Fortvita Biologics, a member of Innovent Biologics leading clinical development of IBI3003 outside China, joined Innovent at the 23rd International Myeloma Society (IMS) Annual Meeting. At the congress, Innovent announced updated Phase 1 clinical data for IBI3003, a novel trispecific antibody targeting G protein-coupled receptor class C group 5 member D (GPRC5D), B-cell maturation antigen (BCMA), and cluster of differentiation 3 (CD3), in patients with relapsed or refractory multiple myeloma (R/R MM) in an oral presentation.
Based on an integrated analysis of the efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) data from dose optimization cohorts receiving IBI3003 at 120, 360, and 540 μg/kg in the Phase 1 study, the recommended Phase 2 dose (RP2D) was determined to be 360 μg/kg.
A total of 26 patients received IBI3003 at 360 μg/kg, with a median follow-up duration of 7.57 months. Median progression-free survival (mPFS) was not reached.
- The overall response rate (ORR) was 84.6%, including 11 cases of stringent complete response (sCR), 4 cases of very good partial response (VGPR), and 7 cases of partial response (PR). The ORR was 94.7% among 19 patients who had received 2 to 4 prior lines of therapy, 87.5% among 8 patients with non-bone-related extramedullary disease (EMD), and 92.3% among 13 patients without EMD.
- The median time to first response was 0.99 months (range: 0.9-8.3 months), the median time to first response of ≥VGPR was 1.87 months (range: 0.9-4.6 months), and the median time to first response of ≥CR was 2.79 months (range: 0.9-9.2 months).
- Among patients who achieved CR or better as assessed by central laboratory next-generation sequencing (NGS) testing, the minimal residual disease (MRD) negativity rate was 100% (n=8). Three patients achieved MRD negativity after receiving only one treatment cycle.
For full results, including safety data, read Innovent’s press release.
ABOUT FORTVITA
Fortvita Biologics is a clinical-stage biopharmaceutical company headquartered in the San Francisco Bay Area, with global development and commercial operations capabilities across Asia, Europe, Australia, and the United States. As a member of Innovent Biologics, Fortvita draws on Innovent’s proven discovery, development, and manufacturing capabilities. Its pipeline reflects a strong foundation in oncology that is expanding into cardiovascular and metabolic, autoimmune, and ophthalmic diseases.
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