Sasanlimab Clinical Naked monospecific

Antibody Information

Entry ID	1100
INN	Sasanlimab
Status	Clinical
Drug code(s)	PF-06801591
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	PD-1
Indications of clinical studies	Clear cell renal cell carcinoma, Non-small cell lung cancer, Non-muscle Invasive Bladder Cancer, melanoma, SCCHN, ovarian carcinoma, sarcoma, or relapsed or refractory cHL (one Phase 1 study), prostate cancer
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	December 15, 2015
Start of Phase 2
Start of Phase 3	December 30, 2019
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Pfizer
Licensee/Partner	None
Comments about company or candidate	Jan 2025: Pfizer Inc. announced positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer. Pfizer plans to discuss these data with global health authorities to support potential regulatory filings. Phase 3 in Pfizer pipeline dated Oct 2024. NCT06218069 Phase 2/3 in NSCLC due to start in Aug 2024. NCT04165317 Phase 3 study in Non-muscle Invasive Bladder Cancer started in Dec 2019, before Phase 2 study; active not recruiting as of April 19, 2023; primary completion date is in June 2024. NCT04181788 Phase 2 study due to start in Feb 2020 not yet recruiting. Sep 30, 2019: ESMO presentation (1275P) Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC); presenter Cho BC. Listed in Pfizer pipeline dated July 29, 2019. Two Phase 1 studies still recruiting as of Sep 2018. NCT02573259 Phase 1 study in MELANOMA; SCHNC; OVCA; SARCOMA; HODGKIN LYMPHOMA recruiting as of Feb 29, 2016. PF-06801591 is under development for the treatment of cancer. U273The drug candidate is a monoclonal antibody which targets programmed cell death protein1 (PD-1). Also being evaluated as part of a Vaccine-based Immunotherapy Regimen in a Phase 1 study.
Full address of company	66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact

Description/comment

Immune checkpoint target

Additional information

Anticipated events	Possible BLA in 2025?
Factor(s) contributing to discontinuation	None