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ASCO 2016: CASTOR study -- Dr. Katja Weisel

Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study.

06.06.16

Author(s): 

Antonio Palumbo, Asher Alban Akmal Chanan-Khan, Katja Weisel, Ajay K. Nooka, Tamas Masszi, Meral Beksac, Ivan Spicka, Vania T.M. Hungria, María-Victoria Mateos, Tomer Martin Mark, Ming Qi, Jordan Mark Schecter, Himal Amin, Xiang Qin, William Deraedt, Tahamtan Ahmadi, Andrew Spencer, Pieter Sonneveld; University of Torino, Torino, Italy; Mayo Clinic Florida, Jacksonville, FL; Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Tubingen, Germany; Emory University Winship Cancer Center, Atlanta, GA; Fovarosi Onkormanyzat Szent Laszlo Korhaza, Hematologia, Budapest, Hungary; Ankara Universitesi Tip Fakultesi, Ankara, Turkey; Vseobecna Fakultni Nemocnice V Praze, Prague, Czech Republic; Irmandade da Santa Casa de Misericordia de São Paulo, Sao Paulo, Brazil; University Hospital of Salamanca/IBSAL, Salamanca, Spain; New York Presbyterian Weill Cornell Hospital, New York, NY; Janssen Research and Development, LLC, Raritan, NJ; Janssen Research & Development, Raritan, NJ; Janssen Research & Development LLC, Raritan, NJ; Johnson and Johnson, Philadelphia, PA; Alfred Hospital, Melbourne, Australia; Erasmus Medical Center, Rotterdam, Netherlands

Abstract Disclosures

Background: Daratumumab (D), a human anti-CD38 IgGκ mAb, induces deep and durable responses with a favorable safety profile in RRMM pts. We report a pre-specified interim analysis of the first randomized controlled study of D (CASTOR; NCT02136134). 

Methods: Pts with ≥1 prior line of therapy were randomized (1:1) to 8 cycles (q3w) of bortezomib (V)/dexamethasone (d) (V: 1.3 mg/m2sc on Days 1, 4, 8, 11; d: 20 mg po on Days 1, 2, 4, 5, 8, 9, 11, 12) ± D (16 mg/kg iv qw in Cycles 1-3, Day 1 of Cycles 4-8, then q4w until progression). Primary endpoint was PFS. 

Results: 498 pts (DVd, 251; Vd, 247) were randomized. Baseline demographics and disease characteristics were well balanced. Pts received a median of 2 prior lines of therapy (range 1-10). 66% received prior V; 76% received prior IMiD; 48% received prior PI and IMiD; 33% were IMiD-refractory; 32% were refractory to last line of prior therapy. With median follow-up of 7.4 months, D significantly improved median PFS (61% reduction in risk of progression) and TTP for DVd vs Vd (Table). D significantly increased ORR (83% vs 63%, P<0.0001), and doubled rates of ≥VGPR (59% vs 29%, P<0.0001), and ≥CR (19% vs 9%, P= 0.0012) for DVd vs Vd, respectively; median duration of response was NR vs 7.9 months, respectively. Most common (>25%) AEs (DVd/Vd) were thrombocytopenia (59%/44%), peripheral sensory neuropathy (47%/ 38%), diarrhea (32%/22%) and anemia (26%/31%). Most common grade 3/4 AEs (>10%) were thrombocytopenia (45%/33%), anemia (14%/16%), neutropenia (13%/4%). 7%/9% of pts discontinued due to a TEAE. D-associated infusion-related reactions (45% of pts) mostly occurred during the first infusion; most were grade 1/2 (grade 3/4, 9%/0%). 

Conclusions: D significantly improved PFS, TTP, and ORR in combination with Vd vs Vd alone. DVd doubled both VGPR and sCR/CR rates vs Vd alone. Safety of DVd is consistent with the known safety profile of D and Vd. The addition of D to Vd should be considered a new standard of care for RRMM pts currently receiving Vd alone.

Clinical trial information: NCT02136134


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