|Genmab CEO Jan van de Winkel|
Johnson & Johnson ($JNJ) and Genmab have played another card in their deck of data on the multiple myeloma blockbuster contender daratumumab, spelling out some encouraging data that's now being used to help persuade the FDA to deliver a fast marketing approval.
Focusing on the group of patients getting the top dose, investigators reported in the New England Journal of Medicine that the drug scored a 36% overall response rate among 42 patients with late-stage multiple myeloma--a step up from the 29% overall rate that was reported at ASCO earlier in the year. And two thirds of the responder group benefited from progression-free survival after 12 months of therapy. The dose-escalating study also satisfied researchers that they would be able to use the 16 mg dose for all future studies of the drug, an IgG1k antibody that binds to CD38 on the surface of multiple myeloma cells.
Daratumumab has excited a range of analysts happy to roll out multibillion-dollar projections for this drug. Kyprolis won an approval for Onyx with a 23% ORR, and then was bought out by Amgen, which recently scored a new combo approval for relapsed cases, looking for more of an edge in its fight to steal market share from Celgene's ($CELG) Pomalyst.
Bristol-Myers Squibb ($BMY) and its partner AbbVie ($ABV), meanwhile, have followed up with a Phase III program for another 'breakthrough' multiple myeloma drug, elotuzumab, which zeroes in on signaling lymphocyte activation molecule (SLAMF7) antigen and is believed to both target multiple myeloma cells and spur an immune system attack by acting on natural killer cells.
Daratumumab was near the front of the line when the FDA started handing out breakthrough therapy designations, giving this drug an inside track at the agency and a clear shot at an accelerated approval--particularly in light of the agency's open-door policy for most new cancer therapies.
J&J signed off on a $1.1 billion package to partner with Genmab on the drug, and it's been hustling along ever since, mounting combo studies to help position the drug once it hits the market.
Genmab's shares surged 7% on the news.
"Patients who have relapsed or refractory multiple myeloma currently have very limited treatment options. The results from this first-in-human study of daratumumab, presented in full in The NEJM, show an impressive response rate and duration of response, particularly when you consider that patients in the study had received a large number of prior treatments," said Genmab CEO Jan van de Winkel in a statement.
- here's the release