Currently Viewing:
Newsroom
Currently Reading
FDA Approves New Immunotherapy Combination for Relapsed/Refractory Multiple Myeloma
November 07, 2018 – Samantha DiGrande
Pembrolizumab Plus Chemotherapy Approved to Treat Metastatic Squamous NSCLC
November 01, 2018 – Samantha DiGrande
CAR T Cells Improve Antitumor Activity in Hepatocellular Carcinoma
November 01, 2018 – David Bai, PharmD
PD-1 Inhibitors Effective in Metastatic Conjunctival Melanoma
October 26, 2018 – David Bai, PharmD
Atezolizumab Plus Chemotherapy Prolongs PFS in Triple-Negative Breast Cancer
October 23, 2018 – Samantha DiGrande
Switchable CAR T Cells May Be Safer in Pancreatic Cancer
October 19, 2018 – David Bai, PharmD
Opdivo Fails to Meet Primary Endpoint in Phase 3 SCLC Trial
October 17, 2018 – Samantha DiGrande
Three Genetic Types Drive Higher Prevalence of MM in African Americans
October 14, 2018 – Laura Joszt
FDA Approves Libtayo to Treat Second Most Common Skin Cancer
October 09, 2018 – Samantha DiGrande

FDA Approves New Immunotherapy Combination for Relapsed/Refractory Multiple Myeloma

Samantha DiGrande
Today, the FDA approved elotuzumab (Empliciti), an injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies.
Today, the FDA approved elotuzumab (Empliciti), an injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies.

The approval was based on data from the ELOQUENT-3 trial, a randomized, open-label, phase 2 study that enrolled 117 patients and found that EPd demonstrated a benefit in patients with relapsed or refractory multiple myeloma. Patients were randomized in a 1:1 ratio to receive either EPd (n = 60) or pomalidomide and dexamethasone (n =57) in 28-day cycles until disease progression or unacceptable toxicity. The study found that the combination treatment doubled both the median progression-free survival and overall response rate versus pomalidomide and dexamethasone alone.

“Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving healthcare professionals an effective new tool to tackle this relentless cancer,” said Joseph Eid, MD, senior vice president and head of medical, Bristol-Myers Squibb.

The trial specifically demonstrated that the combination treatment reduced the risk of disease progression by 46% (hazard ratio: 0.54; 95% CI: 0.34 to 0.86, P = 0.0078). This finding in turn led to a median progression-free survival of 10.25 months compared with 4.67 months for pomalidomide and dexamethasone alone.

Researchers found that serious adverse events were reported in 22% of the patients treated with EPd, and in 15% of patients treated with pomalidomide and dexamethasone. Treatment discontinuation due to adverse events occurred in 5% of patients enrolled in the EPd arm, compared with 1.8% in the pomalidomide and dexamethasone arm.

“This new regimen of elotuzumab combined with pomalidomide and dexamethasone not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them,” said Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.

Following priority review by the FDA, EPd is the first triplet combination to be approved on a randomized clinical trial using pomalidomide and dexamethasone as a comparator.

Related Articles

ELOQUENT-3 Meets Its Primary End Point in Treating Relapsed/Refractory Multiple Myeloma
Addressing Unmet Needs in Multiple Myeloma
Early Access to Daratumumab Confirms Safety in Relapsed/Refractory Multiple Myeloma
 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up