Pfizer's (PFE.US) new PD-L1-targeting ADC drug has been approved for clinical trials in China, aiming to treat advanced solid tumors.

On March 10, the National Medical Products Administration's Center for Drug Evaluation (CDE) officially announced that Seagen, a subsidiary of Pfizer (PFE.US), had received a clinical trial approval for its first-in-class new drug PF-08046054 (powder for injection), which is intended to treat metastatic or unresectable advanced solid tumors. According to public information, this is a potential "first-in-class" PD-L1-targeting antibody-drug conjugate (ADC) being developed by Pfizer.According to Pfizer's public information, PF-08046054 (also known as SGN-PDL1V, PDL1V) is an ADC targeting PD-L1, composed of an anti-PD-L1 antibody, a linker, and the microtubule-disrupting agent MMAE (monomethyl auristatin E), which can exert antitumor activity through direct cytotoxicity, bystander killing, and immunogenic cell death. In preclinical studies, this ADC product also showed antitumor activity in animal models with low or heterogeneous PD-L1 expression.At the 2024 European Society for Medical Oncology (ESMO) Congress, researchers presented the interim results of the Phase 1 clinical trial (SGNPDL1V-001 study) of PF-08046054.As of March 6, 2024, 55 patients were treated, 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 (TRAEs) were peripheral sensory neuropathy, fatigue, asthenia, and nausea, with most patients experiencing a severity of 1-2. In terms of efficacy, the objective response rate (ORR) was 27.3% (confirmed ORR was 12.7%) as assessed by investigators, with a median duration of confirmed response of 7.9 months. Objective responses were observed starting at the 1.25 mg/kg dose, regardless of PD-L1 expression.Reference(s):- CDE's official website: https://www.nmpa.gov.cn/ [Accessed March 10, 2024]- Pfizer's public information: https://www.pfizer.com/ [Accessed March 10, 2024]- ESMO Congress 2024: https://www.esmo.org/ [Accessed March 10, 2024]