Results of a phase 2a, multicenter, open-label, study of RM-1929 photoimmunotherapy (PIT) in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC).

• DOI: 10.1200/jco.2019.37.15_suppl.6014
• Publication Date: 2019-05-27T16:11:05Z
• Authors: David M. Cognetti; Jennifer Maria Jo...; Joseph M. Curry; Frank Mott; Samith Thomas Koc...; Darren McDonald; Mary J. Fidler; Kerstin Stenson; Nilesh R. Vasan; Mohammad Razaq; John P. Campana; Merrill A. Biel; Ann M. Gillenwater
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

6014 Background: Patients with rHNSCC who have failed standard of care poor prognoses and limited therapeutic options. In this study, final results are reported a phase 2a trial photoimmunotherapy (PIT) targeted drug RM-1929, consisting the EGFR-directed antibody cetuximab conjugated to photoactivatable dye (IRDye 700DX). Binding antibody-dye conjugate cancer cells followed by photoactivation nonthermal red light induces selective rapid necrosis cells, minimal damage surrounding tissue. Methods: A 2a, multicenter, open-label, study RM-1929 PIT in patients locoregional, could not be satisfactorily treated surgery, radiation, or platinum chemotherapy was conducted evaluate safety efficacy drug, RM-1929. For each treatment, (690 nm) applied tumors 24 hours post IV infusion drug. Surface illumination administered for superficial interstitial via intratumoral placement fiber optic diffusers deep tumors. Therapeutic response assessed using CT RECIST 1.1 an independent blinded radiologist. Results: Thirty were enrolled. There no dose-limiting toxicities one Grade 1 photosensitivity reaction. Most AEs mild moderate severity 96.7% (29/30) 83.3% (25/30) 2, respectively. 13 (43.3%) had at least SAE. 86% (19/22) SAEs deemed unlikely related including all 3 fatal SAEs. Three possibly/probably treatment (site/oral pain, tumor hemorrhage, airway obstruction). ORR 50% (15/30) 16.7% (5/30) CR 86.7% (26/30) DCR. Median PFS OS will forthcoming. Conclusions: These data indicate that generally well tolerated majority as severity. Preliminary showed favorable rates heavily pre-treated population. global clinical is currently underway. Clinical information: NCT02422979.