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Dose-dependent efficacy of daratumumab (DARA) as monotherapy in patients with relapsed or refractory multiple myeloma (RR MM).
J Clin Oncol 32:5s, 2014 (suppl; abstr 8513)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Pts with RR MM received DARA for 9 wks in doses of 0.005-24mg/kg in the GEN501 dose-escalation part (Lokhorst: EHA 2013 abstract S576). The purpose of the GEN501 expansion part, which has completed enrollment, was to evaluate safety and efficacy of 2 doses of DARA for up to 24 mths using alternate dose schedules. Methods: Pts ≥18 yrs, RR to at least 2 prior lines of therapy, incl. IMiDs and proteasome inhibitors, and ineligible for ASCT were enrolled at 2 dose levels: A: 8mg/kg +/- pre-dose (10mg) wkly for the first 8 infusions.B: 16mg/kg without pre-dose with a 3-wk washout period between the first 2 doses followed by 7 wkly doses. Then all pts were dosed every 2nd wk for 16 wks followed by dosing every 4th wk until disease progression, toxicity or for max 24 mths. Results: Data from 30 pts in the 8mg/kg cohort and 15 pts in the 16mg/kg cohort recruited into the GEN501 expansion part are presented. Median age was 58.2 (35.1-76.9) and 64.1 (50.5-75.0) years, prior treatment lines were 5 (3-11), and 4 (2-8) and time since diagnosis was 5.5 (2.1-15.2) and 7.1 (0.4-13.3) years, respectively. Median number of DARA infusions was 10.5 vs 7.0, reflecting the more recent initiation of the 16mg/kg cohort. Infusion times were 3.5 vs 3.4 hours in the 8 and 16mg/kg groups, respectively. Safety: No dose-related increase in adverse events (AEs) was observed. Most common AEs reported (in ≥20% of all pts) were pyrexia, allergic rhinitis, fatigue, upper respiratory tract infection, diarrhea, dyspnea and cough. Only mild (Gr 1 and 2) infusion-related reactions (IRRs) were reported with 27% in the 16mg/kg group vs 20% in the 8mg/kg group. 2 SAEs, 1 in each group, were assessed as related to DARA (1 thrombocytopenia, 1 lymphocytopenia). One pt was withdrawn after 1st full dose due to thrombocytopenia Gr 3. Omission of the pre-dose increased neither the incidence nor the severity of IRRs. Conclusions: DARA monotherapy in RR MM pts resulted in high single agent activity when administered at 16 mg/kg (46% ORR). The safety profile was manageable. Full response data will be presented at the meeting incl. bone marrow assessments. Clinical trial information: NCT00574288.
A PR or better. B 2 pts only had 1st dose at data cutoff.
Abstracts by Henk M. Lokhorst:
Presentations by Henk M. Lokhorst:
Dose-dependent efficacy of daratumumab (DARA) as monotherapy in patients with relapsed or refractory multiple myeloma (RR MM).Session: Myeloma (Oral Abstract Session)