Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Comments on the Cantor Fitzgerald Global HCC from Oct 2nd. Got to listen to it quickly prior to vacation and I knew I wanted to listen to it again when I got back and just did.

On previous postings, I was wondering whether the MDA basket trial was going to be multi-site and international. Well, we heard that SPPI will be running their own basket trial so following the NSCLC script, SPPIs trial will be multi-site and international (I assume). JT said SPPI will hopefully start their trial later this year but if they did that I can't see MDA getting enough pts for theirs and certainly won't have enough pts/data to use for BTD for pan tumor. So, either MDA doesn't do their own trial and SPPI starts their trial later this year w MDA becoming one of SPPIs sites or SPPI will start their trial next year (note - there was about a 6m spread between the start of MDAs and SPPIs NSCLC trials). We'll see.

In my previous post I stated regarding what I was hoping to hear at the CC

Quote:
And more detail on recruitment in the SPPI study would be fantastic. Telling us recruitment is going well doesn't say anything. It would be nice if he stated when that might happen e.g. "Recruitment is strong and based on current trends we expect the egfr cohort to be fully recruited by approximately the end of the year give or take a month" or something like that would do wonders. Give as much clarity as possible. - antihama

Thinking about this further, recruitment might take longer than I thought if we need to wait for the EU part of the trial, since as of now, we haven't heard anything regarding whether the EU part of the trial started recruiting. But the optimist in me says maybe not because after the EU contingent, Japan would be recruiting next, and do we have to wait for the Japanese contingent too? JT (or anybody), can you explain it a little further please. Maybe BTD can start the ball rolling on the US contingent.

Well, JT said they'll give guidance after the 1st of the year. So, the primary endpoint of the study is ORR at 2 yrs and they still haven't started recruiting their EU pts. If they finish recruiting by July 2019 w EU pts (somewhat of a best case scenario), add 2 yrs to get your primary endpoint, and another 3 months to put the submission together, and another 6 months for FDA approval, that takes us to the 1st half of 2022. The data may be mature enough before the last pt goes 2 yrs after dosing but I was so hoping for some regulatory clarity. Do we have to wait for the EU contingent? What about the Japanese pts he talked about previously? Is there some type of Adaptive Design that will accelerate time to approval? I'm not concerned with US pts getting recruited but as of now, without any guidance, you have to assume approval won't come till the middle of 2022 if we’re waiting for EU pts.

On a similar vein, JT says he's 'quite pleased' w enrollment. Maybe so in the US but they haven't started recruiting in the EU yet. How can you be 'quite pleased' w that?

Lastly, there was a Q&A on ‘best case’ approval for pozi using MDA data (could they use some of the data from SPPIs trial?). I assume they’re talking AA but would the FDA be comfortable in looking at ‘evaluable’ pts instead of ITT? Actually, I could see that happening but it would have to be after SPPIs trial is fully recruited, otherwise they would have trouble recruiting pts when the drug is already on the market (as Dcaf used to say about Qapzola getting AA while they tried to recruit for P3).

So I was left feeling that until Spectrum gives us some more Regulatory clarity regarding what impact the EU pts recruitment will have on the study and whether they need to wait the full 2 yrs for the primary endpoint we have to assume approval will be later rather than earlier. I guess that was my biggest takeaway from the CC, probably the Street too. The quarterly meeting is coming up in Nov, hopefully they'll explain the regulatory process further then or perhaps at another healthcare conference before that.