Delving Into Seattle Genetics, Inc. (SGEN)’s Upcoming Readout

The primary endpoint is judged by the proportion of patients achieving an objective response that lasts at least 4 months, within a timeframe that spans a period from first dosing to disease progression, death or study closure (the aforementioned May 2018). The goal is to beat the other two drugs in the investigation, so we are looking for a higher proportion of patients in the brentuximab arm lodging a 4 month OR than in either the Methotrexate arm or the Bexarotene arm.

There are a few secondary endpoints, including complete response rate and progression free survival (again, measured in comparison to the other two arms) and a symptom burden measure. The latter is likely the least important from an approval standpoint – these sorts of treatment don’t have great safety and tolerability profiles as they are, and the FDA will recognize that when it makes its decision. In other words, if the drug shows an improved efficacy over the other two drugs in the study, the FDA will likely accept a slightly less tolerable toxicity profile as a kicker to brentuximab’s approval. This is not set in stone, of course, but we’ve seen it happen before.

That’s the science, the trial and the data out of the way – what are we looking at from a timeframe perspective? Well, as mentioned, the company expects to put out topline from the trial during the current quarter. Assuming the trial meets its endpoint, and improves upon the OR proportion of its peers, we could see an NDA before the close of the year – maybe stretching out to end Q1 2017 if there is any hold up. It’s an sBLA, so we should see a pretty quick turnaround from the agency, and we’re looking at an approval sometime H2 2017.

Note: This article is written by Mark Collins and originally published at Market Exclusive.