Janssen Research & Development has announced positive results of  an interim analysis of a trial comparing the success and safety of the triple combo daratumumab, bortezomib and dexamethasone (dex) vs. bortezomib and dex alone in myeloma patients with relapsed or refractory disease. The interim analysis of the trial found that the daratumumab combo treatment regimen improved progression-free survival (PFS) compared with bortezomib and dexamethasone alone, achieving the primary study endpoint. The study will be stopped early. Study patients originally assigned to the standard treatment group (bortezomib plus dex) will be offered the option of receiving daratumumab following confirmed disease progression. All patients continue to be followed for long-term safety and overall survival.

"These results suggest daratumumab could potentially be used in combination with standard therapy in patients with relapsed or refractory multiple myeloma," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development. "We are especially proud that Janssen was involved in the development of two of the medicines in this trial, daratumumab and bortezomib."

The phase 3 of the CASTOR trial is a multinational, open-label, randomized, multicenter, active-controlled study in about 490 patients with relapsed or refractory multiple myeloma. Patients were randomized to receive either daratumumab combined with subcutaneous bortezomib (a proteasome inhibitor) and dexamethasone (a corticosteroid), or bortezomib and dexamethasone alone. Participants were treated until disease progression, unacceptable toxicity, or if they had other reasons to discontinue the study. The primary endpoint of the study is progression free survival.