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news.Bristol-Myers Squibb Company and AbbVie announced that the US Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies.
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The approval of this first and only immunostimulatory antibody for multiple myeloma is based on data from the randomized, open-label, Phase 3, ELOQUENT-2 study, which demonstrated that the ERd regimen resulted in a 30% reduction in the risk of disease progression or death compared to Rd alone (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004]).
The co-primary endpoints were progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR). With a minimum of two years follow-up, ERd delivered a benefit in PFS that was maintained over time, with PFS rates of 68% versus 57% at one year and 41% versus 27% at two years in the ERd and Rd arms, respectively.
The ERd regimen also demonstrated a significant improvement in ORR, achieving an ORR of 78.5% (95% CI: 73.6% to 82.9%) versus 65.5% in the Rd arm (95% CI: 60.1% to 70.7%). The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).
Bristol-Myers Squibb chief scientific officer Francis Cuss said: "At Bristol-Myers Squibb, we are leading a revolution in cancer treatment that is changing expectations for patients with some of the hardest-to-treat cancers. With today’s approval of Empliciti, we are pleased to now bring the promise of our Immuno-Oncology research to patients with multiple myeloma.
"Empliciti represents a fundamentally different approach of directly activating the immune system in patients with relapsed or refractory multiple myeloma, delivering improved outcomes for those in need."
Empliciti is available for injection for intravenous use in 300 mg and 400 mg vials. The company expects to begin shipping Empliciti within the next 48 hours. Empliciti is also under review by the European Medicines Agency and has been granted accelerated assessment.
Discontinuation rates due to adverse reactions were similar across the ERd and Rd control arms (6.0% vs. 6.3%). ERd is associated with the following Warnings and Precautions: Infusion Reactions, Infections, Second Primary Malignancies, Hepatotoxicity, Interference with Determination of Complete Response, Pregnancy/Females and Males of Reproductive Potential, and Adverse Reactions. Please see the detailed Important Safety Information and a link to the Prescribing Information below.
"Multiple myeloma remains largely incurable, with only half of patients surviving five years after diagnosis," said Sagar Lonial, M.D., chief medical officer of the Winship Cancer Institute of Emory University.
"The approval of elotuzumab (Empliciti) provides renewed hope for the multiple myeloma community who urgently need a treatment option that extends the time patients live without their disease progressing."
AbbVie executive vice president of research and development and chief scientific officer Michael Severino said: "Empliciti in combination with lenalidomide and dexamethasone is an important new option for patients with multiple myeloma and healthcare providers who are treating this cancer.
"AbbVie is pleased to have partnered with Bristol-Myers Squibb in making this new treatment available for patients with relapsed or refractory multiple myeloma."