KEY TAKEAWAYS
- The phase 3 IKEMA trial aimed to evaluate the efficacy of Isa-Kd in patients with 1q21+ status and related subgroups.
- Patients with 1-3 prior lines of therapy were randomly assigned to Isa-Kd (n=179) or Kd (n=123)
- Isa-Kd demonstrated improved PFS vs. Kd in patients with 1q21+ status, including isolated 1q21+, gain(1q21), or amp(1q21).
- Enhanced responses were observed with Isa-Kd, showing increased rates of ≥VGPR, ≥CR, MRD-, and MRD- ≥CR.
- The results showed that 1q21 abnormalities impact PFS in MM patients. Long-term results from the IKEMA study support Isa-Kd as an effective option for 1q21+ relapsed MM patients.
For the phase 3 IKEMA trial in relapsed MM patients, the researchers aimed to evaluate the efficacy of isatuximab-carfilzomib-dexamethasone (Isa-Kd) in patients with 1q21+ status and related subgroups. The efficacy of Isa-Kd was evaluated in specific subgroups, including patients with 1q21+ status, at a follow-up of 44.2 months.
A total of 179 patients received Isa-Kd, and 123 received Kd as part of their first to third lines of therapy. A prespecified assessment for 1q21+ status was conducted using FISH, defining ≥3 copies as 1q21+, 3 copies as gain(1q21), and ≥4 copies as amp(1q21). In the Isa-Kd and Kd arms, 41.9% and 42.3% of patients had 1q21+ status, respectively. Isa-Kd demonstrated a greater PFS benefit (HR 0.58, 95% CI 0.37–0.92) in patients with 1q21+ status and in those with isolated 1q21+, gain(1q21) or amp(1q21). Responses deepened with Isa-Kd, showing increased rates of ≥VGPR, ≥CR, MRD-, and MRD- ≥CR. The results show that 1q21 abnormalities affect PFS in MM patients. Long-term results support Isa-Kd as an effective option for relapsed MM patients with 1q21+ status.
Source:https://meetings.asco.org/abstracts-presentations/220367
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03275285
Thierry Facon, Philippe Moreau, Ivan Spicka, Kenshi Suzuki, Kwee Yong, Joseph Mikhael, Taro Fukao, Kamlesh Bisht, Nicole Armstrong, Sandrine Macé, Marie-Laure Risse, Thomas G. Martin. J Clin Oncol 41, 2023 (suppl 16; abstr 8029), DOI:10.1200/JCO.2023.41.16_suppl.8029
