Prommis Trial Prospectively Demonstrates the Efficacy of SKY92 Risk Stratification in Newly Diagnosed Multiple Myeloma Patients

• Published in: Blood 2023-11, Vol.142 (Supplement 1), p.3386-3386
• Main Authors: Biran, Noa, Dhakal, Binod, Niesvizky, Ruben, Lentzsch, Suzanne, McKay, John T., Vesole, David H., Nooka, Ajay K., Paul, Barry, Hari, Parameswaran N., Stork-Sloots, Lisette, D'Ambrosi, Silvia, Kuiper, Rowan, van Vliet, Martin, Siegel, David S., Usmani, Saad Z, van Rhee, Frits
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2023-180761

Introduction: Multiple myeloma (MM) is a complex hematologic malignancy characterized by genetic instability, variable survival rates, and diverse treatment responses. SKY92 gene expression profiling (GEP) is a valuable tool in risk stratifying patients into high-risk and standard-risk groups for progression and survival. The PRospective Observational Multiple Myeloma Impact Study (PROMMIS; NCT02911571) trial, a prospective US multicenter study, was designed to validate the prognostic performance of SKY92 through real-world data. Methods: The GEP of 251 newly diagnosed MM patients was assessed using the SKY92 assay (SkylineDx, San Diego), which involved analyzing RNA extracted from CD138-positive plasma cells (≥80% purity) isolated through immunomagnetic separation. The test was performed at the enrolling institute, or by sending the samples into a central lab. The standard method for risk stratification by R-ISS stage was integrated with SKY92 into three distinct groups: Low-Risk (LR), defined by SKY92 standard-risk (SR) combined with R-ISS I; Intermediate Risk (IR), as SKY92 SR with R-ISS II/III, or SKY92 high-risk with R-ISS I; and High-Risk as SKY92 high-risk with R-ISS II/III. Progression-free survival (PFS) and overall survival (OS) were available for 221 patients, measured from the date of diagnosis of the patients. The median follow-up at the time of analysis is 38 months. Survival analyses were performed using Cox proportional hazards model. Results: Upon analysis, 179 patients (71.3%) were classified as SKY92 standard-risk, and 72 patients (28.7%) as SKY92 high-risk. Notably, the percentage of high-risk patients in this study was slightly higher than that observed in previous retrospective analyses (15-25%). Furthermore, the survival analysis revealed significant differences in both PFS (HR: 2.1, 95%CI 1.4-3.1, p