other material
confidence high
sentiment positive
materiality 0.85
Tempest reports 100% CR rate in 15 CAR-T-naïve patients across two Phase 1 trials of TPST-2003
Tempest Therapeutics, Inc.
- 100% complete response rate (CR) among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 in two Phase 1 trials.
- Favorable safety: no Grade >3 CRS or ICANS observed; 44 patients dosed across three studies to date.
- Median progression-free survival of 23.1 months in rrMM patients, including those with extramedullary disease.
- All 10 evaluable REDEEM-1 patients achieved CR per IMWG criteria; one prior BCMA CAR-T patient did not respond.
- Company plans to meet with FDA later this year to discuss initiating a U.S. registrational study.