Myeloma: Therapy, excluding Transplantation: Novel Antibody Combinations in Myeloma
151 Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from Griffin, a Phase 2 Randomized Study of Daratumumab ﴾Dara﴿, Bortezomib ﴾V﴿, Lenalidomide ﴾R﴿, and Dexamethasone ﴾D; Dara‐Vrd﴿Vs. Vrd in Patients (Pts) with Newly Diagnosed (ND) Multiple Myeloma ﴾MM﴿Eligible for High‐Dose Therapy ﴾HDT﴿and Autologous Stem Cell Transplantation ﴾ASCT﴿
Peter M. Voorhees, et al.
The Abstract concludes: that the overall safety profile of dara-VRd was consistent with those previously reported for dara and VRd, with manageable toxicity and no new safety findings with longer therapy. Dara-VRd was active with an investigator-assessed VGPR+ rate of 100% and an sCR+CR rate of 63% after consolidation therapy. MRD negativity was seen in a subset of patients, and further analysis is underway and will be presented. SC mobilization proved successful in all pts. In aggregate, these data suggest that dara-VRd may be a very effective regimen in ASCT-eligible ND MM and that dara induction does not negatively impact SC mobilization. Enrollment to the 200-pt main phase of the randomized study is now complete, and primary endpoint (sCR after consolidation) will be available next year.
152 Lyra: A Phase 2 Study of Daratumumab (Dara) Plus Cyclophosphamide, Bortezomib, and Dexamethasone ﴾Cybord﴿in Newly Diagnosed and Relapsed Patients ﴾Pts﴿with Multiple Myeloma ﴾MM﴿
Habte A. Yimer, et al.
The Abstract concludes: Dara-CyBorD was active and well tolerated in pts with ND and RMM, including pts with high-risk cytogenetics. ORR, VGPR+, and CR rates improved with cycles 5-8 of induction, indicating that longer therapy with dara results in deeper response. Preliminary PFS and OS data in ND pts in the first year are comparable to dara-VMP. The safety profile was consistent with that previously reported for dara, with no new safety signals observed. Split first daratumumab dosing was feasible, reduced Day 1 infusion time, and resulted in a similar IR rate as previously described for single-dose administration. These findings indicate that dara-CyBorD, using a split-dose first infusion, can be safely administered in the community setting and may be an effective treatment option for pts with MM.
153 MOR202 with Low-Dose Dexamethasone (Dex) or Pomalidomide/Dex or Lenalidomide/Dex in Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase I/IIa, Multicenter, Dose-Escalation Study
Marc S Raab, et al.
The Abstract concludes: MOR202 administered as infusions as short as 30 minutes at doses up to 16 mg/kg with Dex or in combination with LEN/Dex or POM/Dex in heavily pretreated patients with RRMM showed a favorable safety profile, including good infusion tolerability. Promising efficacy and long-lasting tumor control were observed for MOR202 + Dex and in particular for MOR202 combined with LEN/Dex or POM/Dex.
154 Phase II Trial of Combination of Elotuzumab, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma
Chia-jen Liu, et al.
The Abstract concludes: The combination of elotuzumab, lenalidomide, and dexamethasone is well tolerated and demonstrates a high response rate with no progression to overt MM to date. Correlation with genomic studies can help define patients who benefit the most from this early therapeutic intervention.
155 Results from a Phase II Study of Isatuximab As a Single Agent and in Combination with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
Meletios A Dimopoulos, et al.
The Abstract concludes: A total of 165 patients received at least 1 cycle of treatment. Median age was 67 (37–85) years. Median time from diagnosis to first dose was 5.35 (0.7–23.0) years. Median number of prior lines was 4 (2–11) and median number of prior regimens was 6 (2–17). Patients received a median of 5 (1–17) cycles of treatment, with a median duration of exposure of 22 (1–69) weeks. Discontinuation occurred in 106 (64.2%) patients due to adverse events (15 patients, 9.1%), disease progression (85 patients, 51.5%), or patient decision (6 patients, 3.6%). The full efficacy and safety data for this heavily pre-treated RRMM population will be available for presentation at the meeting.
156 One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Predni-sone (D-VMP) Versus Bortezomib, Melphalan, and Predni-sone (VMP) in Patients (Pts) with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): Alcyone
Meletios A Dimopoulos, et al.
The Abstract concludes: With 1 year of additional follow-up, the combination of DARA and VMP in transplant ineligible NDMM pts continues to demonstrate a significant PFS benefit, including in pts ≥75 years of age, and allows for maintenance of PFS benefit during the subsequent line of therapy. Improvements in duration and depth of response continue to be observed with D-VMP with longer follow-up. No new safety signals emerged following the addition of DARA to VMP, and grade 3/4 infections continue to be manageable with no notable increase in rates. These results continue to support the use of D-VMP in the first line of treatment in transplant ineligible NDMM.