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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