Table 2:

Tumour response assessment as per independent central review

	Patients (n=78)
Objective response*	34 (44%; 32–55)
Best overall response
Complete response	10 (13%)
Partial response	24 (31%)
Stable disease	28 (36%)
Progressive disease	9 (12%)
Not evaluable†	7 (9%)
Disease control‡	62 (79%; 69–88)
Durable disease control‡	49 (63%; 51–74)
Median observed time to response, months (IQR)§	1.9 (1.9-3.7)
Median duration of response	Not reached
Observed duration of response ≥6 months§	23 (68%)
Estimated proportion of patients who remained in response at 12 months§	87.8% (66.7-95.9)

Data are % (95% CI) or n (%), unless otherwise specified.

^*Not included among the responders are two patients who had progressive disease at initial response assessments as per independent central review, followed by subsequent responses (one partial response and one complete response, both ongoing at time of data cutoff).

^†Includes patients who did not undergo imaging studies after initiation of therapy or had imaging studies that were not evaluable.

^‡Disease control was defined as the proportion of patients with best overall response of complete response, partial response, or stable disease at the first response assessment (after approximately 56 days on treatment) and durable disease control defined as the proportion of patients with best overall response of complete response, partial response, or stable disease for at least 105 days.

^§Data from patients with confirmed complete or partial responses.