Janssen, a Johnson & Johnson division, said a combination therapy with DARZALEX slashed the risk of disease progression or death by 50 percent in newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplantation.
“These findings strongly support this DARZALEX frontline regimen as a new standard of care for these patients," said the lead study investigator Maria-Victoria Mateos.
The phase 3 ALCYONE study on 706 newly diagnosed multiple myeloma patients aimed to prove the safety and efficacy of the drug in combination with VMP (bortezomib, melphalan, and prednisone) regimen versus VMP alone.
Along with slicing the disease progression or death risk, the DARZALEX-VMP arm proved a 91 percent overall response rate versus the 74 percent in the VMP arm. Patients also had a higher stringent complete response (18 percent vs. 7 percent), very good partial response (71 percent vs. 50 percent), and complete response (43 percent vs. 24 percent), the company said.
As to adverse effects, 42 percent of patients in the DARZALEX-VMP arm experienced a serious adverse event vs. 33 percent in the VMP arm while 28 percent of patients experienced infusion reactions with Janssen's drug. As for Grade 3/4 treatment-emergent adverse effects, neutropenia and thrombocytopenia were the most common, the company said.
"DARZALEX offers compelling and consistent clinical benefit across all lines of therapy in multiple myeloma. These latest results convey the promise of DARZALEX in newly diagnosed patients for whom the initial therapy is most critical for long-term survival," said Sen Zhuang, vice president of Janssen’s Oncology Clinical Research.
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