| Autor: |
Chari A; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY., Suvannasankha A; Indiana University School of Medicine and Simon Cancer Center, Richard L. Roudebush VA Medical Center, Indianapolis, IN., Fay JW; Baylor Institute for Immunology Research, Dallas, TX., Arnulf B; Unité d'Immuno-hématologie, Assistance Publique-Hôpitaux de Paris, Centre d'Investigations Cliniques 1427, Hôpital Saint Louis Lariboisière, Paris, France., Kaufman JL; Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA., Ifthikharuddin JJ; James P. Wilmot Cancer Center, University of Rochester Strong Memorial Hospital, Rochester, NY., Weiss BM; Abramson Cancer Center and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Krishnan A; The Judy and Bernard Briskin Myeloma Center, City of Hope, Duarte, CA., Lentzsch S; Columbia University Medical Center, New York, NY., Comenzo R; Division of Hematology-Oncology, Tufts Medical Center, Boston, MA., Wang J; Janssen Research & Development, Raritan, NJ; and., Nottage K; Janssen Research & Development, Raritan, NJ; and., Chiu C; Janssen Research & Development, Spring House, PA., Khokhar NZ; Janssen Research & Development, Spring House, PA., Ahmadi T; Janssen Research & Development, Spring House, PA., Lonial S; Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA. |
| Abstrakt: |
Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N = 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pom-dex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients). Among patients with a complete response or better, 29% were MRD negative at a threshold of 10 -5 Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months and median overall survival was 17.5 (95% CI, 13.3-NE) months. The estimated 12-month survival rate was 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients. The study was registered at www.clinicaltrials.gov as #NCT01998971. |
