Pfizer's Investigational Cancer Drug Combo Shows Early Promise

Pfizer has presented promising interim results from a Phase I study evaluating the combination of PF-08046054, a novel antibody-drug conjugate (ADC) targeting PD-L1, with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

As of the data cutoff, 14 patients had been dosed. Among the 14 response-evaluable patients, the overall response rate (ORR) was 50%, with a complete response (CR) rate of 21.4%. The median duration of response had not yet been reached.

PF-08046054 is designed to selectively deliver the cytotoxic payload monomethyl auristatin E (MMAE) to cells expressing PD-L1. The combination with pembrolizumab aims to enhance anti-tumor immune responses. The most frequent treatment-related adverse events (TRAEs) for PF-08046054 included fatigue and nausea (50% each), followed by peripheral sensory neuropathy. For pembrolizumab, common TRAEs included fatigue and diarrhea.

No dose-limiting toxicities (DLTs) were observed. Grade ≥3 TRAEs for either agent were infrequent. The combination was generally well-tolerated, and these early findings support continued clinical development for the treatment of advanced HNSCC.