Data from Phase III POLLUX Study of Daratumumab Published in The New England Journal of Medicine
The New England Journal of Medicine published data from the Phase III POLLUX study of daratumumab in relapsed or refractory multiple myeloma
Study data initially presented at the 21st Congress of EHA
Copenhagen, Denmark; October 6, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today The New England Journal of Medicine has published data from the Phase III POLLUX (MMY3003) study of daratumumab. The POLLUX data were presented at the 21st Congress of the European Hematology Association (EHA) in June. Daratumumab was granted a Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) based on these data in July 2016.
The Phase III POLLUX study enrolled 569 patients who had relapsed or refractory multiple myeloma. Patients were randomized to receive either daratumumab combined with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid), or lenalidomide and dexamethasone alone. The study met the primary endpoint of improving progression-free survival (PFS) (Hazard Ratio (HR) = 0.37; 95% CI 0.27-0.52; p<0.001) for patients treated with daratumumab versus patients who did not receive daratumumab. 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. The overall response rate was 93% in the group of patients treated with daratumumab versus 76% in the group that did not receive daratumumab. The rates of very good partial response or better (76% vs 44%) and complete response or better (43% vs 19%) were also higher for the group treated with daratumumab. Of patients treated with daratumumab, 22% were minimal residual disease negative, versus 5% in those who did not receive daratumumab; negative minimal residual disease translated into improved outcomes. The most common grade 3 or 4 adverse events in patients treated with daratumumab in combination with lenalidomide and dexamethasone versus those who received only lenalidomide and dexamethasone were neutropenia (51.9% vs 37.0%), thrombocytopenia (12.7% vs 13.5%), and anemia (12.4% vs 19.6%). Daratumumab-associated infusion-related reactions occurred in 48% of patients, were mostly grade 1/2, and occurred predominantly during the first infusion. Overall, the safety profile was consistent with known toxicities of daratumumab monotherapy and combination therapy of lenalidomide and dexamethasone.
Data from another Phase III study (CASTOR) of daratumumab combined with subcutaneous bortezomib (a type of chemotherapy, called a proteasome inhibitor) and dexamethasone (a corticosteroid) compared with bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma was also recently published in the New England Journal of Medicine.1
"Following the publication of the Phase III CASTOR data, we are pleased that the positive data from the Phase III POLLUX study has now also been published in the New England Journal of Medicine," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "The data from this study formed the basis, along with data from the CASTOR study, of two regulatory submissions in August; the supplemental Biologics License Application submitted to the U.S. Food and Drug Administration and the submission of the variation to the Marketing Authorization to the European Medicines Agency."