Empliciti · Multiple myeloma (MM), relapsed or refractory - third-line in combination with pomalidomide and low-dose dexamethasone
Licence extension / variation
Development and Regulatory status
Aug 19 · Approved in the EU .
Jul 19 · Recommended for EU approval by CHMP - the additional indication is "in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).” .
Nov 18 · Approved in US .
Sep 18 · Filed in EU for use in combination with pomalidomide and low-dose dexamethasone in adult patients with MM who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy .
Aug 18 · US FDA accepts for priority review licence extension application for elotuzumab plus pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed or refractory multiple myeloma. Application is based on PII ELOQUENT-3 trial. Application action date is 27/12/18 .
Jan 18 · Has orphan drug status in EU & US .
Humanized anti-CS1 monoclonal IgG1 antibody
The incidence of MM in the UK is about 5 per 100,000 population. Median survival of patients with stage II and III disease is 45 and 29 months, respectively.
Multiple myeloma (MM), relapsed or refractory - third-line in combination with pomalidomide and low-dose dexamethasone
Nov 18 · Results of PII NCT02654132 published in NEJM .
Jun 18 · Bristol-Myers Squibb announced that the PII ELOQUENT-3 trial (n=117) achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS for patients treated with elotuzumab plus pomalidomide and dexamethasone (EPd) compared with pomalidomide and dexamethasone (Pd) alone. EPd patients experienced a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) vs Pd alone, with median PFS of 10.3 months (95% CI: 5.6 to not estimable) vs 4.7 months (95% CI: 2.8 to 7.2). The PFS benefit experienced among EPd patients was consistent among patients who had received two to three prior lines of therapy (HR 0.55; 95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51; CI 95%: 0.24 to 1.08). The safety profile for EPd was consistent with prior findings for elotuzumab and pomalidomide regimens .
Dec 17 · Recruitment has completed in PII ELOQENT-3 study (NCT02654132) .
Mar 16 · PII ELOQUENT-3 trial to evaluate the effect of addition of elotuzumab to pomalidomide and low-dose dexamethasone combination therapy in patients with relapsed and refractory MM starts (NCT02654132). It will enrol 121 patients in the US, Australia, Japan, Canada, France, Germany, Greece, Spain, Poland, the Netherlands and Italy. Primary outcome is PFS and collection should complete Jan 18 .
Mar 20 · Topline data from the PIII ELOQUENT-1 study (NCT01335399) show that the addition of Empliciti to lenalidomide in transplant-ineligible pts with MM failed to acheive a statistically significant improvement in PFS vs. std of care. Overall survival data are yet to be announced and no new safety signals were observed in the trial.