- Clinical results presented on Tuesday will showcase Johnson & Johnson's strategy for expanding use of its multiple myeloma drug Darzalex, demonstrating the benefit of adding the antibody to a standard regimen for frontline treatment of certain patients with the blood cancer.
- "What we have tried to do with Darzalex is to put it into every regimen where it can add benefit," said Peter Lebowitz, global therapeutic area head of oncology at J&J's Janssen unit, told BioPharma Dive in an interview.
- That approach can be seen in data from the Phase 3 ALYCONE study, where combining Darzalex with three older drugs halved the risk of disease progression or death compared to those drugs alone.
With ALYCONE, Janssen secured one of the six coveted slots for late-breaking presentations at the annual meeting of the American Society for Hematology (ASH) — putting its clinical research in front of thousands of oncologists' eyes.
While most of the data was first disclosed upon release of the study abstract in November, late-breakers usually get extra attention from the medical community.
In the trial, Darzalex was combined with Velcade (bortezomib), melphalan and the steroid prednisone (collectively referred to as "VMP") for treatment of previously untreated patients who are ineligible for transplant. Adding Darzalex drove significantly more complete responses (43% vs 24% on VMP) and led to three times as many patients attaining minimal residual disease (MRD)-negative status.
Higher infection rates were seen, however, in the treatment arm versus the control arm.
Together, the results suggest that the Darzalex + VMP quartert could become a standard treatment option in the frontline setting.
"Monoclonal antibodies like [Darzalex] have already been approved for use in relapsed patients; here, we are showing that the benefits extend to newly diagnosed patients, as well," said Jesus San-Miguel, senior study author and medical director of the Clínica Universidad de Navarra in Pamplona, Spain, in a statement.
VMP is more commonly used as the standard of care in Europe, but ALYCONE is just one of several studies J&J's Janssen arm is conducting to prove the drug's utility in the frontline setting.
"As we do these combinations, our view is that you can combine Darzalex with many different mechanisms and you get dramatic improvements," said Janssen's Lebowitz.
In the past decade and a half, eight new agents for the treatment of multiple myeloma have been approved in the U.S., most of which are either proteasome inhibitors or immunomodulatry drugs like Celgene Corp.'s Revlimid (lenalidomide).
Darzalex, on the other hand, is the only anti-CD38 antibody. Lebowitz argues that this gives Janssen an edge in that Darzalex doesn't just replace an existing agent with a similar effect, but rather adds a new mechanism of action when used in combinations.
In parrallel, Janssen is also advancing the study of Darzalex in smoldering myeloma, an earlier form of the blood cancer, which could move the drug into less advanced patient populations.
Phase 2 data presented at ASH demonstrated Darzalex's safety profile in smoldering myeloma was similar to what has been observed in the relapsed or refractory setting.
Janssen licenses Darzalex from the Danish biotech Genmab A/S, which earns royalties on sales.