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Table 2 Efficacy of geptanolimab

From: Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)

Endpoint Full analysis set All patients enrolled
Investigator assessed (n = 89) IRRC assessed (n = 89) Investigator assessed (n = 102) IRRC assessed (n = 102)
ORR
 No. of patients 34 36 37 39
 % of patients (95% CI) 38.2 (28.1 to 49.1) 40.4 (30.2 to 51.4) 36.3 (27.0 to 46.4) 38.2 (28.8 to 48.4)
DCR
 No. of patients 49 53 54 57
 % of patients (95% CI) 55.1 (44.1 to 65.6) 59.6 (48.6 to 69.8) 52.9 (42.8 to 62.9) 55.9 (45.7 to 65.7)
Objective response, n (%)
 CR 8 (9.0) 13 (14.6) 8 (7.8) 14 (13.7)
 PR 26 (29.2) 23 (25.8) 29 (28.4) 25 (24.5)
 SD 15 (16.9) 17 (19.1) 17 (16.7) 18 (17.6)
 PD 32 (36.0) # 28 (31.5) 37 (36.3)& 34 (33.3)
 Not reported§ 8 (9.0) 8 (9.0) 11 (10.8) 11 (10.8)
Median DOR, months
 Median (95% CI) 4.0 (1.5 to NR) 11.4 (4.8 to NR) 4.2 (1.5 to NR) 7.4 (5.1 to NR)
 % of patients ≥ 6 months (95% CI) 46.9 (29.1 to 62.8) 60.5 (41.8 to 74.8) 48.6 (31.4 to 63.7) 60.9 (43.0 to 74.7)
 % of patients ≥ 12 months (95% CI) 46.9 (29.1 to 62.8) 48.5 (29.6 to 65.0) 40.8 (23.9 to 57.0) 43.8 (26.3 to 60.0)
  1. ORR, objective response rate; DCR, disease control rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; IRRC, independent radiological review committee; DOR, duration of response; CI, confidence interval; NR, not reached
  2. #21 patients had confirmed progressive disease; 11 patients with a first progressive disease and still under treatment
  3. &23 patients had confirmed progressive disease; 14 patients with a first progressive disease and still under treatment
  4. §Patients did not have post-baseline efficacy evaluation due to early termination or protocol violation