Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial

Evangelos Terpos, MD, PhD
Department of Clinical Therapeutics, Plasma Cell Dyscrasias Unit, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

The second is the APOLLO study that was published in the June issue of Lancet Oncology. This was a phase 3 study which compared the combination of daratumumab plus pomalidomide and dexamethasone (DaraPomDex) versus pomalidomide and dexamethasone (PomDex) alone in patients with previously treated multiple myeloma. This is a European Myeloma Network supported study, which was performed at 48 academic centers and hospitals across 12 European countries.

Eligible patients were 18 years or older, had relapsed or refractory multiple myeloma with measurable disease, had an Eastern Cooperative Oncology Group performance status of 0-2, had at least one previous line of therapy, including lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if only one previous line of therapy was received. All patients received oral pomalidomide (4 mg, once daily on days 1-21) and oral dexamethasone (40 mg once daily on days 1, 8, 15, and 22; 20 mg for those aged 75 years or older) at each 28-day cycle. The DaraPomDex group received daratumumab (1800 mg sc or 16 mg/kg intravenously) weekly during cycles 1 and 2, every 2 weeks during cycles 3-6, and every 4 weeks thereafter until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival in the intention-to-treat population.

Between June 22, 2017, and June 13, 2019, 304 patients (median age 67 years) were randomly assigned to the DaraPomDex (n=151) or PomDex (n=153) groups. At a median follow-up of 16·9 months (IQR 14·4-20·6), the DaraPomDex group showed improved PFS compared with the PomDex group (median 12.4 months [95% CI 8.3-19.3] versus 6.9 months [5.5-9.3]; hazard ratio 0.63 [95% CI 0.47-0.85], p=0.0018).

The most common grade 3 or 4 adverse events were neutropenia (68% versus 51% in DaraPomDex and PomDex arms, respectively), anemia (17% versus 21%), and thrombocytopenia (17% versus 18%), pneumonia (15% versus 8%) and lower respiratory tract infection (12% versus 9%). Treatment-emergent deaths were reported in 11 (7%) patients in both arms.

Professor Meletios A. Dimopoulos who is the first author of the publication talks to IMS Newsletter for the results of the APOLLO study.

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