ASH Clinical News ACN_4.3_FULL-ISSUE-DIGITAL | Page 27

CLINICAL NEWS Brentuximab Vedotin Plus Nivolumab May Be an Alternative to Salvage Chemotherapy in Relapsed/Refractory Hodgkin Lymphoma • 5 (8.3%) experienced progressive disease • 5 (8.3%) did not respond Seventeen patients received subsequent salvage therapy, most of whom received ICE (ifosfamide, carboplatin, etoposide; n=12). Response rates were similar in this subset: overall response rate was 80 percent (95% CI 52-96), with a 40 percent CR rate (95% CI 16-68). At analysis, 54 patients had undergone AHCT: 41 (76%) had CR, 11 (20%) had PR, and one (2%) had stable disease (1 patient was not evaluable). Most (n=42) were able to proceed directly to AHCT after treatment with brentuximab vedotin and nivolumab, suggesting that “[this combination] is an T:7” S:6.75” EXPLORE THE COVERAGE OF KOVALTRY ® Dosing with KOVALTRY ® for routine prophylaxis in adults 1 : Individualize the patient’s dose based on clinical response Dose Regimen 20–40 IU/kg 2x/week or 3x/week LEOPOLD I trial: KOVALTRY ® PK results (arithmetic mean) 1 PK parameters were measured using chromogenic substrate assay after a single 50-IU/kg dose of KOVALTRY ® in 21 previously treated patients ≥18 years old The AUC was 2103.4 IU•h/dL The C max was 133.1 IU/dL The t 1/2 was 14.2 hours AUC=area under the curve. C max =maximum concentration. LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease. PK=pharmacokinetics. t 1/2 =half-life. See how KOVALTRY ® compared with Advate ® in a cross-over PK study INDICATIONS KOVALTRY ® Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes KOVALTRY ® is not indicated for the treatment of von Willebrand disease. SELECTED IMPORTANT SAFETY INFORMATION KOVALTRY ® is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY ® . Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY ® if symptoms occur and seek immediate emergency treatment. Please see additional Selected Important Safety Information on the following pages. For additional risk and use information, please see Brief Summary on following pages. ASHClinicalNews.org • 37 (61.7%) experienced a complete response (CR; primary endpoint) • 13 (21.7%) experienced a partial response (PR) In a phase I/II study published in Blood, the combination of brentuximab vedotin plus nivolumab was an effective first salvage therapy in patients with relapsed/refractory Hodgkin lymphoma (HL), with 83 percent of patients responding to treatment. The response rates reported in this study “are higher than those observed with brentuximab vedotin or nivolumab alone in relapsed/refractory HL and are higher than with brentuximab vedotin … as initial salvage therapy,” noted lead author Alex F. Herrera, MD, from the Department of Hematology/Hemato- poietic Cell Transplantation at the City of Hope Medical Center in Los Angeles, California, and co-authors. The findings suggest this combination could provide an alternative to traditional chemotherapy. The open-label, multicenter study included adults who were eligible for autologous hematopoietic cell trans- plantations (AHCT), had disease that relapsed or was refractory to standard frontline chemotherapy, and had an Eastern Cooperati