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Table 2 Efficacy Outcomes

From: Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results

Category Patients Treated With Lenvatinib 24 mg Once Daily (N = 26)
Investigator Assessment IIR
Objective response rate, n (%)
(90% CI)
3 (11.5)
(3.2–27.2)
3 (11.5)
(3.2–27.2)
Best overall response, n (%)
 Complete response 0 0
 Partial response 3 (11.5) 3 (11.5)
 Stable disease 19 (73.1) 9 (34.6)
 Progressive disease 4 (15.4) 13 (50.0)
 Not evaluable 0 0
 Unknown 0 1 (3.8)
Disease control ratea, n (%)
(90% CI)
22 (84.6)
(68.2–94.6)
12 (46.2)
(29.2–63.8)
Clinical benefit rateb, n (%)
(90% CI)
10 (38.5)
(22.6–56.4)
6 (23.1)
(10.6–40.5)
PFS rate at 12 weeks, % (95% CI) 72.2 (50.4–85.7) 44.0 (24.5–61.9)
Median PFS, months (95% CI) 3.19 (2.79–7.23) 1.64 (1.41–3.19)
Median time to progression, months (95% CI) 4.11 (2.76–7.39) 1.64 (1.41–2.92)
Median overall survival, months (95% CI) 7.35 (4.50–11.27)
  1. CI confidence interval, IIR independent imaging review, PFS progression-free survival
  2. aThe proportion of patients with a best overall response of complete response, partial response or stable disease; stable disease needed to be achieved at cycle 2 day 8 or later
  3. bThe proportion of patients with complete response + partial response + durable stable disease (≥ 23 weeks)
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