Source – Rakuten Medical
Promising early results have been observed with ASP-1929, in combination with anti-PD-1 therapy, for patients with locoregional/metastatic head and neck squamous cell carcinoma (HNSCC). These findings were presented at the American Head and Neck Society’s (AHNS) 11th International Conference on Head and Neck Cancer (AHNS 2023) on July 10, 2023.
The Phase Ib/II study (ASP-1929-181; NCT04305795) included 19 patients in cohort 1, who received photoimmunotherapy using ASP-1929 along with pembrolizumab (Keytruda). The combination demonstrated an objective response rate (ORR) of 29.4% (95% CI, 10.3%-56.0%). Of the 5 responders, 17.6% achieved a complete response, and 11.8% showed partial responses. The 18-month overall survival (OS) rate was 53.5% (95% CI, 18.5%-79.3%).
Furthermore, the combination of ASP-1929 and anti-EGFR therapy was well-tolerated in the patients under investigation. The study, focusing on ASP-1929 in recurrent or metastatic HNSCC, is ongoing.
Patients with advanced head and neck cancer face limited treatment options and experience low survival rates and high locoregional recurrence. PD-1 therapy, which is utilized for various tumor types, including head and neck cancer, has shown promising preliminary results in this study. The researchers believe that further investigation could establish this combination as an innovative treatment for recurrent head and neck cancer. Ann M. Gillenwater, MD, professor at The University of Texas MD Anderson Cancer Center, emphasized the potential benefits of targeting both EGFR-positive tumors and PD-1 blockade, leading to an improved and durable antitumor immune response compared to monotherapy alone.
The Phase Ib/II study will assess approximately 74 patients with advanced solid tumors, including HNSCC. The study’s three cohorts will explore different treatment approaches for first-line and second-line HNSCC using ASP-1929 in combination with pembrolizumab or cemiplimab (Libtayo). The study’s primary endpoints include treatment-emergent adverse events (TEAEs) and serious TEAEs, as well as ORR in each cohort. Secondary endpoints will evaluate OS, progression-free survival, and duration of response.
To be eligible for the study, patients must have confirmed HNSCC, accessible disease for light illumination, measurable disease, good organ function, and an ECOG performance status of 0 or 1. Prior systemic therapy in the recurrent/metastatic setting should have been completed at least 6 months before the study as part of a multimodal regimen for locally advanced disease. Certain exclusion criteria include prior anti-PD-1/anti-PD-L1 therapy, recent radiation therapy, allogeneic transplant, major surgery, active central nervous system involvement, active infection requiring systemic treatment, and other comorbidities that could interfere with study treatment.
In summary, the combination of ASP-1929 with anti-PD-1 therapy shows promise as a potential new treatment option for patients with locoregional/metastatic HNSCC. Further investigation and evaluation are needed to establish its effectiveness and safety in this patient population.
“Patients with advanced head and neck cancer lack many treatment options and experience overall low survival and high locoregional recurrence. PD-1 therapy is used to treat various tumor types including head and neck cancer. The preliminary results seen in this study warrant further study to evaluate its potential as a new innovative treatment for recurrent head and neck cancer. Targeting both EGFR+ tumors and PD-1 blockade, the antitumor immune response is anticipated to result in improved tumor shrinkage that is durable compared to either monotherapy alone.”
– Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center
