KEY TAKEAWAYS
- The phase 3 ICARIA-MM and IKEMA clinical trials evaluated the efficacy of Isa combined with P and (d; Isa-Pd or K in patients with relapsed and refractory multiple myeloma.
- The primary aim was to determine the efficacy of Isa-Pd/Isa-Kd in patients with soft-tissue plasmacytomas, a rare manifestation of multiple myeloma.
- Central radiology and central laboratory assessments were used to evaluate the efficacy of Isa-Pd/Isa-Kd in patients with soft-tissue plasmacytomas.
- The combination of Isa-Pd/Isa-Kd resulted in a significant improvement in PFS compared to Pd/Kd alone, as well as an improvement in overall response rate and excellent partial response or better rate.
- Patients with soft-tissue plasmacytomas who received Isa-Pd/Isa-Kd had similar median PFS compared with those without soft-tissue plasmacytomas.
- The combination of Isa-Pd/Isa-Kd is a potential new treatment option for patients with relapsed and refractory multiple myeloma.
The Phase 3 ICARIA-MM (NCT02990338) and IKEMA (NCT03275285) clinical trials have shown that the combination of isatuximab (Isa) with pomalidomide (P) and dexamethasone (d; Isa-Pd) or carfilzomib (K) and d (Isa-Kd) has resulted in a significant improvement in progression-free survival (PFS) compared to Pd or Kd alone, in patients diagnosed with relapsed and refractory multiple myeloma. Researchers conducted a post hoc analysis of patients diagnosed with soft-tissue plasmacytomas in this study. The efficacy of Isa-Pd/Isa-Kd was evaluated through central radiology and laboratory assessments. Considering the low prevalence of soft-tissue plasmacytomas, as observed in the ICARIA-MM and IKEMA studies (7.8% and 6.3%, respectively), the efficacy data from both studies were combined. PFS (HR, 0.47; 95 % CI, 0.21-1.08), overall response rate (50.0 % vs. 17.7 %), and excellent partial response or better rate (26.9 % vs. 11.8 %) were improved with Isa-Pd/Isa-Kd versus Pd/Kd, with consistent improvements within individual studies.
Patients with soft-tissue plasmacytomas who received Isa-Pd/Isa-Kd had similar median PFS compared with those without soft-tissue plasmacytomas and received Pd/Kd. Safety is reported individually per study. The ICARIA-MM and IKEMA studies revealed that Isa’s arm had a lengthier median treatment duration and a higher occurrence of Grade ≥ 3 treatment-emergent adverse events compared to the control arm (36.9 vs. 8.4 weeks; 85.7 % vs. 70.0 %) and (41.9 vs. 29.9 weeks; 100.0 % vs. 57.1 %), respectively. Nonetheless, the administration of Isa did not increase the proportion of patients who experienced fatal events or discontinued drug therapy. Isa-Pd or Isa-Kd is a potential new treatment option and partially overcomes the poor prognosis associated with soft-tissue plasmacytomas in relapsed and refractory multiple myeloma.
Source: https://pubmed.ncbi.nlm.nih.gov/36108425/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03275285/
Beksac M, Spicka I, Hajek R, Bringhen S, Jelínek T, Martin T, Mikala G, Moreau P, Symeonidis A, Rawlings AM, van de Velde H, Richardson PG. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022 Nov;122:106948. doi: 10.1016/j.leukres.2022.106948. Epub 2022 Sep 6. PMID: 36108425.
