Reference Detail

Ref Type

Journal Article

PMID

(37385154)

Authors

Cho BC, Penkov K, Bondarenko I, Kurochkin A, Pikiel J, Ahn HK, Korożan ME, Osipov M, Odintsova S, Braiteh F, Ribas A, Grilley-Olson JE, Lugowska I, Bonato V, Damore MA, Yang W, Jacobs IA, Bowers M, Li M, Johnson ML

Title

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma.

Journal	Vol	Issue	Date	Pages	Journal Short Title
ESMO open	8	4	2023 Aug	101589	ESMO Open

URL

Abstract Text

Sasanlimab is an antibody to the programmed cell death protein 1 receptor. We report updated data of subcutaneous sasanlimab in non-small-cell lung cancer (NSCLC) and urothelial carcinoma dose expansion cohorts from a first-in-human phase Ib/II study.Patients were ≥18 years of age with NSCLC or urothelial carcinoma, and no prior immunotherapies, who progressed on or were intolerant to systemic therapy, or for whom systemic therapy was refused or unavailable. Patients received subcutaneous sasanlimab at 300 mg every 4 weeks (q4w). Primary objectives were to evaluate safety, tolerability, and clinical efficacy by objective response rate (ORR).Sixty-eight and 38 patients with NSCLC and urothelial carcinoma, respectively, received subcutaneous sasanlimab. Overall, sasanlimab was well tolerated; 13.2% of patients experienced grade ≥3 treatment-related adverse events. Confirmed ORR was 16.4% and 18.4% in the NSCLC and urothelial carcinoma cohorts, respectively. ORR was generally higher in patients with high programmed death-ligand 1 (PD-L1) expression (≥25%) and high tumor mutational burden (TMB; >75%). In the NSCLC and urothelial carcinoma cohorts, median progression-free survival (PFS) was 3.7 and 2.9 months, respectively; corresponding median overall survival (OS) was 14.7 and 10.9 months. Overall, longer median PFS and OS correlated with high PD-L1 expression and high TMB. Longer median PFS and OS were also associated with T-cell inflamed gene signature in the urothelial carcinoma cohort.Subcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 over exp	lung non-small cell carcinoma	predicted - sensitive	PF-06801591	Phase Ib/II	Actionable	In Phase Ib/II trial, PF-06801591 (sasanlimab) therapy was well tolerated in patients with locally advanced or metastatic non-small cell lung cancer and resulted in an objective response rate (ORR) of 16.4% (11/67, 11 partial responses), disease control rate of 56.7% (38/67), median progression-free survival of 3.7 months, and median overall survival of 14.7 months, with an ORR of 36.4% (4/11) in patients with high CD274 (PD-L1) expression (>/=50%) (PMID: 37385154; NCT02573259).	37385154