Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b–2 dose-escalation study

Abstract

Bristol-Myers Squibb, AbbVie Biotherapeutics.

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma

“…Thirty-one patients had the infusion rate escalated to 5 mL/min; 33% of all infusions given during the study were at 5 mL/min, and one patient experienced an IR (Grade 1 nausea) at this rate. 19 In study 009 of elotuzumab plus bortezomib/dexamethasone, the rate of IRs was 5%; all were Grade 1/2. One IR was reported among the 27 patients who had received the 5 mL/min infusion.…”

“…If an infusion reaction (IR) did not occur, the infusion rate could be increased to 5 mL/min (duration 1 h) after Cycle 4. 19,20 In study 1703, patients with RRMM receiving elotuzumab plus lenalidomide and dexamethasone demonstrated an overall response rate (ORR) of 84% and a median progression-free survival of 28.6 months. 19 The most common Grade 3/4 adverse events (AEs) were lymphopenia (21%) and neutropenia (19%).…”

“…19,20 In study 1703, patients with RRMM receiving elotuzumab plus lenalidomide and dexamethasone demonstrated an overall response rate (ORR) of 84% and a median progression-free survival of 28.6 months. 19 The most common Grade 3/4 adverse events (AEs) were lymphopenia (21%) and neutropenia (19%). As a result of previous trials, elotuzumab was studied in combination with lenalidomide in the phase 3 ELOQUENT-2 study, in which patients receiving elotuzumab plus lenalidomide and dexamethasone showed a 30% relative reduction in the risk of disease progression or death when compared with patients receiving lenalidomide and dexamethasone alone, with minimal incremental toxicity.…”

“…20 The premedication regimen and administration schedule of these medications implemented in studies 1703 and 009 were shown to successfully reduce the number and severity of IRs associated with elotuzumab. 19,22 As a result, this premedication regimen, or an appropriate equivalent, is currently required for all patients prior to infusion of elotuzumab. In the ELOQUENT-2 study, patients received the premedication regimen that had been developed during study 1703.…”

Immunotherapy: the next step in the treatment of myeloma

“…4 In the Lancet Haematology, the authors present final results from a phase 1b/2 randomized study of elotuzumab -10 mg/kg or 20 mg/kg -in combination with lenalidomide and dexamethasone in relapsed myeloma patients who received one to three prior lines of therapy. 6 Twenty-nine patients were enrolled in the phase 1 and 73 in the phase 2. In the latter, 36 patients were randomized to receive elotuzumab at 10 mg/kg and 37 patients to elotuzumab at 20 mg/kg.…”