ArticleTherapeutic advances in medical oncology2024
Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies.
Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04181788 (A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, EFFICACY, AND PHARMACODYNAMICS OF PF-06801591), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1b/2 open-label study to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of pf-06801591 (pd-1 inhibitor) in participants with advanced malignancies
Who cites it
1 citing paper in PubMed.
- Population Pharmacokinetics and Exposure-Response of Sasanlimab, a Checkpoint Inhibitor, in Patients with Non-Muscle Invasive Bladder Cancer and Other Solid Tumors.Journal of clinical pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Sasanlimab (PF-06801591), a humanized immunoglobulin G4 monoclonal antibody, binds to programmed cell death protein-1 (PD-1), preventing ligand (PD-L1) interaction. Objectives: To evaluate pharmacokinetics (PK), safety, tolerability, and efficacy of two subcutaneous sasanlimab dosing regimens. Design: An open-label study consisting of phases Ib and II. Phase Ib: non-randomized, dose escalation, and expansion study in Asian participants with advanced malignancies. Phase II: conducted globally in participants with non-small-cell lung cancer with PD-L1 positive or PD-L1 status unknown tumors; participants were randomized 1:2 to receive subcutaneous sasanlimab 300 mg once every 4 weeks (300 mg-Q4W) or 600 mg once every 6 weeks (600 mg-Q6W). Methods: Primary endpoint in phase Ib: dose-limiting toxicity (DLT) occurring in first treatment cycle; in phase II: Results: A total of 155 participants (phase Ib, Conclusions: Phase Ib regimens were considered safe with no DLTs reported. In phase II, 600 mg-Q6W regimen criteria were met for AUC Trial registration: NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT).
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