Pfizer (PFE.US) PD-L1 Targeting ADC New Drug Approved Clinically Proposed to Treat Advanced Solid Tumors in China

The Zhitong Finance App learned that on March 10, the official website of the China Drug Administration's Drug Evaluation Center (CDE) recently announced that the Class 1 new drug PF-08046054 (freeze-dried powder needle for injection) declared by Seagen under Pfizer (PFE.US) has obtained implied clinical trial approval to develop treatment for metastatic or unresectable advanced solid tumors. According to public information, this is a potential “first-in-class” PD-L1 targeted antibody conjugate drug (ADC) being developed by Pfizer.

Screenshot source: CDE official website

According to Pfizer's public information, PF-08046054 (also known as SGN-PDL1V, PDL1V) is an ADC targeting PD-L1. It is composed of anti-PD-L1 antibodies, connectors, and the microtubule disruptor MMAE (monomethyl auristatin E). It can exert anti-tumor activity through direct cytotoxicity, bystander killing, and immunogenic cell death. In preclinical studies, this ADC product also showed anticancer activity in animal models with low PD-L1 expression or high expression heterogeneity.

At the 2024 European Society of Medical Oncology (ESMO) conference, researchers announced the interim phase 1 clinical results of PF-08046054 (SGNPDL1V-001 study).

As of March 6, 2024, 55 patients had received treatment, with a median age of 60 years (range 24-72 years). No dose-limiting toxicity (DLT) was observed; 1.75 mg/kg was the highest dose evaluated. The most common treatment-related adverse events (TREs) are peripheral sensory neuropathy, fatigue, and nausea, with severity levels 1-2 in most patients. In terms of efficacy, the investigators assessed an objective response rate (ORR) of 27.3% (determined ORR of 12.7%) for all doses and tumor types, and the median duration of determined response was 7.9 months. An objective response was observed starting at the 1.25 mg/kg dose and was unrelated to PD-L1 expression.