Endpoints and assessments
Tumour, Cancer
ADVERSE EVENT, DISEASE, TUMOUR, CANCER
The primary endpoint of this study was ORR, defined as the proportion of patients with a documented complete response (CR) or partial response (PR) per RECIST v1.1, as assessed by investigators. Tumour imaging was performed within 28 days prior to enrolment, every 9 weeks (±1 week) in the first 12 months of enrolment, and every 12 weeks (±1 week) thereafter. Computed tomography (CT) or magnetic resonance imaging techniques were used, with a preference for CT. The same imaging technique was used throughout the study for each individual patient. All known disease was documented at baseline as target or non-target lesions per RECIST v1.1.Secondary endpoints included: progression-free survival (PFS), duration of response (DoR), disease control rate (DCR), and clinical benefit rate (CBR), all by investigator per RECIST v1.1; and overall survival (OS), safety and tolerability, pharmacokinetic parameters, and the immunogenicity of tislelizumab. Safety and tolerability were assessed by the incidence and nature of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 22.0 and graded per National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.03. The assignment of immune-mediated AEs was assessed by investigators based on diagnostic test results and clinical judgement, and the exclusion of alternative explanations, in line with criteria defined in the study protocol. Other safety assessments included vital signs, electrocardiograms, laboratory analyses, and physical and ophthalmologic examinations. In addition, as an elevated incidence of hepatic AEs was observed with the combination of pamiparib and tislelizumab in the dose-escalation part of the study [