FDA Approves Immunotherapy Combination for Certain Patients with Multiple Myeloma

Elotuzumab (Empliciti) with pomalidomide and dexamethasone (Pd) is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator.

Officials with the FDA have approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of certain patients with relapsed or refractory multiple myeloma, according to a press release.¹

EPd is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator, according to Bristol-Myers Squibb.¹

The approval is based on data from the ELOQUENT-3 phase 2 trial which evaluated elotuzumab plus pomalidomide and dexamethasone (Pd) versus Pd in 117 patients with relapsed or refractory multiple myeloma who received 2 or more prior therapies, including lenalidomide and a proteasome inhibitor. According to the results, EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) versus Pd.¹

The approved dose of EPd is 10 mg/kg administered intravenously every week for the first two 28-day cycles, followed by 20 mg/kg every 4 weeks until disease progression or unacceptable toxicity.¹

According to the release, key data from the trial include¹:

EPd reduced the risk of disease progression by 46% (hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.34 to 0.86, p=0.0078), demonstrating a median PFS of 10.25 months (95% CI: 5.59 to non-estimable [NE]) versus 4.67 months (95% CI: 2.83 to 7.16) for Pd alone after a minimum follow-up of 9.1 months.
Response rates doubled in patients receiving EPd n=32/60 [95% CI: 40.0 to 66.3]) compared with patients receiving Pd alone (26.3%; n=15/57 [95% CI: 15.5 to 39.7]; p=0.0029), with very good partial responses or better seen in 20% of EPd-treated patients (n=12) and 8.8% of Pd-treated patients (n=5).
Serious adverse reactions were reported in 22% of patients treated with EPd and in 15% of patients treated with Pd. Discontinuation of any component of the treatment regimen due to adverse reactions occurred in 5% of patients in the EPd arm, compared with 1.8% of patients in the control 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,” Paul Richardson, MD, clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement.¹ “Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients.”

Elotuzumab is also indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received 1 to 3 prior therapies.²

References

US Food and Drug Administration Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma [news release]. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/bristolmyers/us-food-and-drug-administration-approves-empliciti-elotuzumab-plus-pomali. Accessed November 6, 2018.
Empliciti Prescribing Information. Empliciti U.S. Product Information. Last Updated: November 2018. Princeton, NJ: Bristol-Myers Squibb Company.