European Commission (EC) extends approval for daratumumab to include myeloma patients who have received at least one prior therapy

European Commission (EC) has granted approval daratumumab for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with myeloma who have received at least one prior therapy.

The EC’s decision was based on data from the Phase 3 POLLUX (MMY3003) study, presented at ASCO 2016 and published in the New England Journal of Medicine, and Phase 3 CASTOR (MMY3004) study, presented at EHA 2016 and also published in the same scientific publication. The addition of daratumumab significantly reduced the risk of disease progression or death, by 63% in POLLUX and 61% in CASTOR, when combined with standard of care regimens (p<0.001 in both studies).

The safety profile of daratumumab in combination with standard of care regimens was consistent with daratumumab monotherapy studies and with that for the standard of care regimens. In combination with lenalidomide and dexamethasone (POLLUX), the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).1 Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2. In combination with bortezomib and dexamethasone (CASTOR) three of the most common grade 3 or 4 adverse events reported were thrombocytopenia (45.3%), anaemia (14.4%), and neutropenia (12.8%). Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of patients), and in 98.2% of these patients, they occurred during the first infusion.

“Data from both the CASTOR and POLLUX studies demonstrated improved progression-free survival and a reduction in disease progression or death compared to standard of care,” said Torben Plesner, M.D., Vejle Hospital, Vejle, Denmark, a daratumumab clinical trial investigator. “Together, these results show daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent has the potential to provide clinical benefit to patients after one or more lines of therapy.”