VANTAGE 14 Did Not Meet Primary Endpoint: Merck


I genuinely, and earnestly thank Whitehouse Station, for being so forthright in its announcement of this, earlier this week. Rather than trying to “paint a smiley face” on it, and talk about secondary endpoints, or run a selective subset of the data to show some artifical “win“, it simply said the study. . . clanked.

And that is good, in the long run, for advancing science, and expanding the knowledge base — of what works — and what doesn’t in oncology. This is a stark contrast to the prior practice at legacy Schering-Plough (under Fred Hassan and Carrie Cox) — and a welcome one — even if it is marginally bad news for New Merck. From the presser, then:

. . . .A Phase III study of Zolinza® (vorinostat) for an investigational use in patients with advanced malignant pleural mesothelioma who previously have been treated with systemic chemotherapy containing pemetrexed did not meet its primary endpoint of demonstrating an improvement in overall survival. Full results of the trial, called VANTAGE 14 (Vorinostat Clinical Trials in Hematological and Solid Malignancies), will be presented at the 2011 annual joint Congresses of the European Multidisciplinary Cancer Congress (ECCO) and the European Society of Medical Oncology (ESMO), in Stockholm, Sweden, September 23-27, 2011.

Vorinostat (marketed as Zolinza) is an oral histone deacetylase (HDAC) inhibitor manufactured by MSD and is indicated for use in the United States for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

Mesothelioma is a type of cancer that begins in the mesothelium, a thin layer of tissue that lines several different organs and spaces inside the body. The most common form is pleural mesothelioma, in which tumors develop in the tissue that lines the chest cavity. . . .

In any event, the drug will continue to be sold in the US for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s