Meta Category: Healthcare

Key Highlights

  • Four additional Cohort 3 patients reached their Day 28 assessment.
  • One mantle cell lymphoma patient achieved a complete response and one chronic lymphocytic leukaemia patient achieved a partial response.
  • The BTKi combination cohort now has seven evaluable patients and a reported 71% overall response rate on early numbers.
  • Enrolment continues across 10 US and five Australian sites.

Imugene Limited (ASX:IMU) has added four Day 28 assessments to the BTK inhibitor combination cohort of its ongoing Phase 1b azer-cel study. Two of the newly evaluated patients responded: one patient with mantle cell lymphoma achieved a complete response and one patient with chronic lymphocytic leukaemia recorded a partial response. The update takes Cohort 3 to seven evaluable patients, all of whom had previously received and progressed on BTKi therapy.

Four New Assessments Broaden the Early Dataset

Alongside the complete and partial responses, one patient with Richter’s Transformation had stable disease and another mantle cell lymphoma patient had progressive disease. The cohort combines azer-cel, an allogeneic CD19-directed CAR T therapy, with continuation of a BTK inhibitor in patients whose disease had already progressed on BTKi treatment.

Early Cohort Response Rate Stands at 71%

Across the seven evaluable patients in the BTKi combination cohort, Imugene reports a 71% overall response rate on early numbers. Across the broader Phase 1b study, the company reports a 75% overall response rate across the total evaluated population, with response rates varying by cohort. These percentages come from relatively small early-stage groups and may change as enrolment expands.

Multi-Centre Recruitment Continues

Patient enrolment remains underway across 10 sites in the United States and five in Australia. The study is designed to assess azer-cel across different patient settings, including heavily pre-treated individuals. Additional patients and longer follow-up will provide more information on response durability, safety and whether the early activity persists in a larger dataset.

Small Numbers Require Caution

Phase 1b studies are primarily early clinical investigations, and seven evaluable patients in Cohort 3 remain a limited sample. Complete and partial responses are clinically relevant observations, but later assessments can change response status. Safety, durability, Manufacturing consistency and subsequent regulatory requirements remain important uncertainties for an investigational CAR T program.

Forward-Looking Summary

Imugene’s next read-through will come from continued enrolment and follow-up, with a larger patient base needed to clarify response durability and the profile of the BTKi combination strategy.