Genmab announced that its partner Janssen Biotech will launch three novel studies to investigate the effect of Darzalex (daratumumab) in patients with multiple myeloma. The Danish company says its agreement grants Janssen — based in Titusville, New Jersey — authorization to exclusively develop, produce and market Darzalex.
The studies, to start later anytime between July 2017 and early 2018, include a Phase 3 trial investigating Darzalex in patients with smoldering multiple myeloma; a Phase 3 trial comparing subcutaneous and intravenous administration of Darzalex in patients with relapsed and refractory multiple myeloma; and a Phase 2 trial investigating subcutaneous Darzalex combined with standard of care for patients with frontline and relapsed multiple myeloma.
“Janssen’s expansive development plans for daratumumab emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients,” Genmab CEO Jan van de Winkel said in a press release.
Darzalex is a human IgG1k monoclonal antibody which acts by blocking CD38, a protein that has increased expression at the surface of myeloma cancer cells. When Darzalex binds to CD38, it enhances the body’s immune system and jump-starts inflammatory processes to attack and eliminate cancer cells.
Both U.S. and European regulatory agencies have approved Darzalex, in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, to treat multiple myeloma patients who have received at least one prior therapy. It’s also approved as a monotherapy for those who have received at least three prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who do not respond to both.
Previous trials have shown that combo therapy of Darzalex with Revlimid and dexamethasome in myeloma patients with a median of one prior therapy reduced the risk of disease progression or mortality by 63 percent. Combining Darzalex to Velcade and dexamethasone in patients who received a median of two prior therapies cut this risk by 61 percent. Five Phase 3 studies are now ongoing to assess Darzalex in patients with relapsed and frontline multiple myeloma.