NEJM publishes CASTOR study of daratumumab, bortezomib, and dexamethasone for Multiple Myeloma- Genmab A/S + Janssen Biotech

Genmab A/S announced that The New England Journal of Medicine has published data from the Phase III CASTOR (MMY3004) study of daratumumab. The CASTOR data were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting and the 21st Congress of the European Hematology Association (EHA). Daratumumab was granted a Breakthrough Therapy Designation (BTD) from the FDA based on these data in July 2016. The Phase III CASTOR study included 498 patients who had relapsed or refractory multiple myeloma. Patients were randomized to receive either daratumumab combined with subcutaneous bortezomib (a type of chemotherapy, called a proteasome inhibitor) and dexamethasone (a corticosteroid), or bortezomib and dexamethasone alone.

The study met the primary endpoint of improving progression free survival (PFS); Hazard Ratio (HR) = 0.39, p<0.001. the median pfs for patients treated with daratumumab has not been reached compared to median pfs of 7.2 months for patients who did not receive daratumumab. the overall response rate was 82.9 for patients treated with daratumumab versus an overall response rate of 63.2 in the group that did not receive daratumumab. the rate of very good partial response or better was also higher for the group treated with daratumumab 59.2 vs 29.1. the most common grade 3 or 4 adverse events in patients treated with daratumumab in combination with bortezomib and dexamethasone compared to those who only received bortezomib and dexamethasone were thrombocytopenia 45.3 vs 32.9 anemia 14.4 vs 16.0 and neutropenia 12.8 vs 4.2. daratumumab-associated infusion-related reactions were reported in 45.3 of patients were mostly grade 1 2 and occurred predominantly during the first infusion. this is consistent with the reported safety profile of daratumumab monotherapy and background bortezomib dexamethasone therapy.>

See- "Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma"- Antonio Palumbo, M.D., Asher Chanan-Khan, M.D., Katja Weisel, M.D., Ajay K. Nooka, M.D., et., al. for the CASTOR Investigators-N.Engl J Med 2016; 375:754-766August 25, 2016DOI: 10.1056/NEJMoa1606038.