At an educational session at the 2015 American Society of Hematology Annual Meeting and Exposition, Sagar Lonial, MD, of Emory University, Atlanta, elaborated upon this topic. The pooled analysis of daratumumab (Darzalex) monotherapy, he said, “demonstrated significant activity and, not only this, but very prolonged duration of remission and overall survival in patients, even beyond the time when their response to anti-CD38 antibody is gone. This suggests that immunomodulation may be an important part of the long-term outcome of patients.”

Thierry Facon, MD, of Lille University Hospital in France, who is co-principal investigator for the front-line trial of daratumumab, said in an interview with The ASCO Post that he is eager to have access to the drug in France. “This drug is important for our patients,” stated Dr. Facon.

Dr. Facon commented that oncologists will no doubt want to use daratumumab off-label. It is currently indicated only as a single agent in patients who have received at least three lines of treatment. “The pressure for this will be immense,” he predicted. “The experts will say we have to stick to the indication for which it is approved, but I know there will be pressure from patients.”

Whether daratumumab will work best with lenalidomide (Revlimid) or pomalidomide (Pomalyst) remains unclear, experts said. “This is an incredibly active combination as well and speaks to the immune-mediated inflammatory disease/antibody interaction, which really does seem to enhance the activity of both agents over time,” Dr. Lonial said.

As a single agent, however, daratumumab does have a place, Dr. Facon added. “The best use will not be as a single agent; however, this still gives a 30% response in patients who have failed everything. This is an unmet need.” ■

Disclosure: Dr. Lonial is a consultant for Millennium, Celgene, Novartis, Bristol-Myers Squibb, Onyx, and Janssen. Dr. Facon is a member of the Board of Directors or advisory committee and the speakers bureau for Celgene.