Adding daratumumab (dara) to pomalidomide and dexamethasone (pom-dex) improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM), according to study results published in The Lancet Oncology.
The phase 3 APOLLO trial (ClinicalTrials.gov Identifier: NCT03180736) included 304 patients with relapsed/refractory MM who were treated at 48 academic centers and hospitals across 12 European countries.
The patients were randomly assigned to receive dara plus pom-dex (151 patients) or pom-dex only (153 patients).
At a median follow-up of 16.9 months, disease progression or death had occurred in 56% of patients in the dara arm and 69% of patients in the pom-dex arm.
The median PFS was 12.4 months in the dara arm and 6.9 months in the pom-dex arm (hazard ratio, 0.63; 95% CI, 0.47-0.85; P =.0018).
At the time of the PFS analysis, 32% of patients in the dara arm and 33% of patients in the pom-dex arm had died. Follow-up for long-term overall survival is ongoing.
The overall response rate was 69% in the dara arm and 46% in the pom-dex arm. The complete response rate was 25% and 4%, respectively, and the rate of minimal residual disease negativity was 9% and 2%, respectively.
The median time to first response was 1 month in the dara arm and 1.9 months in the pom-dex arm. The median duration of response was not reached and 15.9 months, respectively.
The most common grade 3/4 adverse events (AEs; in the dara and pom-dex arms, respectively) were neutropenia (68% vs 51%), anemia (17% vs 21%), and thrombocytopenia (17% vs 18%).
Serious AEs were reported in 50% of patients in the dara arm and 39% of patients in the pom-dex arm. Pneumonia occurred in 15% and 8%, respectively, and the incidence of respiratory tract infections was 12% and 9%, respectively.
The rate of fatal treatment-related AEs was 7% in both arms.
“[Dara plus pom-dex] is associated with a short administration duration for subcutaneous daratumumab and a low frequency of associated infusion-related reactions and injection-site reactions,” the study authors wrote. “The efficacy benefits of daratumumab plus pomalidomide and dexamethasone and the favorable administration characteristics of subcutaneous daratumumab make this a promising and convenient treatment option for patients with previously treated multiple myeloma.”
Disclosures: This research was supported by Janssen Research and Development and the European Myeloma Network. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Dimopoulos MA, Terpos E, Boccadoro M, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812. doi:10.1016/S1470-2045(21)00128-5