Imugene’s Blood Cancer Drug Hits 71% Response Rate in Hard-to-Treat BTKi Patients [VIDEO]

Imugene's azer-cel BTKi trial results show a 71% overall response rate across seven evaluable patients in Cohort 3 — including a complete response in Mantle Cell Lymphoma — bringing the full Phase 1b dataset to a 75% ORR across 55 patients.

By Josua Ferreira -

Key Takeaways

  • Four additional patients in Cohort 3 of Imugene's azer-cel Phase 1b trial have reached their Day 28 assessment, with two responding — one Complete Response in MCL and one Partial Response in CLL.
  • The BTKi combination cohort now has seven evaluable patients and a 71% Overall Response Rate, with all patients having previously relapsed on or become refractory to BTKi therapy.
  • Across the full Phase 1b dataset of 55 evaluated patients spanning three cohorts, azer-cel has achieved a combined 75% ORR, with Cohort 2 (CAR T-naïve) leading at 81%.
  • The global BTKi market exceeded US$12.0 billion in 2025, underscoring the commercial scale of the patient population azer-cel's Cohort 3 is targeting.
  • Enrolment remains ongoing across 15 trial sites — 10 in the United States and 5 in Australia — with further clinical updates expected as data matures.
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