Primary analysis of the randomized phase II trial of bortezomib, lenalidomide, dexamthasone with/without elotuzumab for newly diagnosed, highrisk multiple myeloma (SWOG-1211).

 

Abstract No : 8507

Abstract Type : Oral Abstract Session

Indication : Multiple Myeloma

Intervention : Elotuzumab

Company : BMS

Technology : Monoclonal antibody

 

Results:

S1211 enrolled 103 evaluable patients, RVd n = 54, RVd-Elo n = 49. 75% had ISS II/III, 47% amp1q21, 38% del17p, 12% t(14; 16), 9% GEPhi, 7% pPCL, 5% t(14; 20) and 4% elevated serum LDH (18.5% > 1 feature). With median follow-up of 53 months (mos.), no difference in median PFS was observed [RVd-Elo = 31 mos., RVd = 34 mos.,HR = 0.968 (80% CI = 0.697-1.344), p = 0.449]. No difference in OS was observed [RVd-Elo = 68 mos, RVd = not reached, HR = 1.279 (80% CI: 0.819, 2.000), p-value = 0.478]. 72% pts had > Grade 3 AEs, no differences in the safety profile were observed except >Grade 3 infections (RVd 8%, RVd-Elo 16%), >Grade 3 sensory neuropathy (RVd 8%, RVd-Elo 13%).

 

Conclusion:

In the first randomized HRMM study reported to date, the addition of elotuzumab to RVd induction and maintenance did not improve patient outcomes. However, the PFS and OS seen in both arms of the study exceeded the original statistical assumptions and support the role for PI/IMiD combination maintenance therapy for this patient population. The S1211 data will serve as an important benchmark for future HRMM clinical trials.

 

Commentary:

BMS and AbbVie’s hopes of moving its multiple myeloma therapy Empliciti up the treatment pathway into first-line use have hit a major snag.

Note: The therapeutics segment is experiencing significant Multiple Myeloma clinical trial activity, which is further expected to drive Multiple Myeloma market growth in the coming years.