Results

Genmab gains on promising early success for daratumumab PhIII in multiple myeloma, but questions linger

CD38 (ectodomain fragment) enzyme. Target of the monoclonal antibody drug daratumumab, used for the treatment of multiple myeloma. 3D rendering based on protein data bank entry 5f1k. (Shutterstock)

Shares of Copenhagen-based Genmab surged Thursday morning as investigators declared that its late-stage combo drug using daratumumab (Darzalex) hit the primary endpoint for treating multiple myeloma as a frontline therapy at the interim readout stage. Researchers now plan to unblind the data as Genmab {CPH: $GEN} and J&J $JNJ hustle along with a new marketing application.

Genmab CEO Jan van de Winkel

Genmab shares $GEN shot up 8% on the news.

The investigators now plan to unblind the data on the recommendation of the data monitoring group. In the study, daratumumab was combined with bortezomib, melphalan and prednisone (VMP) and compared to a group taking only VMP. The relevant data from Genmab and its Big Pharma partner J&J:

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.

Sally Church, a noted science writer specializing in oncology, remarked that the data may be more relevant in the European rather than the US market.

Genmab CEO Jan van de Winkel has been an exuberant advocate of the drug’s megablockbuster potential in cancer, particularly if it jumps to solid tumors from blood cancers.

“The interim results of the ALCYONE study yet again illustrate the potential of daratumumab in multiple myeloma in combination with existing treatment regimens; this time with VMP in the front line setting.  We are very pleased with the outcome of the pre-planned interim analysis in this study, which adds further to our hope that daratumumab could potentially become the critical driver redefining combination treatment in multiple myeloma,” said van de Winkel in a prepared statement.



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