Phase III trial of Darzalex (daratumumab) + Revlimid + dexamethasone meets primary PFS endpoint in multiple myeloma- Genmab

Genmab A/S announced that the Phase III POLLUX study (MMY3003) of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis. Patients who received treatment with daratumumab in combination with lenalidomide and dexamethasone had a 63% reduction in risk of their disease progressing, compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 18.4 months for patients who received lenalidomide and dexamethasone alone.

Overall, the safety profile of daratumumab in combination with lenalidomide and dexamethasone was manageable and consistent with the known safety profile of the lenalidomide and dexamethasone combination, with the ongoing Phase II study, GEN503, which evaluated safety and efficacy of daratumumab in combination with lenalidomide and dexamethasone as well as daratumumab monotherapy. Based on the results at the pre-planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC), it was recommended that the data be unblinded.

The trial results are also aimed to be presented at the 21st Congress of the European Hematology Association (EHA) as well as submitted for publication in a peer-reviewed journal. Analysis of the safety and efficacy data is underway and will be shared with the health authorities.