Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma

• DOI: 10.1002/hed.26885
• Publication Date: 2021-10-10T15:07:07Z
• Authors: David M. Cognetti; Jennifer M. Johnson; Joseph M. Curry; Samith T. Kochupa...; Darren McDonald; Frank Mott; Mary J. Fidler; Kerstin Stenson; Nilesh R. Vasan; Mohammad A. Razaq; John Campana; Patrick Ha; Grace Mann; Kosuke Ishida; Miguel Garcia‐Guzman; Merrill Biel; Ann M. Gillenwater
• Keywords: Squamous Cell Carcinoma of Head and Neck; Cetuximab; Original Articles; Phototherapy; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Head and Neck Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Humans; Immunotherapy; Neoplasm Recurrence, Local

Abstract Background Recurrent head and neck squamous cell carcinoma (rHNSCC) represents a significant global health burden with an unmet medical need. In this study we determined the safety efficacy of RM‐1929 photoimmunotherapy in patients heavily pretreated rHNSCC. Methods (anti‐EGFR–IR700 dye conjugate) was infused, followed by tumor illumination. We evaluated safety, response, pharmacokinetics. Results Nine were enrolled Part 1 (dose‐finding) 30 2 (safety efficacy). No dose‐limiting toxicities experienced 1; 640 mg/m fixed light dose (50 J/cm or 100 J/cm) recommended for 2. Adverse events (AEs) mostly mild to moderate but 19 (63.3%) had AE ≥Grade 3, including 3 (10.0%) serious AEs leading death (not treatment related). Efficacy 2: unconfirmed objective response rate (ORR) 43.3% (95% CI 25.46%–62.57%); confirmed ORR 26.7% 12.28%–45.89%); median overall survival 9.30 months 5.16–16.92 months). Conclusions Treatment well tolerated. Responses following rHNSCC clinically meaningful warrant further investigation. Clinical Trial Information NCT02422979.