Tempest’s TPST-2003 Yields 100% CR in 15 Patients, 23.1-Month PFS
Tempest Therapeutics reported a 100% complete response rate in all 15 CAR-T-naïve patients treated with TPST-2003 across REDEEM-1 and POEMS-1 Phase 1 trials, including 10 rrMM patients and five POEMS syndrome patients, with no Grade >3 CRS or ICANS observed. Across 44 treated subjects, median progression-free survival reached 23.1 months.
1. Clinical Efficacy in Phase 1 Trials
TPST-2003 achieved a 100% complete response rate in all 15 CAR-T-naïve efficacy-evaluable patients across REDEEM-1 (10 relapsed/refractory multiple myeloma patients) and POEMS-1 (five POEMS syndrome patients) trials. Among 29 CAR-T-naïve patients with measurable disease at baseline, including 18 with extramedullary disease, the overall response rate was 100%.
2. Safety and Tolerability Profile
No Grade >3 cytokine release syndrome or ICANS events were observed in the REDEEM-1 trial, and no dose-limiting toxicities emerged across the 44 patients treated to date. The favorable safety profile supports the parallel dual-targeting CAR architecture’s tolerability.
3. Development Outlook and Next Steps
With a median progression-free survival of 23.1 months, TPST-2003 could position itself as a class-leading therapy for relapsed/refractory multiple myeloma. Tempest plans to meet with the FDA later this year to discuss initiation of a U.S. registrational study based on these data.