Date: 2017-08-24
Type of
information: Results
phase: 3
Announcement: initiation of the trial
Company: Janssen Biotech - J&J (USA) Genmab (Denmark)
Product: daratumumab in combination with bortezomib, melphalan and prednisone
Action
mechanism:
- monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. The CD38 molecule is highly expressed on the surface of multiple myeloma cells. CD38 is also expressed on a number of other hematological tumors, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
Disease: front line multiple myeloma
Therapeutic
area: Cancer - Oncology
Country: Argentina, Australia, Belgium, Brazil, Bulgaria, Croatia, Czechia, Georgia, Germany, Greece, Hungary, Japan, Republic of Korea, Macedonia, Republic of The Former Yugoslav, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine ,UK, USA
Trial
details:
- The Phase III MMY3007 study (ALCYONE study) is a randomized, open-label, multicenter study. It will include approximately 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for stem cell transplantation (SCT). Patients will be randomized to receive either daratumumab combined with bortezomib (proteasome inhibitor ), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid), or bortezomib, melphalan and prednisone alone. The primary endpoint of the study is progression free survival (PFS). (NCT02195479)
Latest
news:
- • On August 24, 2017, Genmab announced topline results from the Phase III ALCYONE study (MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front line treatment for newly diagnosed patients who are not considered candidates for autologous stem cell transplantation (ASCT). The study met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.50 (95% CI 0.38-0.65), p < 0.0001). Treatment with daratumumab reduced the risk of disease progression or death by 50%, as compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with VMP has not been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone.
Overall, the safety profile of daratumumab in combination with VMP is consistent with the known safety profile of the VMP regimen and the known safety profile of daratumumab.
Based on the results at the pre-planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC), it was recommended that the data be unblinded. All patients will continue to be monitored for safety and overall survival. Further analysis of the safety and efficacy data is underway and Janssen Biotech, which licensed daratumumab from Genmab in 2012, will discuss with health authorities the potential for a regulatory submission for this indication. The data are expected to be submitted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal.
- • On July 19, 2014, Genmab announced that its partner, Janssen Biotech, plans to start a new Phase III study of daratumumab in multiple myeloma. The study (MMY3007) will compare daratumumab in combination with bortezomib, melphalan and prednisone to bortezomib, melphalan and prednisone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT). The study is planned to start in the fourth quarter of 2014.
- In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
Is
general: Yes
