Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Musings Regarding Pozi Z20 (and the 4thQ CC).
When analysts ask “What is the ORR bar (benchmark) that pozi has to get over for the Z20 trial” JT/ FL say they can’t tell us for competitive reasons. Outwardly, there might be some truth to that but thinking about it, in negotiations w the Agency on the protocol before the trial starts, you think they’re going to say to Spectrum “you’re going to have a 20% bar to jump while Takeda for exon 20 is going to have a 25% bar”? No way! The FDA has a certain expectation and it should be the same for all biotechs testing their drug in exon 20. What got me thinking about this is a look at IMGN’s Presentation. They have a slide for their trial for mirvetuximab where they list the FDAs expectation of 12% ORR so why can’t Spectrum do likewise?

Along the same lines, last year, at Guggenheim, FL mentioned they were going to look at some fully annotated databases to see what the ORR benchmark really should be for exon 20 instead of available data for unselected patients. I would love to know what they found out about historical efficacy using current SoC. Do you think these databases are not available to Takeda? Of course they are available and then some.

So I would love for Spectrum to be more forthcoming at the Quarterly meeting this coming Thursday on this topic. The analysts don’t seem to want to ruffle their features in asking them. Heck, I’m not proud, I think I’m going to shoot them an email asking them to provide some more clarification at the meeting. I don’t see why they can’t.