Phase II data from Genmab (CPH:GEN) have ratcheted up expectations for a fast-track approval of its Johnson & Johnson ($JNJ)-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.
|Genmab CEO Jan van de Winkel|
J&J subsidiary Janssen trialled the antibody--daratumumab--in 124 patients with the bone marrow cancer multiple myeloma who had already received at least three different lines of treatment, such as Celgene's ($CELG) Revlimid and Takeda's Velcade. In this hard-to-treat subpopulation, daratumumab achieved an overall response rate (ORR) of 29.2% and median duration of 7.4 months, both of which have raised hopes of an expedited filing and approval.
"We believe a sub-20% ORR in the Sirius study would probably be sufficient for approval," Jefferies analyst Peter Welford wrote in a note to investors. The optimism is underpinned by FDA's handling of Kyprolis, the multiple myeloma drug which contributed to Amgen ($AMGN) paying $10.4 billion (€9.1 billion) for Onyx Pharmaceuticals. In a trial of 266 patients who had received two lines of treatment, Kyprolis achieved an ORR of 23% and median duration of 7.8 months.
The data were strong enough for Kyprolis to win approval. And with daratumumab having snagged a FDA breakthrough designation in 2013, analysts and investors are optimistic it will soon join the arsenal of drugs available to physicians treating multiple myeloma. Genmab shares were up 9% in Denmark following the news. Current data will limit daratumumab to use as a salvage therapy, but Janssen is running a suite of trials that could expand the antibody's label and make it a blockbuster.
Late-phase trials of daratumumab as a first-line treatment in combination with other drugs--including Revlimid and Velcade--are already underway. Welford has tipped worldwide sales to top out at $3.5 billion, a figure that would allow Genmab to weather declining sales of its chronic lymphocytic leukemia drug Arzerra.
The upbeat outlook soured somewhat within hours of the data being released when GlaxoSmithKline ($GSK) revealed plans to sell its 7.9% stake in Genmab. GSK was regarded as a potential buyer of Genmab, but those rumors have cooled over the past 5 years. Now, with GSK selling its oncology portfolio to Novartis ($NVS), it views Genmab as a noncore asset. Genmab's stock opened down 5% following the news.
- read the release
- and the GSK news
Editor's Note: This article has been updated with details of GSK's plan to sell its stake in Genmab.