Data from Phase 1/2a study of RM-1929 Photoimmunotherapy in Patients with Recurrent Head and Neck Squamous Cell Carcinoma was Published in Head and Neck

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SAN MATEO, Calif., Oct. 27, 2021 /PRNewswire/ — Rakuten Medical, Inc. (Rakuten Medical) announced that data from a phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (RM-1929-101 study, ClinicalTrials.gov Identifier: NCT02422979) was accepted for publication in Head and Neck and published online on October 9^th, 2021.

The manuscript describes the design and results of the 2-part study, which was aimed to elucidate the recommended dose, safety, pharmacokinetics, immunogenicity, and preliminary efficacy of RM-1929 photoimmunotherapy in patients with locoregional rHNSCC.  Part 1* of the study (dose-escalation) determined the recommended drug dose of RM-1929 to be 640 mg/m² with a fixed light dose of 50 J/cm² for superficial tumors and 100 J/cm fiber diffuser length for interstitial tumors.

Among Part 2* participants, 30 patients received RM-1929 photoimmunotherapy, and were included in the safety and treated population. Among Part 2* study participants, 13 (43.3%) patients reported a serious TEAE wherein 3 were considered to be treatment related (tumor pain, oral pain, and airway obstruction). Also, for patients enrolled in Part 2* of the study, the median OS was 9.30 months (95% CI 5.16–16.92 months). Confirmed and unconfirmed objective responses were achieved in 13 (43.3%, 95% CI 25.46%–62.57%) patients, with 4 (13%) patients achieving a complete response (CR) and 9 (30.0%) patients demonstrating a partial response (PR). Disease control [defined as CR, PR, or stable disease (SD)] was observed in 24 (80%, 95% CI 61.43%–92.29%) patients.

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