Daratumumab combination therapy tripled the minimal residual disease negativity rate among patients with multiple myeloma.
Janssen recently announced positive results from the phase 3 ALCYONE clinical trial, which demonstrated that daratumumab (Darzalex) plus bortezomib, melphalan, and prednisone (VMP) improved the clinical outcomes of patients with multiple myeloma (MM), according to a press release.
In patients with MM who were ineligible for autologous stem cell transplant, the daratumumab combination reduced the risk of disease progression or mortality by 50%, according to Janssen.
“These phase 3 results for Darzalex demonstrated clinically meaningful improvements with a manageable safety profile,” said lead investigator Maria-Victoria Mateos, PhD. “Selecting the right treatment regimen is critical for patients who are newly diagnosed, especially if they are transplant ineligible, as these patients tend to be older and more frail. These findings strongly support this Darzalex frontline regimen as a new standard of care for these patients.”
After a median follow-up of 16.5 months, daratumumab plus VMP slashed the risk of progression in half compared with VMP therapy, according to the release.
Daratumuab was also observed to increase overall response rates compared with VMP alone, with 91% of patients treated with combination therapy and 74% of patients treated with VMP achieving an overall response, according to the study.
The addition of daratumumab more than doubled the rate of stringent complete response from 7% with VMP to 18%. Janssen also found that daratumumab nearly doubled the complete response rate.
Minimal residual disease negativity rate was observed to triple among patients treated with the combination therapy compared with VMP alone, according to the study.
However, progression-free survival for the combination therapy has yet to be determined.
Common treatment-emergent events included neutropenia, thrombocytopenia, anemia, and pneumonia. The most common adverse events included pneumonia, anemia, bronchitis, lower respiratory tract infection, upper respiratory tract infection, febrile neutropenia, and cardiac failure.
In November 2017, Janssen submitted a supplemental Biologics Application for daratumumab plus VMP for patients with MM. If approved, this would be the fifth approval for daratumumab and the first approval as a first-line therapy, according to the release.
“Darzalex offers compelling and consistent clinical benefit across all lines of therapy in multiple myeloma,” said Sen Zhuang, MD, PhD, vice president, Oncology Clinical Research, Janssen Research and Development. “These latest results convey the promise of Darzalex in newly diagnosed patients for whom the initial therapy is most critical for long-term survival.”