Positive results for POLLUX study of daratumumab combined with lenalidomide and dexamethasone for treatment of multiple myeloma published in NEJM.- Janssen Biotech

The POLLUX data of daratumumab combined with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) were presented at the 21st Congress of the European Hematology Association (EHA) in June. Daratumumab from Janssen Biotech was granted a Breakthrough Therapy Designation (BTD) from the 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 and dexamethasone, 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. 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 recently published in the New England Journal of Medicine.The positive data from the Phase III POLLUX study has now also been published in the New England Journal of Medicine.

See- "Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma"- Meletios A. Dimopoulos, M.D., Albert Oriol, M.D., Hareth Nahi, M.D.et al., N Engl J Med 2016; 375:1319-1331October 6, 2016DOI: 10.1056/NEJMoa1607751 .