A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma

• DOI: 10.1007/s10147-021-01960-6
• Publication Date: 2021-06-24T12:02:40Z
• Authors: Makoto Tahara; Susumu Okano; Tomohiro Enokida; Yuri Ueda; Takao Fujisawa; Takeshi Shinozaki; Toshifumi Tomioka; Wataru Okano; Merrill A. Biel; Kosuke Ishida; Ryuichi Hayashi
• Keywords: 0301 basic medicine; 03 medical and health sciences; Japan; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Combined Chemotherapy Protocols; Cetuximab; Humans; Original Article; Immunotherapy; Neoplasm Recurrence, Local; 3. Good health

Abstract Background To determine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of a single cycle RM-1929 photoimmunotherapy, an anti-EGFR antibody cetuximab conjugated with light-activatable dye (IRDye ® 700DX), in Japanese patients recurrent head neck squamous cell carcinoma (rHNSCC). Methods Patients received fixed dose (640 mg/m 2 ) light treatment (50 J/cm for superficial illumination; 100 fiber diffuser length interstitial illumination). Safety, tumor response (modified RECIST v1.1 by central radiology review), were evaluated. Results Three enrolled who had failed ≥ 3 prior lines therapy including radiation, chemotherapy, cetuximab, immunotherapy. Target lesions were: submental lesion; right cervical node lesion oropharynx external auditory canal lesion. All experienced 1 treatment-emergent adverse event (TEAE), but none considered dose-limiting. TEAEs mild to moderate severity except one grade application-site pain, which was transient, resolved without sequelae within 24 h, did not affect study administration. Thirteen 17 reported possibly or probably related treatment. patient reports pain localized edema deemed Objective observed two (both partial responses). The third disease progression. concentrations pharmacokinetic parameters similar all patients. No tested positive anti-drug antibodies. Conclusions photoimmunotherapy showed manageable safety profile rHNSCC. Tumor these heavily pre-treated clinically meaningful warrants further investigation. Clinical trial registration registered registry clinical trials as jRCT2031200133.