Clinical TrialMay 6, 2026, 07:03 AM
Tempest Therapeutics' TPST-2003 achieves 100% CR in 15 patients
AI Summary
Tempest Therapeutics presented updated positive clinical data for its lead dual-targeting CAR-T therapy, TPST-2003, at the ISCT Scientific Annual Meeting. The therapy achieved a 100% complete response rate among all 15 CAR-T-naïve efficacy evaluable patients across two Phase 1 trials (REDEEM-1 and POEMS-1) for relapsed/refractory multiple myeloma and POEMS syndrome, respectively. The data also showed a favorable safety profile and supports the company's plan to meet with the FDA to discuss initiating a U.S. registrational study later this year.
Key Highlights
- TPST-2003 achieved a 100% complete response rate in 15 CAR-T-naïve patients across two Phase 1 trials.
- REDEEM-1 trial showed 100% CR in 10/10 CAR-T-naïve rrMM patients with favorable safety.
- POEMS-1 trial showed 100% CRVEGF in 5/5 evaluable patients for POEMS syndrome.
- A total of 44 patients have been treated with TPST-2003 across three studies to date.
- Median progression-free survival of 23.1 months observed, potentially class-leading for rrMM.
- Company plans to meet with FDA to discuss initiating a U.S. registrational study later this year.