Reference Detail

Ref Type

abstract

PMID

Authors

M. Oliva, S. Ochsenreither, C. Le Tourneau, S. Champiat, R. Saleh, K. Burkitt, L. Nabell, N. Steeghs, A. Spreafico, A.R. Minchom, A. Patnaik, J.A. Call, E. Fontana, N. Kotecki, E. Garralda, A. Zivi, J.W. Riess, S. Gupta, R. Zhang, M. Gillison

Title

607O Interim results of a phase I study of SGN-PDL1V (PF-08046054) in patients with PDL1-expressing solid tumors

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	35	Supplemental 2	September 2024

URL

https://www.annalsofoncology.org/article/S0923-7534(24)02193-8/fulltext

Abstract Text

Background To assess the safety/tolerability and antitumor activity of SGN-PDL1V, a novel investigational antibody-drug conjugate that delivers monomethyl auristatin E to cells that express Programmed Cell Death Ligand 1 (PDL1). Methods SGNPDL1V-001 (NCT05208762) is a phase 1 study enrolling patients (pts) with relapsed/refractory PDL1-expressing solid tumors (non-small cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], triple negative breast cancer [TNBC], and esophageal cancer [EC]) who progressed on standard of care therapies. Measurable disease per RECIST v1.1, and ECOG PS of ≤1 are required. In dose escalation, pts received doses of SGN-PDL1V from 0.5-1.75 mg/kg on days 1, and 8 of every 21-day cycle using adjusted ideal body weight. The primary objectives of this study are safety/tolerability and pharmacokinetics with antitumor activity as a secondary objective. Results As of March 6, 2024, 55 pts were dosed with a median age of 60 years (range 24–72); 54.5% were male, 72.7% had ECOG PS 1, 54.5% had HNSCC, 29.1% NSCLC, 14.5% TNBC, and 1.8% EC. No dose-limiting toxicities (DLTs) were seen; 1.75 mg/kg was the highest dose evaluated. Peripheral sensory neuropathy (21.8%), asthenia (18.2%), fatigue (18.2%), and nausea (18.2%), were the most common treatment-related adverse events (TRAEs); the majority were grade 1-2 in severity. No immune-related TRAEs were seen. Overall grade ≥ 3 TRAEs was 30.9%. The most common grade ≥ 3 TRAE was decreased neutrophil count (7.3%). Treatment discontinuation due to treatment-emergent AEs was seen in 14.5% of pts. The investigator-assessed objective response rate (ORR) across all doses and tumor types was 27.3% (12.7% confirmed), and the median duration of confirmed responses was 7.9 months. Objective responses were observed starting at 1.25 mg/kg and independent of PDL1 expression. Conclusions Single agent SGN-PDL1V was generally well tolerated with a manageable safety profile. Encouraging preliminary antitumor activity was observed. Enrollment in the phase 1 study continues.

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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 positive	Advanced Solid Tumor	predicted - sensitive	SGN-PDL1V	Phase I	Actionable	In a Phase I trial, SGN-PDL1V treatment demonstrated manageable safety and resulted in an objective response rate of 27.3% and a median duration of response of 7.9 months in patients with CD274-positive advanced solid tumors (n=55), including non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and esophageal cancer (Ann Oncol (2024) 35 (suppl_2): S486;NCT05208762).	detail...