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.
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.
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.
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.