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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)