Johnson & Johnson group Janssen has unveiled new data showing that the addition of Darzalex to the regimen of bortezomib, melphalan and prednisone (VMP) cut the risk of disease progression or death by 50 percent in patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation.

Results from the Phase III ALCYONE trial, presented at the American Society of Hematology (ASH) annual meeting in Atlanta, show that, at a median follow-up of 16.5 months, median progression-free survival (PFS) for the Darzalex-based regimen had not yet been reached compared to an estimated median PFS of 18.1 months for patients given VMP alone.

Also of note, Darzalex significantly improved overall response rates compared to VMP alone (91 percent versus 74 percent), including more than doubling rates of stringent complete response (18 percent vs 7 percent) and boosting complete response or better (43 percent vs 24 percent).

“Darzalex offers compelling and consistent clinical benefit across all lines of therapy in multiple myeloma,” said Sen Zhuang, vice president, Oncology Clinical Research, Janssen R&D. “These latest results convey the promise of Darzalex in newly diagnosed patients for whom the initial therapy is most critical for long-term survival.”

Regulators on both sides of the Atlantic are currently reviewing Janssen’s application, filed in November, seeking permission to market Darzalex for this patient population.

In 2015 Darzalex became the first CD38-directed antibody to receive regulatory approval to treat relapsed or refractory multiple myeloma.