Tempest's Dual-Targeting CAR-T Shows 100% Response Rate in Key Trials
Event summary
- Tempest's TPST-2003 achieved 100% complete response rate in 15 CAR-T-naïve patients across two Phase 1 trials (REDEEM-1 and POEMS-1).
- Favorable safety profile with no Grade >3 CRS or ICANS observed in REDEEM-1 trial for relapsed/refractory multiple myeloma.
- 44 patients treated to date across three studies, representing one of the largest datasets for a CD19/BCMA dual-targeting CAR-T therapy.
- Median progression-free survival of 23.1 months in REDEEM-1, positioning TPST-2003 as a potential class-leading therapy if replicated in registrational trials.
- Tempest plans to meet with FDA to discuss initiating a U.S. registrational study later in 2026.
The big picture
Tempest's data reinforces the potential of dual-targeting CAR-T architectures to address tumor heterogeneity and antigen escape in relapsed/refractory multiple myeloma. The favorable safety and efficacy profile positions TPST-2003 as a potential disruptor in a market dominated by single-targeting therapies. Success in registrational trials could validate Tempest's approach and attract partnerships or acquisitions, given the high unmet need in this patient population.
What we're watching
- Regulatory Pathway
- Whether Tempest can secure FDA agreement to initiate a U.S. registrational study later this year, accelerating TPST-2003's path to market.
- Clinical Validation
- How the 23.1-month median progression-free survival holds up in larger, registrational trials, particularly in patients with extramedullary disease.
- Competitive Positioning
- The pace at which Tempest can differentiate TPST-2003 from first-generation single-targeting CAR-T therapies in the relapsed/refractory multiple myeloma space.
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