PIII APOLLO RCT (n=304) found improved progression free survival with daratumumab plus pomalidomide and dexamethasone vs pomalidomide and dexamethasone alone at median follow up of 16.9 months (12.4 vs 6.9 months, HR 0.63, 95%CI 0.47-0.85) .
PIII APOLLO study has finished recruiting and is on course to collect primary outcome data by Jun 21 .
PIII APOLLO study (NCT03180736; MMY3013) is still recruiting. Collection of primary outcome data expected to complete Jun 21 .
Approval in the US was based on data from the Phase Ib (EudraCT2013-003491-12; 54767414MMY1001; NCT01998971) EQUULEUS study (n=103), which commenced Feb 2014. Patients in the study received 16 mg/kg daratumumab in combination with pomalidomide and dexamethasone. The ORR in the study was 59% (95% CI: 49.1%, 68.8%), with very good partial response (VGPR) achieved in 28% of patients. Complete response (CR) was achieved in 6% of patients and stringent CR (sCR) was achieved in 8% of patients. The median time to response was 1 month (range: 0.9 to 2.8 months). The median duration of response was 13.6 months (range: 0.9+ to 14.6+ months). The most frequent adverse reactions (>20%) in the study were: infusion reactions (50%), diarrhoea (38%), nausea (30%), vomiting (21%), fatigue (50%), pyrexia (25%), upper respiratory tract infection (50%), muscle spasms (26%), cough (43%) and dyspnoea (33%). The overall incidence of serious adverse reactions was 49% [2,3].
European Myeloma Network and Janssen initiated a PIII trial to evaluate daratumumab in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma who have previously been treated with an immunomodulatory drug and a proteasome inhibitor (EudraCT2017-001618-27; APOLLO; MMY3013). The primary endpoint of the study is PFS. Patients will be randomised 1:1 to either receive daratumumab in combination with pomalidomide and dexamethasone, or pomalidomide and dexamethasone alone. The trial is designed to confirm results from the MMY1001 (EQUULEUS) study. The trial will enrol approximately 354 patients. Enrolment is underway in Greece and is expected to extend to other European countries (not UK) .