Results from a Phase III study with Janssen’s blockbuster daratumumab could lead to its approval as a first-line treatment for patients with multiple myeloma.
Danish Genmab has announced today promising Phase III results for its antibody daratumumab, which made its stock rise by 11% shortly after the announcement. The antibody, licensed to Janssen and marketed as Darzalex, is expected to bring peak sales of up to $13Bn (€12Bn) a year, a figure that’s now closer given the released results.
In a trial that recruited 706 patients newly diagnosed with myeloma, daratumumab was administered along with VMP chemotherapy regime and compared to chemo alone. Results show that the antibody reduced the progression of the disease and death of the patients by 50%, meeting the primary endpoint of the trial.
Janssen has announced that, based on the results, it is planning to start discussions with regulatory agencies. And, as Endpoints reports, the drug could have a bigger market in Europe since VMP chemotherapy is used much more frequently than in the US.
Daratumumab acts by binding the CD38 antigen, highly expressed on the surface of multiple myeloma cells, and triggering the immune system to attack the tumoral cells. The antibody is currently being tested in five additional trials for multiple myeloma, with additional studies planned to test it in other tumor types that express CD38, such as NKT-cell lymphoma, amyloidosis, and solid tumors.
But while the antibody accumulates indications, the German MorphoSys is suing Janssen and Genmab for the ownership of the IP behind it. MorphoSys is developing an antibody that also targets the CD38 antigen and claims the IP overlaps. Given the massive expectations put on daratumumab, the court’s rule will make a big difference for the parties involved.
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