Extended Data Table 1 Clinical activity in the efficacy population

From: Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial

  1. The efficacy population includes all randomized and dosed patients in Phase 2 and DLT-evaluable patients from Phase 1b enrolled at the recommended Phase 2 dose of sotiga. The 1-year overall survival (OS) rate and corresponding 1-sided, 95% lower confidence bound were estimated by the Kaplan-Meier method. P-values were calculated using a 1-sided, one-sample Z test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%. P-values were not adjusted for multiple comparisons. OS, progression-free survival, and duration of response and the corresponding 2-sided, 95% CIs were estimated by the Kaplan-Meier method. Abbreviations: CI = confidence interval; N or n = number; NE = not estimable.
  2. aNot evaluable includes patients who only had one tumor assessment with overall response of Not Evaluable (1 in nivo /chemo) or who did not have any post-baseline tumor assessments due to: initiation of another systemic cancer therapy after treatment discontinuation (1 in nivo /chemo, 2 in sotiga /chemo, 1 in sotiga/nivo/chemo), death (2 in sotiga/nivo/chemo), withdrawal of consent / lost to follow-up (1 each in nivo/chemo and sotiga/chemo), or inability due to clinical deterioration (1 each in nivo/chemo and sotiga/nivo/chemo).
  3. bDisease control rate is defined as the proportion of patients with a best overall response of complete or partial response or stable disease at least 7 weeks after study drug initiation.
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