74.6 (64.7–82.1)

  1. CRC with ≥ 2 prior therapies included patients previously treated with a fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimen
  2. CRC with 1 prior therapy included patients previously treated with a fluoropyrimidine- and oxaliplatin- or fluoropyrimidine- and irinotecan-containing regimen
  3. BIRC, blinded independent review committee; CI, confidence interval; CRC, colorectal cancer; DCR, disease control rate; DoR, duration of response; GC, gastric cancer; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival
  4. *For ORR, DCR, and DoR, each complete response and partial response as the best overall response was confirmed 4 weeks later (per RECIST Version 1.1)
  5. +Censored