Results from a Phase 3 clinical trial show a 61% decrease in the risk of disease progression or death in patients with multiple myeloma treated with the immunotherapy daratumumab (Darzalex) combined with Bortezomib-Dexamethasone .
The data, from the study MMY3004 (Castor), was presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting and at the 21st Annual Congress of European Hematology Association (EHA).
“These compelling Phase 3 results demonstrate that a regimen built on daratumumab deepens clinical responses and help to underscore its potential for multiple myeloma patients who have been previously treated,” said Dr. Antonio Palumbo of the Department of Oncology, Division of Haematology at the University of Torino, in a press release.
When compared to bortezomib and dexamethasone alone, daratumumab also significantly increased the rates of complete response from 9% to 19%; and doubled the rates of very good partial response, from 29% to 59%.
The therapy is a product of Janssen Pharmaceutical Companies of Johnson & Johnson.
Jane Griffiths, Company Group Chairman of Janssen in Europe, the Middle East and Africa, said the company is extremely encouraged for “remarkable” interim results.
“The findings provide an important insight into the effect daratumumab can have in combination with established regimens, and illustrate the promise of this immunotherapy in earlier lines of treatment,” Griffiths said.
The Phase 3, multinational, open-label and randomized, active-controlled study included 498 patients with multiple myeloma: 63% of patients had received a prior treatment with bortezomib; 76% received prior treatment with an immunomodulatory agent; and 48% received prior treatment with a proteasome inhibitor (such as bortezomib) and an immunomodulatory agent.
Based on the results, Janssen Pharmaceutical Companies of Johnson & Johnson will now begin talks with regulation agencies to continue therapy development.