Investigational Drug
sasanlimab
TrialFetch AI Analysis
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Overview
Sasanlimab (PF-06801591) is an investigational, subcutaneously administered cancer immunotherapy. Human trial results include a phase 3 study in high-risk non–muscle-invasive bladder cancer and earlier studies in advanced cancers. (nature.com)
Mechanism of action
Sasanlimab is an antibody that binds PD-1, an immune-checkpoint receptor, and blocks its interaction with PD-1 ligands. This is intended to restore antitumor immune activity. (pmc.ncbi.nlm.nih.gov)
Efficacy
In the randomized phase 3 CREST trial, 1,055 patients with high-risk bladder cancer who had not previously received bacillus Calmette–Guérin (BCG) were assigned to sasanlimab plus BCG induction and maintenance, sasanlimab plus BCG induction only, or BCG induction and maintenance alone. At 36 months, estimated event-free survival was 82.1% with sasanlimab plus BCG induction and maintenance versus 74.8% with BCG alone (hazard ratio 0.68; 95% CI 0.49–0.94). Among patients with carcinoma in situ, complete-response rates were 89.8% and 85.2%, respectively. Sasanlimab paired with induction-only BCG did not significantly improve event-free survival over BCG induction and maintenance; no overall-survival difference had been demonstrated at the interim analysis. (nature.com)
In a separate, nonrandomized phase Ib/II study of sasanlimab alone, confirmed objective response rates were 16.4% among 68 patients with advanced non-small-cell lung cancer and 18.4% among 38 patients with advanced urothelial carcinoma. These results cannot establish a comparative benefit. (pubmed.ncbi.nlm.nih.gov)
Safety
In CREST, treatment-related adverse events of grade 3 or higher occurred in 29.1% of patients receiving sasanlimab plus BCG induction and maintenance, versus 6.3% receiving BCG alone. Treatment-related adverse events led 26.3% of patients in the combination arm to discontinue sasanlimab. No treatment-related deaths occurred in those two arms; two occurred in the sasanlimab plus induction-only BCG arm. In the earlier advanced-cancer study, 13.2% of patients had grade 3 or higher treatment-related adverse events. (nature.com)
Further reading
Last updated: Sep 2026
Active trials using sasanlimab
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with previously untreated, unresectable advanced or metastatic clear cell RCC (including sarcomatoid histology) or translocation RCC receive sasanlimab (an investigational anti–PD-1 antibody), palbociclib (a CDK4/6 inhibitor), and axitinib (a VEGF-pathway inhibitor).
ClinicalTrials.gov ID: NCT07123090
TrialFetch AI summary: Adults with high-risk non–muscle-invasive bladder cancer who are not undergoing radical cystectomy receive intravesical PF-08052667, an investigational integrin β6–targeted antibody–drug conjugate, alone or with intravesical BCG and/or subcutaneous sasanlimab, an anti–PD-1 antibody. Cohorts include patients with persistent or recurrent disease after BCG and some previously untreated patients.
ClinicalTrials.gov ID: NCT07206225
TrialFetch AI summary: Adults with measurable advanced clear cell RCC who have received checkpoint inhibition and a VEGF-pathway antagonist (or are ineligible for the latter), or with advanced papillary RCC regardless of prior treatment, receive oral palbociclib (a CDK4/6 inhibitor) plus subcutaneous sasanlimab (an investigational PD-1 antibody).
ClinicalTrials.gov ID: NCT05665361
