On October 27, 2021 Rakuten Medical, Inc. (Rakuten Medical) reported 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 9th, 2021 (Press release, Rakuten Medical, OCT 27, 2021, View Source [SID1234592063]).
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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.
The full text article is available at View Source
*Part 1: Phase 1 study part (safety and dose-finding) / Part 2: Phase 2a study part (safety and preliminary anticancer activity; patients were treated with up to 4 cycles of RM-1929 photoimmunotherapy)
**RM-1929 and ASP-1929 are analogous. Extensive physiochemical studies show that they have comparable physical and chemical properties.