Pyxis Oncology’s PYX-201, an antibody-drug conjugate targeting Extradomain-B Fibronectin (EDB+FN), received Fast Track Designation from the FDA for treating recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in patients whose disease progressed after platinum-based chemotherapy and anti-PD-(L)1 antibody treatment. PYX-201 is the first ADC to target EDB+FN, a component of the tumor extracellular matrix highly expressed in various tumor types. This designation facilitates expedited development and review of PYX-201.
This FDA decision is crucial due to the high unmet need in R/M HNSCC. Nearly half of head and neck cancer cases become recurrent or metastatic, resulting in a median overall survival of less than a year after initial treatment. Furthermore, the incidence of HNSCC is projected to increase significantly by 2030, driven by factors including tobacco and alcohol use, HPV infections, and environmental factors. The Fast Track Designation for PYX-201 offers hope for improved outcomes in this difficult-to-treat cancer.
PYX-201 is currently being evaluated in two clinical trials. The PYX-201-101 trial is investigating PYX-201 as a monotherapy in R/M HNSCC patients. The PYX-201-102 trial is assessing PYX-201 in combination with pembrolizumab (Keytruda) in patients with R/M HNSCC and other advanced solid tumors. This combination trial is part of a collaboration with Merck.
This Fast Track Designation expedites PYX-201’s development, potentially leading to quicker access for patients facing a challenging prognosis with R/M HNSCC. The ongoing clinical trials will provide crucial data on PYX-201’s efficacy and safety, potentially shaping the treatment landscape for this aggressive form of cancer. Positive results could establish PYX-201 as a valuable therapeutic option, particularly for patients who have progressed after standard treatments. This progress may also stimulate further research into targeting the tumor microenvironment, particularly EDB+FN, as a therapeutic strategy for various cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
