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J&J's multiple myeloma drug combo cuts risk of disease progression by 50%

Johnson & Johnson's Darzalex combination regimen reduced the risk of disease progression or death by 50% in a phase 3 trial in multiple myeloma patients.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.

The drug was being evaluated in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

At a median follow-up of 16.5 months, the combination therapy reduced the risk of disease progression or death by 50% compared to treatment with just bortezomib, melphalan and prednisone.

The median progression-free survival for Darzalex combination had not yet been reached, compared to an estimated median progression-free survival of 18.1 months for patients who received just bortezomib, melphalan and prednisone.

In addition, the combination improved the overall response rates to 91%, compared to 74% for just bortezomib, melphalan and prednisone. The complete response rate was 18% for the Darzalex combination versus 7% for treatment with bortezomib, melphalan and prednisone.

J&J's unit Janssen Research & Development LLC submitted a supplemental biologics license application to the U.S. Food and Drug Administration and an application to the European Medicines Agency for the combination regimen in November.