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1 and ixazomib, panobinostat, elotuzumab, and daratumumab).
2 es showed a specific tumoral accumulation of Daratumumab.
3 treated with 185 kBq or 277.5 kBq of (212)Pb-Daratumumab.
4 eactivity, and specificity of [(89)Zr]Zr-DFO-daratumumab.
5 achieved with a 200-fold excess of unlabeled daratumumab.
6 to target one another after the addition of daratumumab.
7 CD38, the target of the therapeutic antibody daratumumab.
8 matological cancers, including rituximab and daratumumab.
9 counted life-years compared with second-line daratumumab.
10 ontrol in 2 therapeutic mouse models, unlike daratumumab.
11 MM (r/r MM) displaying lower sensitivity to daratumumab.
12 d to evaluate CD38-specificity of (89)Zr-DFO-daratumumab.
13 treated with 185 kBq or 277.5 kBq of (212)Pb-daratumumab.
14 ved 74 MBq (2 mCi) of intravenous (89)Zr-DFO-daratumumab.
15 es showed a specific tumoral accumulation of daratumumab.
16 y of subcutaneous daratumumab to intravenous daratumumab.
17 ent dosing was per the approved schedule for daratumumab.
18 analysis included 148 patients who received daratumumab 16 mg/kg (42 patients in GEN501 part 2; 106
23 2 of GEN501, patients were given intravenous daratumumab 16 mg/kg once per week for 8 weeks, twice pe
24 t 2 of SIRIUS, patients received intravenous daratumumab 16 mg/kg once per week for 8 weeks, twice pe
27 alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratum
28 r 28-day cycles of Dara-KRd, each comprising daratumumab (16 mg/kg intravenously on days 1, 8, 15, an
29 in the D-VMP group also received intravenous daratumumab (16 mg/kg of bodyweight, once weekly during
30 n day 1 of each 21-day cycle) or intravenous daratumumab (16 mg/kg once a week in cycles 1-3, every 3
31 4), and 20 mg after cycle 4; and intravenous daratumumab, 16 mg/kg (days 1, 8, 15, and 22 [cycles 1-2
33 ocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 stage 1 of the
35 e report the use of CD38 monoclonal antibody daratumumab (9-mo course) in a kidney allograft recipien
36 previously treated AL patients who received daratumumab, a CD38-directed monoclonal antibody approve
46 mbination of TAK-981 with anti-CD38 antibody daratumumab also resulted in enhanced antitumor activity
48 e, 30 patients received 8 mg per kilogram of daratumumab and 42 received 16 mg per kilogram, administ
49 therapy, of whom 24.7% versus 33.9% received daratumumab and 71.8% versus 76.9% received PIs (next-li
50 8 on tumor cells on a different epitope than daratumumab and a detuned scFv domain affinity binding t
52 ab'(OBN)-MORF1), whereas Fab' fragments from Daratumumab and Isatuximab (Fab'(DARA)-MORF1 and Fab'(IS
53 antitumor efficacy and better survival than daratumumab and isatuximab against EL4 thymoma or VK*MYC
54 ave shown enhanced therapeutic efficacy when daratumumab and isatuximab are combined with other agent
57 ill review data on the use of elotuzumab and daratumumab and provide a foundation for their use in cu
58 luated a mix-and-deliver (MD) formulation of daratumumab and rHuPH20 (DARA-MD) administered by subcut
60 ib, carfilzomib, lenalidomide, pomalidomide, daratumumab, and an alkylating agent and had disease ref
63 ated the potential of alpha-RIT with (212)Pb-Daratumumab (anti-CD38), in both in vitro and in vivo mo
64 ated the potential of alpha-RIT with (212)Pb-daratumumab (anti-hCD38), in both in vitro and in vivo m
66 , the dose-escalation phase, we administered daratumumab at doses of 0.005 to 24 mg per kilogram of b
69 s, daratumumab is clearly a breakthrough and daratumumab-based combinations might become the preferre
77 gression-free survival benefit compared with daratumumab, bortezomib, and dexamethasone in relapsed o
78 ntly improved progression-free survival with daratumumab, bortezomib, thalidomide, and dexamethasone
81 Patients received 1800 mg of subcutaneous daratumumab co-formulated with 2000 U/mL recombinant hum
83 after three days of incubation with (212)Pb-Daratumumab compared to (212)Pb-Isotypic Control or cold
85 bserved after 3 d of incubation with (212)Pb-daratumumab, compared with (212)Pb-isotypic control or c
87 ANDROMEDA study (NCT03201965) is evaluating daratumumab-CyBorD vs CyBorD in newly diagnosed AL amylo
96 B-NHL, the targeting with anti-CD38 antibody daratumumab demonstrated highly improved anti-lymphoma e
98 8 patients with advanced AL receiving either daratumumab/dexamethasone (DD, n = 106) or daratumumab/b
103 Of these, 10 patients received the first daratumumab dose as a single infusion (16 mg/kg, day 1 c
105 d all patients who received all eight weekly daratumumab doses in cycles 1 and 2 and provided a pre-d
107 Conclusion: These results showed (212)Pb-Daratumumab efficacy on xenografted mice with significan
108 Patients received 6 28-day cycles of IV daratumumab, every week for cycles 1 and 2 and every 2 w
111 e chelator deferoxamine (DFO), or (89)Zr-DFO-daratumumab, for immunologic PET imaging of multiple mye
113 lopment of several CD38 antibodies including daratumumab (fully human), isatuximab (chimeric), and MO
114 nt-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the
115 s were enrolled and randomly assigned to the daratumumab group (n=368) or the control group (n=369).
116 patients (97 of 368 patients [26.4%] in the daratumumab group and 143 of 369 patients [38.8%] in the
117 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group
118 complete response or better was 47.6% in the daratumumab group and 24.9% in the control group (P<0.00
120 nfidence interval [CI], 65.0 to 75.4) in the daratumumab group and 55.6% (95% CI, 49.5 to 61.3) in th
121 grade 3 or 4 adverse events reported in the daratumumab group and the control group were thrombocyto
122 ression-free survival was not reached in the daratumumab group and was 7.2 months in the control grou
123 e rate of overall response was higher in the daratumumab group than in the control group (82.9% vs. 6
124 ree survival was significantly higher in the daratumumab group than in the control group; the 12-mont
125 f progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group.
126 not reached (95% CI 54.8-not reached) in the daratumumab group versus 34.4 months (29.6-39.2) in the
127 grade 3 or 4 were neutropenia (50.0% in the daratumumab group vs. 35.3% in the control group), anemi
128 patients to 102 [76%] of 134 patients in the daratumumab group) of the EORTC QLQ-C30 and of the disea
129 tumumab plus lenalidomide and dexamethasone (daratumumab group) or lenalidomide and dexamethasone alo
130 patients to 92 [69%] of 134 patients in the daratumumab group), and physical functioning domains (13
131 patients to 156 [65%] of 240 patients in the daratumumab group), role functioning (103 [53%] of 196 p
134 scontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were ident
135 A total of 24.2% of the patients in the daratumumab group, as compared with 7.3% of the patients
137 ere reported in 45.3% of the patients in the daratumumab group; these reactions were mostly grade 1 o
138 In contrast, the alpha-emitter 225Ac-DOTA-daratumumab had a dose-dependent effect, in which 0.925,
139 ith PGNMID who received at least one dose of daratumumab had a partial response, and four had a compl
145 myeloma, and trials for both elotuzumab and daratumumab have demonstrated significant activity when
146 ACI panobinostat, and 2 mAbs, elotuzumab and daratumumab, have been approved, incorporated into clini
147 r radioimmunotherapy using radiolabeled DOTA-daratumumab in a preclinical model of disseminated multi
150 or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexametha
151 -free survival was significantly longer with daratumumab in combination with bortezomib, melphalan, a
152 and prolonged progression-free survival with daratumumab in combination with bortezomib, thalidomide,
153 study evaluated subcutaneously administered daratumumab in combination with the recombinant human hy
155 ts Single-agent activity was seen when using daratumumab in refractory myeloma, and trials for both e
156 daratumumab was non-inferior to intravenous daratumumab in terms of efficacy and pharmacokinetics an
163 an survival of 55 d for 277.5 kBq of (212)Pb-daratumumab instead of 11 d for phosphate-buffered salin
165 uration on reagent red blood cells mitigates daratumumab interference with transfusion laboratory ser
175 changing the paradigm of MM management, and daratumumab is the first-in-class human monoclonal antib
181 t patients with newly diagnosed MM receiving daratumumab-ixazomib-dexamethasone, even after adjusting
182 igned 2:1 to carfilzomib, dexamethasone, and daratumumab (KdD) or carfilzomib and dexamethasone (Kd).
183 cation of an antibody composed of the native daratumumab labeled with the positron-emitting radionucl
185 e basis of this analysis, the combination of daratumumab, lenalidomide, and dexamethasone seems to be
187 and June 18, 2018, 886 were re-randomised to daratumumab maintenance (n=442) or observation (n=444).
188 in the VTd group) were randomly assigned to daratumumab maintenance (n=442) or observation only (n=4
194 as an important regulator of sensitivity to Daratumumab-mediated antibody-dependent cellular cytotox
195 This resulted in significant enhancement of daratumumab-mediated complement-dependent cytotoxicity.
196 showed that IFNgamma significantly increased daratumumab-mediated cytotoxicity, as measured both by (
197 her, these studies show a novel mechanism of daratumumab-mediated killing and a possible new therapeu
198 To evaluate the in vivo efficacy of (212)Pb-daratumumab, mice were engrafted subcutaneously with 5 x
199 To evaluate in vivo efficacy of (212)Pb-Daratumumab, mice were engrafted subcutaneously with 5.1
200 In a cohort of 102 patients treated with daratumumab monotherapy (16 mg/kg), we found that pretre
204 The efficacy and favorable safety profile of daratumumab monotherapy in multiple myeloma (MM) was pre
205 t frequent adverse events during maintenance daratumumab monotherapy in patients in the D-VMP group w
208 ents with relapsed/refractory myeloma from 2 daratumumab monotherapy studies were analyzed before and
209 sk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significan
213 yaluronidase PH20 or 16 mg/kg of intravenous daratumumab once weekly (cycles 1-2), every 2 weeks (cyc
216 rtial response (PR) after 2 cycles continued daratumumab, otherwise lenalidomide or bortezomib was ad
221 oietic stem-cell transplantation (HSCT) with daratumumab plus bortezomib, thalidomide, and dexamethas
223 ineligible NDMM, triplet therapy with either daratumumab plus lenalidomide and dexamethasone (D-Rd) o
224 ologous stem-cell transplantation to receive daratumumab plus lenalidomide and dexamethasone (daratum
226 significantly lower among those who received daratumumab plus lenalidomide and dexamethasone than amo
229 increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the
232 3 [47%] women) were randomly assigned to the daratumumab plus pomalidomide and dexamethasone group (n
233 patients were randomly assigned: 151 to the daratumumab plus pomalidomide and dexamethasone group an
234 ollow-up of 16.9 months (IQR 14.4-20.6), the daratumumab plus pomalidomide and dexamethasone group sh
235 al was 34.4 months (95% CI 23.7-40.3) in the daratumumab plus pomalidomide and dexamethasone group ve
236 reported here continue to support the use of daratumumab plus pomalidomide and dexamethasone in patie
237 to randomly assign patients (1:1) to receive daratumumab plus pomalidomide and dexamethasone or pomal
238 ith relapsed or refractory multiple myeloma, daratumumab plus pomalidomide and dexamethasone reduced
239 first study showing the clinical benefit of daratumumab plus standard of care in transplant-eligible
241 in vitro genome-wide CRISPR screens probing Daratumumab resistance, KDM6A as an important regulator
242 sion on MM cells from patients who developed daratumumab resistance, to approximately pretreatment va
243 t express CD38, which prompted evaluation of daratumumab's effects on CD38-positive immune subpopulat
245 t role for CD38 and CIP expression levels in daratumumab sensitivity and suggest that therapeutic com
248 t 7 d after administration of [(89)Zr]Zr-DFO-daratumumab showed prominent tumor uptake (27.7 +/- 7.6
250 ough treatment of multiple myeloma (MM) with daratumumab significantly extends the patient's lifespan
252 that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) an
253 ed using randomly permuted blocks to receive daratumumab subcutaneously (subcutaneous group) or intra
254 treatment for MM is the monoclonal antibody Daratumumab, targeting the CD38 receptor, which is highl
257 ponse study with the beta-emitter 177Lu-DOTA-daratumumab, the lowest tested dose, 1.85 MBq, extended
259 Conclusion: These results showed (212)Pb-daratumumab to have efficacy in xenografted mice, with s
263 -VTd versus VTd, and support the addition of daratumumab to standard regimens in patients with newly
267 -related reactions that were associated with daratumumab treatment were reported in 45.3% of the pati
273 reached (95% CI not evaluable [NE]-NE) with daratumumab versus 46.7 months (40.0-NE) with observatio
274 nd safety of carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone in pati
275 of induction/consolidation treatment (D-VTd/daratumumab vs D-VTd/observation, 10-5 [77.3% vs 70.7%]
276 .3% vs 70.7%] and 10-6 [60.7% vs 52.0%]; VTd/daratumumab vs VTd/observation, 10-5 [70.9% vs 51.2%] an
277 (hazard ratio for progression or death with daratumumab vs. control, 0.39; 95% confidence interval,
278 The overall hematologic response rate to daratumumab was 76%, including CR in 36% and very good p
286 tro and in vivo evaluation of [(89)Zr]Zr-DFO-daratumumab was performed using CD38(+) human myeloma MM
292 otherapy with anti-CD38 monoclonal antibody (daratumumab) was proposed with a clinical and biological
294 myeloma (MM) include the anti-CD38 antibody daratumumab, which, in addition to its inherent cytotoxi
295 on, R140G, conferred selective resistance to daratumumab, while retaining sensitivity to isatuximab.
300 sought to determine whether the addition of daratumumab would significantly reduce the risk of disea