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What are the key efficacy endpoints in recent CAR-T trials for multiple myeloma?
Recent CAR-T trials in multiple myeloma primarily evaluate overall response rate (ORR) and duration of response (DOR) as primary endpoints. [1]
- Median progression-free survival (PFS) ranges from 8.8 to 11.3 months across Phase 2 trials. [1] Page 23
- Secondary endpoints include minimal residual disease (MRD) negativity rates and overall survival (OS). [2] Page 45
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The primary safety concerns include cytokine release syndrome (CRS) and neurological toxicities. Grade 3+ CRS occurred in 8-12% of patients across trials. [1]
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Phase 3 enrollment completed in Q3. Primary endpoint data expected Q1 2026. [1]
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Latest FDA guidance on accelerated approval pathways emphasizes surrogate endpoints validation. [1] Page 12
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