Johnson & Johnson's immunotherapy Darzalex produced a significant response in over half of the patients treated for a type of intermediate or high-risk smoldering multiple myeloma — a precursor to multiple myeloma — preliminary data of a phase 2 trial showed.
Darzalex, or daratumumab, is already approved as a monotherapy to treat multiple myeloma patients who have received at least three prior lines of therapy.
The Centaurus study evaluated Darzalex as a monotherapy in three dosing schedules in 123 patients with smoldering multiple myeloma.
The overall response rate was numerically higher in the long-intense dosing arm at 56%, as compared to the other cohorts of the study, with a median follow-up of 15.8 months. Estimated 12-month progression-free survival rates were 95%, 88% and 81% in the long-intense, intermediate and short-intense dosing schedules, respectively.
The monotherapy's safety was manageable in the trial, and comparable to Darzalex's in the relapsed or refractory multiple myeloma setting.
At the clinical cut-off time, one death due to disease progression was confirmed in the short-intense dosing arm.
These results serve as the basis for a phase 3 study which is currently enrolling patients for Darzalex.
Meanwhile, updated data from the phase 1b Pavo study showed administering Darzalex as an under-the-skin injection was effective with shorter infusion times and lower risk of infusion reactions compared with intravenous administration of the medicine in multiple myeloma patients.
Darzalex is being developed by J&J's Janssen Biotech, Inc. unit as part of an August 2012 exclusive worldwide license agreement with Genmab A/S.
Darzalex was first approved by the U.S. Food and Drug Administration in November 2015 as a monotherapy treatment for patients with multiple myeloma — a cancer that forms in a type of white blood cell called a plasma cell. Plasma cells help to fight infections by making antibodies that recognize and attack germs.
