My take on the Jeffries 2017 Global Healthcare Conference is I didn’t think I would find out anything new since we recently had the Deutsche Bank HCC, the quarterly update, and the BoA HCC CCs but it turns out there were a couple of things that were new. Let me start by saying Joe Turgeon presented. The 1st minute or so, I said oh, oh, he sounds kind of shaky and tentative but after he got rid of the initial jitters he was pretty good. I prefer him to Raj. With Raj you always wonder how much he is exaggerating.
- From the BoA HCC, we learned that they were convening a lung cancer advisory board (on May 19th I think) to decide whether to expand the Poziotinib P2 trial to other centers. Well, we learned today that Spectrum will be starting a multi-center trial in parallel to the current one at MD Anderson in exon 20 insertion mutations in the coming months. Hopefully, it will be a pivotal one.
- The compassionate use patient with the NSCLC exon 20 insertion mutation still has stable disease after 7 months whereas less than 2 months PFS is the norm.
- Reiterated that they will be doing a combo breast cancer trial w Poziotinib in the 2nd half. Note at the quarterly they mentioned early stage so today JT mentioned it’s in 2nd line as opposed to the current study in 3rd line therapy. What was interesting, and I’m not sure if it was inadvertent or not, was there was no mention of it being in combo with T-DM1 which they mentioned in earlier CCs. Right now, I’m assuming it was inadvertent.
- JT indicated that the smaller 2nd international P3 trial of Rolontis was needed for US NDA approval. This makes sense to me since you usually need 2 successful trials to get approval. If you heard Raj in recent CCs (Q1 CC comes to mind) he was indicating that the US P3 was all that was needed since it had a SPA. He apparently was incorrect; not the 1st time and probably not the last. We also learned that the 2nd P3 has started dosing patients. Some other stuff on this but I’ll leave it there.
- I’ve posted multiple times that I always thought that apaziquone is a good drug and as the saying goes “the trial failed, not the drug” and that it would have been a much-needed tool in the shed and if the FDA didn’t approve it well then that’s their choice and that’s that. But Spectrum has been saying they will start another trial with 70% less patients and they got a SPA after discussions with the FDA. While JT said ‘beg’ was too strong a word, the FDA did ask them to continue with another study. JT said the study will start next month in all likelihood.
-Lastly, Spectrum is continuing to pooh pooh their drug revenues, and that these revenues are just a means to fund their biotech discovery so think of them as clinical stage biotech company with several late stage products getting close to the finish line. He even shortchanged how much revenue was coming in saying “a 100 million, a 100 million plus” in revenues. Well, I guess you should think of them as a clinical stage biotech company, and one where current revenue is not important compared to what’s in development. Now they got to convince the street, I guess that’s why we’ve had all these CCs recently.
