ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
Subcutaneously Administered Tislelizumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Pharmacokinetics and Safety Results from the BGB-A317-103 Phase I Study.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer.Clinical and translational science · 2026Trial
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25 authors.
Funding
Abstract
purposeTislelizumab, an anti-PD-1 monoclonal antibody, is approved for various indications intravenously. Subcutaneous delivery offers potential advantages in convenience and resource utilization. BGB-A317-103 assessed pharmacokinetics, safety, and efficacy of subcutaneous tislelizumab in treatment-naïve patients with advanced or metastatic non-small cell lung cancer. PATIENTS AND
methodsBGB-A317-103 is an open-label, multicenter, phase I study. In part 1 (dose/injection site exploration), patients received subcutaneous tislelizumab (abdomen or thigh injections; 300 mg) in two of the first three cycles and intravenous tislelizumab (200 mg) in the remaining cycle, followed by intravenous tislelizumab thereafter. In part 2 (dose expansion), patients received 300 mg of subcutaneous tislelizumab in the thigh in all cycles. Both parts included chemotherapy during the first four to six cycles. Pharmacokinetics, bioavailability, efficacy, immunogenicity, and safety were assessed.
resultsAt data cutoff (December 6, 2024), in part 1 (N = 39), subcutaneous administration yielded higher trough concentrations than intravenous [geometric means: 23.1 μg/mL (thigh), 19.5 μg/mL (abdomen), and 14.8 μg/mL (intravenously)]. Estimated bioavailability was 85.6% for thigh and 72.4% for abdomen. In part 2 (N = 22), subcutaneous tislelizumab in the thigh showed consistent pharmacokinetics with part 1. Preliminary analysis showed an overall response rate of 44.4%; the median duration of response and median progression-free survival were not reached. Tislelizumab's safety profile was consistent with previous studies, with no new signals or injection-site reactions.
conclusionsSubcutaneous tislelizumab demonstrated high bioavailability after thigh and abdomen injections. Safety and efficacy were consistent with previous tislelizumab plus chemotherapy studies, warranting further investigation of subcutaneous tislelizumab.
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