NovaBridge Presents Positive Ragistomig Phase 1 Dose Expansion Data at ESMO-IO

Core Insights - NovaBridge Biosciences announced new data from the Phase 1 dosing study of ragistomig, a bispecific 4-1BB X PD-L1 antibody, showing consistent antitumor activity and improved safety profile with a new dosing schedule [1][2][3] Group 1: Study Results - The new Q6W dosing schedule demonstrated a disease control rate (DCR) of 58.8%, comparable to the 64.3% DCR observed with the previous Q2W schedule [7] - Only 5% of patients experienced Grade ≥3 liver function test (LFT) elevations with the Q6W regimen, compared to 40% with the Q2W regimen [13] - The study achieved its objective of extending the therapeutic window, supporting the advancement of ragistomig into combination studies [2][3] Group 2: Immunological Data - The Q6W dosing showed positive immunological data, including expansion of effector memory and CD8+ T cells, indicating durable immune engagement [7][13] - The study reported no cases of cytokine release syndrome (CRS) with either dosing schedule, highlighting the favorable safety profile [7][13] Group 3: Patient Characteristics - The study included 20 heavily pre-treated subjects receiving 3 mg/kg Q6W ragistomig, with 100% previously treated with immuno-oncology therapies [12] - Among the 17 evaluable patients on the Q6W regimen, the objective response rate was 11.8%, while the Q2W regimen had a 28.6% response rate [9] Group 4: Future Directions - The ongoing evaluation of the 5 mg/kg Q6W dosing cohort and future combination studies is anticipated to further assess the efficacy of ragistomig [8]