Spectrum Pharmaceutecals Inc (SPPI)

[AVII77]

back in October, on that other iHUB message board, you commented that you had to check out what was going on in another stock that was up 40% that day.

Yes, well, here I am the proverbial blind squirrel who found a nut.
The same can be said for SPPI.
Very lucky.

I was reading through the Rociletinib ADCOM minutes to get an idea of what they (the FDA) are looking for in terms of Breathrough Status. Roci won BT Status based on preliminary results. Later trial results were not so promising.

Two worthwhile reads:
Adcom minutes:
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM507560.pdf

NEJM commentary:
http://www.nejm.org/doi/full/10.1056/NEJMc1602688#t=article

In the Adcom we learn:"Rociletinib received breakthrough therapy designation in May 2014 on the basis of an overall response rate of 54.5 percent in 33 patients who received rociletinib across several doses."

The NEJM commentary notes:
On behalf of the academic authors of the Journal article published on April 30, 2015, we update our initially reported response rate of 59% to a mature confirmed response rate of 45% among patients with T790M-disease who had enrolled early in TIGER-X. This reduction in activity is less dramatic than that suggested in the Clovis Oncology press release,2 hence future analyses of the larger data set will be critical. The desire to bring helpful therapies to patients with terminal disease quickly creates considerable pressure to disseminate promising results early. However, this case offers a clear lesson regarding the importance of continued follow-up and supports a strong recommendation to publish rates of confirmed response according to RECIST, thus providing the most rigorous and mature data. Ultimately, additional data are needed to clarify the role of rociletinib in treating patients with EGFR mutation–positive lung cancer."

The Pozi data we have is very promising. But responses need to be confirmed at a subsequent scan (<cough> progressions do NOT require confirmation, and that was/is a debate from the other board).

It's also worth noting Clovis bagged this once promising drug after the Adcom.

I am struck by the difference in doses. Other EGFR drugs seem to use a much higher dose than the 16mg for Pozi. Like an order of magnitude higher. I wonder if we would expect to see fewer adverse side effects with this lower dose (or if it is not related to dosing, I dunno. Seems like Pozi patients still get the rash issue). Prolonged QTc was a concern for Roci. I recall an analyst asking about this during the Pozi webcast but I don't remember the answer.

But the story of MD Andersen's screening of this drug and prediction that it would have efficacy in this patient population is compelling. We, and SPPI, got lucky that these outside researchers not only took the initiative to do the drug-screening work but also that Pozi came out on top.