Denmark-based Genmab A/S released topline data from its Phase III MAIA trial of a drug it licensed to Johnson & Johnson’s Janssen, Darzalex (daratumumab). The drug is being evaluated in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone (DRd), compared to Revlimid and dexamethasone alone in patients newly diagnosed with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant.
The trial met its primary endpoint of improved progression-free survival (PFS) at a pre-planned interim analysis. There was a 45 percent decrease in the risk of progression or death in patients with Revlimid and dexamethasone (DRd). The median PFS for patients receiving Darzalex in combination with Rd wasn’t reached, compared to an estimated median PFS of 31.9 months for the patients who received Rd alone.
Based on the data, an Independent Data Monitoring Committee (IDMC) recommended Genmab release the interim data. Genmab will continue to analyze the safety and efficacy data. Janssen licensed Darzalex from Genmab in 2012. It plans to discuss submitting the combination to regulators, present the data at an upcoming medical conference and submit to a peer-reviewed journal.
Genmab licensed Darzalex to Janssen in 2012. Janssen has a worldwide license to develop, manufacture and commercialize Darzalex. There are ongoing trials for the drug, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Janssen either has ongoing trials or plans studies to evaluate the drug in other malignant and pre-malignant diseases, including NKT-cell lymphoma, myelodysplastic syndrome, B and T-ALL.
Darzalex has received two Breakthrough Therapy Designations from the US. Food and Drug Administration (FDA) as a monotherapy and in combination with other therapies.
Darzalex is approved in the U.S. in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for second-line treatment for multiple myeloma; in combination with pomalidomide and dexamethasone as third-line multiple myeloma, and as a monotherapy for multiple myeloma patients who receive three previous therapies, including a protease inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI, and an immunomodulatory agent who have shown disease progression on the last therapy.
“We are highly encouraged by this data as this is the fifth randomized study showing a profound benefit when adding daratumumab to standard of care treatments in multiple myeloma, and the second showing efficacy for patients with newly diagnosed multiple myeloma who are not eligible for ASCT,” said Jan van de Winkel, Genmab’s chief executive officer, in a statement. “As such, this data increases our hope that daratumumab may one day help even more patients at the outset of treatment of this disease.”
The results from this trial are good news. Darzalex had previously failed earlier-stage trials in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in non-small cell lung cancer, and with J&J’s PD-1 inhibitor JNJ-63723283 in multiple myeloma. Those trials were both terminated due to an increase in patient deaths.
In 2017, Darzalex brought in $1.24 billion, but van de Winkel has said that if it could get approval into other blood cancers and solid tumors, sales could top $9 billion.
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