Update From Phase III APOLLO Trial of Daratumumab-Based Therapy for Myeloma

By: Vanessa A. Carter, BS
Posted: Wednesday, February 23, 2022

Pieter Sonneveld, MD, PhD, of Erasmus University Medical Center Cancer Institute, Rotterdam, Netherlands, and colleagues evaluated the addition of subcutaneous daratumumab—a CD38-targeting, human IgGκ monoclonal antibody—to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Presented during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 2747), the results of the phase III APOLLO study suggest that the addition of daratumumab may improve progression-free survival with a consistent safety profile.

The study authors focused on 304 adults with relapsed or refractory multiple myeloma who received at least one prior therapy line and responded to treatment. Participants were randomly assigned 1:1 to receive pomalidomide and dexamethasone with (n = 151) or without (n = 153) subcutaneous daratumumab. Treatment was continued until disease progression or unacceptable toxicity.

Most patients in both the daratumumab (79.5%) and non-daratumumab (79.7%) arms were refractory to lenalidomide. At the median follow-up of 16.9 months, the median progression-free survival among patients given daratumumab was significantly higher than those who were not (12.4 vs. 6.9 months; P = .0018), with 18-month estimated rates of 42.1% and 25.5%, respectively. The median progression-free survival among participants who were refractory to lenalidomide was also improved among those treated with daratumumab (9.9 vs. 6.5 months).

Treatment-emergent adverse events of grade 3 or 4 were reported in 87.3% of patients given daratumumab and 82.0% of those not given daratumumab; neutropenia (67.8% vs. 50.7%), thrombocytopenia (17.5% vs. 18.0%), and anemia (16.8% vs. 21.3%) were the most common. Additionally, pneumonia of grade 3 or 4 was reported in 20 patients in the daratumumab group and 10 in the non-daratumumab group. Of note, serious adverse events were observed in 50.3% of participants given daratumumab and 39.3% of those who were not.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.

2021 ASH Annual Meeting & Exposition

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