REAL-WORLD USE OF THE TRIPLET REGIMEN CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (KRD) IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA: A SUB-GROUP INTERIM ANALYSIS FROM A PROSPECTIVE OBSERVATIONAL STUDY
Author(s): ,
Xavier Leleu
Affiliations:
Department of Hematology,CHU la Miletrie and Inserm CIC 1402,Poitiers,France
,
Barbara Gamberi
Affiliations:
Azienda USL-IRCCS di Reggio Emilia,Reggio Emilia,Italy
,
Jo Caers
Affiliations:
Department of Hematology,CHU de Liège,Liège,Belgium
,
Sonja Heibl
Affiliations:
Klinikum Wels-Grieskirchen GmbH,Wels,Austria
,
Maaike Söhne
Affiliations:
St Antonius Hospital,Nieuwegein,Netherlands
,
Florence Suzan
Affiliations:
Amgen (Europe) GmbH,Rotkreuz,Switzerland
,
Zsolt Szabo
Affiliations:
Amgen (Europe) GmbH,Rotkreuz,Switzerland
,
Abeera Mohammad
Affiliations:
Global Biostatistical Science,Amgen Ltd,Uxbridge,United Kingdom
,
Sally Wetten
Affiliations:
Centre for Observational Research,Amgen Ltd,Uxbridge,United Kingdom
Evangelos Terpos
Affiliations:
Department of Clinical Therapeutics,School of Medicine, National and Kapodistrian University of Athens,Athens,Greece
EHA Library. Leleu X. Jun 14, 2019; 266415; PF616
Dr. Xavier Leleu
Dr. Xavier Leleu
Contributions
Abstract

Abstract: PF616

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
Previous interim results from a large observational study (NCT03091127) describing the usage of carfilzomib (CFZ)-based regimens in patients (pts) with relapsed multiple myeloma (MM) showed that pts who received KRd, are younger and receive CFZ in earlier lines than pts treated with CFZ and dexamethasone alone.

Aims
To further characterize the KRd pt population, describe CFZ use and benefit-risk profile in this real-world setting.

Methods
The study recruited adult pts who received ≥1 prior line of therapy and ≥1 CFZ dose in routine care. Data collected were as described in HemaSphere 2018;2(S1):962 (PB2153).

Results
In a planned interim analysis, of 293 pts enrolled from 14 Mar 2017 and 22 Oct 2018 across 10 participating countries in EU and Israel, 178 (60.7%) pts received KRd. Median follow-up time of KRd pts was 8.5 months (mos). At KRd initiation, median age was 64 years and 9.6% were ≥75 years. Nearly all (97.8%) pts had an ECOG status 0-2 (Table 1). Hypertension (HT, 28.7%), diabetes (12.4%), cardiac disorder (10.1%), and renal disorder (4.5%) were reported in medical history. KRd pts had a median (range) of 1 prior line of therapy (1, 8). Median time since last prior treatment discontinuation was 16.9, 4.6, and 1.1 mos for pts with 1, 2, or ≥3 prior lines, respectively. Over half (63%) of KRd pts had a previous hematopoietic stem cell transplant (HSCT). Among patients at 1st relapse, nearly all (90%) received frontline bortezomib and 44% an IMiD of which 74% were exposed to thalidomide and 37% to lenalidomide (LEN). Among 142 evaluable pts, complete response or better (CR+), or very good partial response or better (VGPR+) was achieved by 22% and 61% of pts, respectively. The best overall response rate (ORR) was obtained within a median time of 3.6 mos and was high irrespective of the number of prior lines of therapy (Table 2). More patients achieved CR+ in earlier lines (Table 2). Nearly all (97%) pts had a planned KRd dosing schedule per EU label (twice weekly CFZ 20/27 mg/m2) and pts received on average 95% of the total expected dose. Out of 175 pts starting a twice-weekly schedule, 9.0% switched to once-weekly. Among 98 pts assessed for frailty at diagnosis, 32% were intermediate (int) or frail. Median age was similar between frail/int and fit pts (65 vs 64 at KRd initiation). The average % expected dose received by both frail/int and fit pts was high: 97% vs 96%, respectively. For all pts receiving KRd, the Kaplan-Meier median estimate of treatment duration was 16.6 mos (95% confidence interval: 11.1, 19.8). Among 74 pts discontinuing CFZ, the main reasons were disease progression/refractoriness (25.7%), desired level of response reached (20.3%), or an adverse event (AE, 17.6%). Salvage HSCT was planned for 29.7% of pts discontinuing CFZ and LEN. One-third (34.3%) of KRd pts reported AEs of grade 3 and above (Gr3+), including HT (3.4%) and cardiac failure (0.6%) and 5 fatal events occurred. Blood cell disorders (12.4%) such as anemia and neutropenia, and infections (11.2%) were the most frequent type of events reported.

Conclusion
Patients receiving KRd in real-world were consistent with those in the KRd arm of the pivotal ASPIRE trial in terms of age and prior lines of therapy. Additionally, KRd is shown to be used in practice in frail patients. Importantly, in this analysis, CFZ was appropriately prescribed per EU label and could be maintained for long durations leading to high ORRs and deep responses.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Clinical outcome, Epidemiology, Multiple myeloma, Relapse

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