ASH Clinical News Hematology Pipeline Update: Drug Updates from the | Page 12

For the treatment of ultiple yeloma in combination with Rd
relative to Rd alone, EMPLICITI delivered

A BENEFIT IN PFS THAT WAS

AINTAINED
OVER TI E
1,2

in patients who had received 1 to 3 prior therapies

Co-primary endpoints: PFS HR 0.70 [95% CI, 0.57, 0.85]; P=0.0004*;
ORR† 78.5% with ERd [95% CI, 73.6, 82.9] vs 65.5% with Rd [95% CI, 60.1, 70.7]; P=0.00021‡
IMPORTANT SAFETY INFORMATION (continued)

Infections
• In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with
lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28%
(ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and
5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal
infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
• In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7%
(Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported
in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.
Hepatotoxicity
• Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and
alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients
experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor
liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values,
continuation of treatment may be considered.
Interference with Determination of Complete Response
• EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and
immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination
of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential