| The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage. |
Treatment of relapsed/refractory multiple myeloma (RRMM) with subcutaneous daratumumab plus pomalidomide and dexamethasone (D-Pd) prolonged progression-free survival (PFS) compared with pomalidomide and dexamethasone (Pd) alone, according to the results of the phase 3 APOLLO study presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
“In the first phase 3 study of subcutaneous daratumumab given in combination [with] Pd significantly reduced the risk of progression or death by 37% vs Pd in patients with RRMM who had received at least 1 line of prior therapy,” Meletios A. Dimopoulos, MD, of the National Kapodistrial University of Athens in Greece, and presenter of the study, said.
Phase 1b data suggested that D-Pd could induce deep responses among patients with RRMM. It is currently approved by the US Food and Drug Administration (FDA) for the treatment of RRMM after at least 2 prior lines of therapy. The aim of this trial was to evaluate the safety and efficacy of D-Pd among patients with RRMM treated with 1 or more prior lines of therapy.
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The multicenter, open-label, phase 3 trial randomly assigned 304 patients with RRMM treated with at least 1 prior therapy to receive D-Pd or Pd. Previous treatment with an anti-CD38 agent or pomalidomide was not allowed. The primary endpoint was PFS, and secondary endpoints included overall response rate (ORR), very good partial response (VGPR) rates, minimal residual disease (MRD), and overall survival (OS).
The baseline characteristics were well balanced between groups. Median patient age was 68 years, and 65% of patients had standard cytogenetic risk. The majority of patients were refractory to lenalidomide (80%), and some were refractory to a proteasome inhibitor (48%) or both (42%).
The primary endpoint was met with a median follow-up of 16.9 months, as D-Pd treatment resulted in significantly prolonged PFS. The median PFS was 12.4 months with D-Pd compared with 6.9 months with Pd (hazard ratio, 0.63; 95% CI, 0.47-0.85; P =.0018). The PFS benefit of D-Pd was absorbed across most subgroups, including patients refractory to lenalidomide, refractory to various lines of therapy, at different disease stage, and those of older age.
The OS data were not yet mature at the time of presentation.
The ORR was also higher with D-Pd at 69% compared with 46% with Pd (P <.0001), with 24.5% and 3.9% of patients achieving CR, respectively. In addition, 51% of patients achieved at least a VGPR with D-Pd compared with 51% of patients who received Pd. MRD negativity was achieved by 9% and 2% of patients treated with D-Pd or Pd, respectively (P =.0102).
Treatment discontinuation due to adverse events (AEs) was low, at 2% and 3% with D-Pd and Pd, respectively. The most common grade 3 to 4 AEs that occurred more frequently with D-Pd were neutropenia, leukopenia, lymphopenia, febrile neutropenia, and pneumonia.
Dr Dimopoulos concluded by stating these data show that D-Pd “is an effective and convenient treatment for patients with RRMM who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor.”
Disclosure: The study that was the basis of this presentation was sponsored by the European Myeloma Network in collaboration with Janssen Research and Development, LLC.
Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.
Reference
Dimopoulos MA, Terpos E, Boccadoro M, et al. Apollo: phase 3 randomized study of subcutaneous daratumumab plus pomalidomide and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) alone in patients (pts) with relapsed/refractory multiple myeloma (RRMM). Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-9, 2020. Abstract 412.
