BMS Receives EU Approval for Second Empliciti-Based Triplet Regimen (EPd) for Relapsed/Refractory Multiple Myeloma
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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Bristol-Myers Squibb (BMS) announced on August 27 that its immunomodulatory drugEmpliciti (elotuzumab) in Combination with Pomalidomide and Low-Dose Dexamethasone (EPd) Regimen Approved by the European Union, for use in patients who have previously received at least two therapies and whose disease has been demonstrated to progress during the most recent therapyRelapsed and Refractory Multiple Myeloma (MM)Adult patients.
This approval is based on data from the ELOQUENT-3 study: compared with the pomalidomide plus low-dose dexamethasone regimen (Pd), the EPd regimen doubled progression-free survival (PFS) and overall response rate (ORR).
EPd is the second Empliciti-based combination regimen approved in the EU; the first, ELd (Empliciti + lenalidomide + low-dose dexamethasone), was approved in 2016 for patients with multiple myeloma (MM) who had previously received 1–3 prior therapies. In the United States, the ELd and EPd regimens were approved by the FDA in 2015 and 2018, respectively.
EPd is also the first three-drug combination therapy approved by the European Union based on a randomized clinical trial using the standard-of-care Pd regimen as the positive control. Data from the randomized, open-label Phase II ELOQUENT-3 study demonstrated that the EPd regimen significantly improved progression-free survival (PFS) and overall response rate (ORR) compared with the Pd regimen in patients with relapsed/refractory multiple myeloma (MM). The median PFS was 10.25 months for EPd versus 4.67 months for Pd, representing a 46% reduction in the risk of disease progression with EPd. The ORR in the EPd group was 53.3%, significantly higher than the 26.3% observed in the Pd group.
Latest efficacy results presented at the 24th Annual Congress of the European Hematology Association showed that, with a minimum follow-up of 18.3 months, 40 patients (67%) in the EPd treatment group remained alive, compared with 29 patients (51%) in the Pd treatment group. The median overall survival for the EPd treatment group has not yet been reached.
In terms of safety, treatment-related grade 3–4 adverse events were comparable between the EPd and Pd treatment groups. The incidence of infections of any grade was 65% in both treatment groups. Despite longer drug exposure in the EPd group and similar pomalidomide dose intensity in both groups, the incidence of the most common grade 3–4 hematologic adverse events was lower in the EPd group than in the Pd group (neutropenia: 13% vs. 27%; anemia: 10% vs. 20%). Discontinuation due to adverse events occurred in 18% of patients in the EPd group and 24% of patients in the Pd group.
▲Mechanism of Action of Empliciti Immunotherapy Combination
Empliciti is an innovative immune-stimulatory antibody co-developed by Bristol-Myers Squibb and AbbVie, which specifically targets the SLAMF7 glycoprotein on the cell surface. This glycoprotein is expressed on the surface of myeloma cells as well as on natural killer (NK) cells.
Empliciti has two mechanisms of action. On one hand, it can directly activate NK cells through the SLAMF7 signaling pathway, thereby enhancing the immune response. On the other hand, it can bind to the SLAMF7 protein on the surface of myeloma cells, tagging these tumor cells so that NK cells can kill them through antibody-dependent cellular cytotoxicity.
According to the performance report released by Bristol-Myers Squibb, the drug’s sales amounted to USD 247 million in 2018 and USD 174 million in the first half of this year.
References:
1、European Commission Approves Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
2. BMS’s Innovative Immunotherapy Combination for Multiple Myeloma Expands Indications
3、Bristol-Myers Squibb Reports Second Quarter Financial Results
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.