Pfizer Initiates First-in-China Phase I Trial of PF-08046054, One of Only Two PD-L1 ADCs in Global Clinical Development

May 13, 2025 11:09 CST Updated 11:09

Pfizer

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On May 12, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Pfizer had initiated a Phase I clinical trial of PF-08046054 for patients with solid tumors in China.

PF-08046054（SGN-PDL1V）An ADC targeting PD-L1 that Pfizer acquired from Seagen 。Currently, there are only 2 PD-L1 ADCs globally that have entered the clinical stage.

Screenshot source:Drug Clinical Trial Registration and Information Disclosure Platform

This Phase Ⅰ clinical trial aims to evaluate PF-08046054 asMonotherapy for Advanced Solid Malignant TumorsSubject, and asCombined TherapyFor metastatic or unresectableHead and NeckSquamous Cell Carcinoma（HNSCC）OrNon-Small Cell Lung Cancer（NSCLC）The safety, tolerability, PK, and antitumor activity of the subjects. The primary endpoint of the study is safety, and the secondary endpoint is efficacy.

At the 2014 ESMO, Pfizer first announced the Phase I clinical data of PF-08046054. The study(NCT05208762) Recruited Relapsed/RefractoryPD-L1 Expressing Solid TumorsPatients, includingNSCLC、HNSCCTriple-Negative Breast Cancer（TNBC）Esophageal Cancer（EC）, these patients experienced progression after standard treatment. The study'sThe primary endpoint is safety/tolerability and pharmacokinetics, and the secondary endpoint is antitumor activity.

As of March 6, 2024A total of 55 patients received treatment, 72.7% of the patients had an ECOG PS of 1, and 54.5% of the patients had squamous cell carcinoma of the head and neck., 29.1% of patients had non-small cell lung cancer, 14.5% of patients had triple-negative breast cancer., 1.8% of patients have esophageal cancer。

All doses and tumor types assessed by the investigatorORR was 27.3% (cORR 12.7%)，The confirmed mDOR was 7.9 months.Objective responses were observed starting from 1.25 mg/kg and were independent of PD-L1 expression.

In terms of safety, no dose-limiting toxicity was observed. (DLT), 1.75 mg/kg was the highest dose evaluated. No immune-related TRAEs were observed. The overall incidence of ≥ grade 3 TRAEs was 30.9%. Treatment was discontinued in 14.5% of patients due to treatment-emergent AEs.

Insight database shows,Globally, there are currently 2 ADCs targeting PD-L1 that have entered the clinical stage.. In addition to Pfizer'sPF-08046054, another one isYilian Biologics/Henlius's HLX43, which is currently in Phase II clinical trials. In addition, three dual-target ADCs targeting PD-L1 have entered clinical trials, coming from Innovent, DualityBio, and Alphamab Oncology respectively.

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