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GPRC5D/BCMA/CD3 三抗
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山西证券研究早观点-20251223
Shanxi Securities· 2025-12-23 00:32
Core Insights - The report highlights the promising potential of GPRC5D/BCMA/CD3 tri-antibody therapy for relapsed/refractory multiple myeloma (RRMM), showcasing an overall response rate (ORR) of 100% and a 12-month progression-free survival (PFS) rate of 96.3% [4]. Market Trends - The report notes that multiple myeloma (MM) is the second most common hematological malignancy, with over 300,000 new cases globally each year. Most MM cases progress to RRMM, indicating a significant unmet medical need after standard treatments fail [4]. Industry Commentary - GPRC5D and BCMA are highly expressed on the surface of malignant plasma cells, making them attractive targets for immunotherapy in MM. The JNJ-79635322 tri-antibody is the first to enter Phase III clinical trials for RRMM, targeting BCMA, GPRC5D, and CD3 to precisely modulate immune signaling [4]. - In early clinical trials, JNJ-79635322 demonstrated superior survival benefits, with a 12-month PFS rate of 96.3% in patients who had not previously received BCMA/GPRC5D therapy. The overall response rate (ORR) for the entire population was 73% [4]. - IBI3003, another candidate, showed an ORR of 83.3% in patients who had undergone at least four prior lines of treatment, indicating its efficacy in heavily pre-treated RRMM patients [4]. Clinical Data - JNJ-79635322 exhibited an ORR of 100% in a subgroup of patients who had not received prior BCMA/GPRC5D therapy, with a median follow-up of 15 months. Adverse events included infections (80.6%) and cytokine release syndrome (CRS) [4]. - IBI3003 demonstrated an ORR of 77.8% in patients previously treated with BCMA and/or GPRC5D therapies, with a good safety profile [4].