CHICAGO--It was Johnson & Johnson's ($JNJ) turn to take center stage at ASCO Saturday morning, fleshing out the promising data that it accumulated in a Phase II study of daratumumab for treatment-resistant multiple myeloma.
The 106 patients recruited for the Phase II study were very sick, looking for a last-ditch treatment after failing at least three other therapies for the disease. The drug was credited with an average 3.7-month delay in disease progression with 65% still alive after the first year.
The late-breaker at ASCO helps build a case for a quick approval of the anti-CD38 antibody, which targets a protein that clusters on the surface of myeloma cells. After a 9.4 month follow-up period, investigators reported that 29.2% of patients responded to daratumumab, with three experiencing complete remission. Responses were also durable, lasting 7.4 months on average.
Analysts have been comparing that very favorably with Kyprolis, which won an approval for Onyx--later acquired by Amgen ($AMGN)--with a 23% ORR and median duration of 7.8 months. Cancer specialists in particular are eager to get as many therapies as they can for multiple myeloma, like other types of cancer, giving J&J a clear shot for an early approval of a drug that was one of the first to gain the FDA's breakthrough therapy designation back in 2013.
J&J, which paid $135 million in cash as part of a $1.1 billion deal to partner with Genmab on this drug, is now pursuing late-stage combination studies in a bid to position this therapy as a front-line treatment, a strategy that has earned some blockbuster peak sales projections from some analysts.
|Dr. Saad Zafar Usmani|
But there are some factors that cloud J&J's prospects in the field. Multiple myeloma has been attracting considerable interest from developers. In the late-stage study of Bristol-Myers Squibb's ($BMY) elotuzumab, the myeloma drug combined with Revlimid and dexamethasone, spurred an improvement in progression free survival of 4.5 months--19.4 months in the drug arm compared to 14.9 months for the standard therapy approach. Leerink qualified that as a solid, if unspectacular, outcome.
But J&J believes it can compete in this market.
"The efficacy we're seeing is quite impressive for a clinical trial of refractory multiple myeloma, given that many patients had already undergone five or more types of treatment," said lead study author Dr. Saad Zafar Usmani, a hematologist at Levine Cancer Institute/Carolinas Healthcare System in Charlotte, NC.
- here's the release