P-308: Superiority of daratumumab plus lenalidomide and dexamethasone in first and second relapse in multiple myeloma patients: a real-world single centre retrospective analysis

Introduction: The anti-CD38 antibody daratumumab is an important part of the treatment strategy in newly diagnosed and relapsed/refractory multiple myeloma (MM) patients. Data proving the benefit of daratumumab-based over non-daratumumab based regimens in the real-world setting are still limited. The aim of this real-world data analysis was to evaluate the clinical benefit of the use of daratumumab in 2nd and 3rd line treatment in a large cohort of anti-CD38 naïve patients with relapsed MM treated in the University Hospital Leuven, Belgium.

Methods: Data from the UZ Leuven patient database were analysed through the Augmenting THerapeutic Effectiveness through Novel Analytics (ATHENA) platform. The UZ Leuven Multiple Myeloma database was transformed to the OMOP-Common Data Model 5.3.1 as part of the ATHENA project. Patient data were collected until April 12, 2022. Different cohorts were identified based on daratumumab or non-daratumumab treatment in 2nd line treatment (DARA-2 versus non-DARA-2) and 3rd line treatment (DARA-3 versus non-DARA-3). We analysed the time to next treatment and overall survival from 2nd line treatment (TTNT2; OS2) and from 3rd line treatment (TTNT3; OS3).

Results: A total of 217 patients were included in this retrospective analysis. The cohorts contained respectively 107 patients in DARA-2, 39 patients in non-DARA-2, 39 patients in DARA-3 and 74 patients in non-DARA-3. In the DARA-2 cohort, 73 patients were treated with daratumumab-lenalidomide-dexamethasone (DRd) and 34 patients with daratumumab-bortezomib-dexamethasone (DVd). The median TTNT2 was 11,0 months in the DVd group versus not been reached (NR) in the DRd group (HR: 3,75; 95% CI: 2,1-6,68; p < 0,001). In the DVd group, median OS2 was 21, 8 months versus not been reached in the DRd group (HR: 2,99; 95%CI: 1,38-6,48; p=0,005). The median TTNT2 was significantly longer in the DRd group compared to the non-DARA-2 cohort (NR vs 20,5 months; HR: 0,44; 95% CI: 0,25-0,76; p=0,003). In the DARA-3 cohort, 29 patients were treated with DRd and 10 patients with DVd. The median TTNT3 was longer for the DRd group compared to the DVd group (20,7 vs 5,4 months; HR: 4,41; 95% CI 1,94-9,98; p< 0,001). The longest OS3 was also observed in the DRd group (41,9 months), compared to the DVd group (18,9 months) (HR: 2,82; 95% CI: 1,08-7,32; p=0,03). The median TTNT3 was significantly longer in the DRd group compared to the non-DARA-3 cohort (20,7 vs 5,8 months; HR: 0,49; 95% CI: 0,29-0,82; p=0,006).

Conclusions: This single centre real-world data analysis shows the clinical benefit of dara-based over non-dara based regimens in first and second relapse. In addition, compared with DVd, DRd is associated with significantly longer TTNT and survival.