dm+d

32817811000001108

Refrigerated Storage

Empliciti▼Bristol-Myers Squibb Pharmaceutical Limited

Bristol-Myers Squibb Pharmaceutical Limited
Empliciti▼
Powder for concentrate for solution for infusion

Contact Bristol-Myers Squibb in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

21 May 2019
London MI Service

New Medicines

EmplicitiMultiple myeloma (MM), relapsed or refractory - third-line in combination with pomalidomide and low-dose dexamethasone

Information

Empliciti
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Launched
Launched
Launched
August 2019
Yes
Yes
Aug 19Approved in the EU [9].
Jul 19Recommended 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).” [8].
Nov 18Approved in US [5].
Sep 18Filed 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 [7].
Aug 18US 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 [4].
Jan 18Has orphan drug status in EU & US [2].

Category

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
Intravenous

Further information

Yes
Suspended

Trial or other data

Nov 18Results of PII NCT02654132 published in NEJM [6].
Jun 18Bristol-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 [3].
Dec 17Recruitment has completed in PII ELOQENT-3 study (NCT02654132) [1].
Mar 16PII 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 [1].

Evidence based evaluations

EmplicitiMultiple myeloma (MM), first-line in combination with lenalidomide

Information

Empliciti
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Yes
Yes
Mar 20Eloquent-1 study did not meet its PFS primary endpoint. Regulatory filing will not be pursued in the EU. No longer listed in AbbVie pipeline; assume all development stopped [11,12].

Category

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), first-line in combination with lenalidomide
Intravenous

Further information

Yes
To be confirmed

Trial or other data

Mar 20Topline 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. [10]

Evidence based evaluations