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Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.

Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.

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Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.
Indiana University School of Medicine and Simon Cancer Center, Richard L. Roudebush VA Medical Center, Indianapolis, IN.
Baylor Institute for Immunology Research, Dallas, TX.
Unité d'Immuno-hématologie, Assistance Publique-Hôpitaux de Paris, Centre d'Investigations Cliniques 1427, Hôpital Saint Louis Lariboisière, Paris, France.
Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
James P. Wilmot Cancer Center, University of Rochester Strong Memorial Hospital, Rochester, NY.
Abramson Cancer Center and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
The Judy and Bernard Briskin Myeloma Center, City of Hope, Duarte, CA.
Columbia University Medical Center, New York, NY.
Division of Hematology-Oncology, Tufts Medical Center, Boston, MA.
Janssen Research & Development, Raritan, NJ; and.
Janssen Research & Development, Spring House, PA.


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 as #NCT01998971.

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Blood. 2017 Sep 7;130(10):1189-1197. doi: 10.1182/blood-2017-03-775122. Epub 2017 May 1.

Pembrolizumab, pomalidomide, and low-dose dexamethasone for relapsed/refractory multiple myeloma.

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University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, MD.
Department of Pathology, University of Chicago, Chicago, IL; and.
Memorial Sloan Kettering Cancer Center, New York, NY.


Programmed death 1 (PD-1) receptor and its ligand (PD-L1) facilitate immune evasion in multiple myeloma (MM). We hypothesized that pembrolizumab, PD-1-antibody, can enhance antimyeloma cellular immunity generated by pomalidomide, leading to improved clinical responses. In this single-center, phase 2 study, 48 patients with relapsed/refractory MM (RRMM) received 28-day cycles of pembrolizumab, 200 mg IV every 2 weeks, pomalidomide 4 mg daily for 21 days, and dexamethasone 40 mg weekly. Patients had a median of 3 (range: 2-5) lines of therapy, median age 64 (range: 35-83) years, and had received both an immune modulatory drug (IMiD) and proteasome inhibitor: (35 [73%] of 48) were refractory to both; (31 [70%]) had received an autologous transplant, and (30 [62%]) had high-risk cytogenetics. Adverse events grade 3 to 4 occurred in (19 [40%] of 48 patients), including hematologic toxicities (19 [40%]), hyperglycemia (12 [25%]), and pneumonia (7 [15%]). Autoimmune events included pneumonitis (6 [13%]) and hypothyroidism (5 [10%]), mostly ≤ grade 2. Objective responses occurred in (29 [60%] of 48) patients, including stringent complete response/complete response (4 [8%]), very good partial response (9 [19%]), and partial response (16 [33%]); median duration of response was 14.7 months. At median follow-up of 15.6 months, progression-free survival (PFS) was 17.4 months and overall survival was not reached. Analyses of pretreatment marrow samples revealed a trend for increased expression of PD-L1 in responding patients and longer PFS with increased T-lymphocyte infiltrates, irrespective of PD-1 expression. Pembrolizumab, pomalidomide, and low-dose dexamethasone have acceptable safety and durable responses in RRMM patients. This trial was registered at as #NCT02289222.

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