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

Autor: Nilesh R. Vasan, Merrill A. Biel, Jennifer Johnson, Joseph Curry, Samith T. Kochuparambil, Darren McDonald, Mary J. Fidler, Frank E. Mott, Mohammad Razaq, Miguel Garcia-Guzman, Kosuke Ishida, Grace Mann, David Cognetti, Ann M. Gillenwater, John Campana, Kerstin M. Stenson, Patrick K. Ha
Rok vydání: 2021
Předmět:
Zdroj: Head & Neck. 43:3875-3887
ISSN: 1097-0347
1043-3074
Popis: 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 and efficacy of RM-1929 photoimmunotherapy in patients with heavily pretreated rHNSCC. Methods RM-1929 (anti-EGFR-IR700 dye conjugate) was infused, followed by tumor illumination. We evaluated safety, tumor response, and pharmacokinetics. Results Nine patients were enrolled in Part 1 (dose-finding) and 30 patients in Part 2 (safety and efficacy). No dose-limiting toxicities were experienced in Part 1; 640 mg/m2 with fixed light dose (50 J/cm2 or 100 J/cm) was recommended for Part 2. Adverse events (AEs) in Part 2 were mostly mild to moderate but 19 (63.3%) patients had AE ≥Grade 3, including 3 (10.0%) with serious AEs leading to death (not treatment related). Efficacy in Part 2: unconfirmed objective response rate (ORR) 43.3% (95% CI 25.46%-62.57%); confirmed ORR 26.7% (95% CI 12.28%-45.89%); median overall survival 9.30 months (95% CI 5.16-16.92 months). Conclusions Treatment was well tolerated. Responses and survival following RM-1929 photoimmunotherapy in heavily pretreated patients with rHNSCC were clinically meaningful and warrant further investigation. Clinical trial information NCT02422979.
Databáze: OpenAIRE
Externí odkaz: