International Journal of Hematology

DOI: 10.1007/s12185-019-02704-z Pages: 1-8

Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials

1. National and Kapodistrian University of Athens, Alexandra Hospital, Department of Clinical Therapeutics

2. University of Nantes

3. Nagoya City University Hospital

4. National Taiwan University Hospital

5. National Hospital Organization Disaster Medical Center of Japan

6. National University Health System, National University Cancer Institute

7. National University of Singapore, Cancer Science Institute of Singapore

8. Amgen Inc.

9. Gachon University College of Medicine, Gil Medical Center

Correspondence to:
Meletios A. Dimopoulos
Tel: 302132162541
Email: mdimop@med.uoa.gr

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Abstract

Carfilzomib is an irreversible proteasome inhibitor used for the treatment of relapsed and/or refractory multiple myeloma (RRMM). We evaluated the efficacy and safety of carfilzomib in subgroups of Asian patients in the randomized phase 3 ENDEAVOR and A.R.R.O.W. trials. In ENDEAVOR, patients received carfilzomib twice-weekly (56 mg/m2) plus dexamethasone (Kd; n = 56) or bortezomib plus dexamethasone (Vd; n = 57). In A.R.R.O.W., patients received carfilzomib once-weekly (70 mg/m2, n = 30) or twice-weekly (27 mg/m2, n = 15) plus dexamethasone. Median progression-free survival (PFS) among Asian patients in ENDEAVOR was longer with Kd than with Vd (14.9 versus 8.8 months; HR 0.599); the overall response rate (ORR) was 80.4% versus 70.2%. Median overall survival (Kd versus Vd) was 47.6 versus 38.8 months (HR 0.856). Median PFS among Asian patients in A.R.R.O.W. was longer for once-weekly versus twice-weekly Kd (16.0 versus 8.4 months; HR 0.628); ORR was 76.7% versus 53.3%. Rates of grade ≥ 3 adverse events were 89.1% (Kd) and 89.5% (Vd) in ENDEAVOR, and 76.6% (once-weekly Kd) versus 73.3% (twice-weekly Kd) in A.R.R.O.W. Overall, carfilzomib had a favorable benefit-risk profile across both dosing regimens [once-weekly (Kd 70 mg/m2) and twice-weekly (Kd 56 mg/m2)] in Asian patients with RRMM, which was consistent with the results of both parent studies.

Trial registration ClinicalTrials.gov: NCT01568866, NCT02412878.

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