At ASH 2023 this year, Dr. Slavisa Ninkovic & Prof. Hang Quach presented the results of the primary analysis of the I-RIL study (AMaRC 18-02) at ASH 2023. It was shown that in transplant-ineligible, newly-diagnosed (TI NDMM) patients who did not achieve PR by the end of cycle 4 on lenalidomide/dex (Rd), 93% (14/15 evaluable subjects for primary outcome) achieved ≥PR (incl. 9 ≥VGPR) with the addition of isatuximab.
There are also some key preliminary estimates:
- Response rates: ≥VGPR 64.2%; ≥CR 28.4%,
- 2-yr PFS 64.3%
- 2-yr OS 73.3%
Safety overview of primary endpoint cohort:
- Grade ≥3 neutropenia: 40%
- Fever: 13.3%
This demonstrates that a response-adapted approach for TI NDMM using Isatuximab rescue is safe and very effective for poor responders to Rd! We will be working towards the publication of the full analysis of I-RIL in 2024.