PF619 LENALIDOMIDE IN COMBINATION WITH DEXAMETHASONE AS FIRST‐LINE THERAPY IN TRANSPLANT‐INELIGIBLE PATIENTS WITH MULTIPLE MYELOMA: INTERIM RESULTS OF THE OBSERVATIONAL STUDY FIRST‐NIS

Abstract

Background:The lenalidomide‐dexamethasone (Rd) combination is a non‐alkylator‐based oral first‐line treatment option in transplant‐ineligible patients (pts) with multiple myeloma (MM). Approval of this regimen was based on the results of the pivotal phase III FIRST trial comparing Rd to the melphalan‐prednisone‐thalidomide (MPT) combination. Median OS was 10 months longer with Rd continuous versus MPT (Facon T et al., Blood 2018). Real‐world effectiveness and safety data of this commonly used first‐line treatment approach in the elderly population are still scarce.Aims:The focus of the first interim analysis is to evaluate baseline characteristics and early evidence for safety and effectiveness of first‐line Rd therapy documented in a real‐world patient population.Methods:The prospective, multicenter, non‐interventional, observational FIRST‐NIS study was designed to collect data on 167 pts with multiple myeloma receiving Rd as first‐line therapy from about 50 sites across Germany. Primary objective was to evaluate effectiveness of Rd assessed by 24‐month progression‐free survival (PFS) rate. Secondary endpoints included overall survival (OS), PFS, objective response rate (ORR), duration of response (DOR), quality of life (QoL) and safety. Descriptive statistics were used to analyze the data. The prespecified interim analysis was performed 24 months after the enrollment of the 50th patient.Results:At the cut‐off date of the interim analysis (July 3rd, 2018), 167 pts had been enrolled. Thereof, 155 pts qualified for effectiveness analysis and 159 pts for safety analysis. Baseline characteristics of all pts and of pts stratified by age (≤ 75 years, > 75 years) are presented (Table 1). The ORR was 53.5% in all pts, 60.9% in pts ≤ 75 years and 50.5% in pts > 75 years. 52.8% of pts developed grade 3/4 adverse events (AEs). Grade 3/4 AEs that occurred in at least 5% of pts were anemia (n = 9, 5.7%) and pneumonia (n = 8, 5.0%).Summary/Conclusion:The preliminary data of this interim analysis demonstrate a favorable risk‐benefit profile of Rd in the real‐world setting. Rd seems to be a reasonable first‐line treatment option that can also be provided to elderly pts > 75 years. The ORR results at this early analysis, however, are inferior compared to the outcomes of the pivotal phase III FIRST trial. One reason might be the high proportion of pts aged > 75 years in the FIRST‐NIS, i.e. 70% versus 35% in the FIRST trial. Results need to be confirmed in the final analysis.image