Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Hypothesis on why MDA is treating 1st-line EGFR exon 20 mutation patients and not the HER2 mutation. It could have been an oversight when they revised the protocol in July but now that they updated the protocol again and still did not put verbiage that they will treat 1st-line HER2 mutation patients tells me that it was not an oversight. I'm thinking that with the EGFR mutation, they accumulated enough data to go to the FDA and say, "Hey, this is pretty effective in EGFR metastatic disease and we believe it will be effective in treating 1st-line pts" and the FDA said "Hey, makes sense. You got our blessing" whereas with the HER2 mutation, they started treating patients ~ 4 months later (July vs March), and less quickly too, so they are still accumulating HER2 data to go to the FDA to get pts treated in 1st-line HER2. IMHO.

Edit - On INSPIRE, I remember reading about the wife of one pt (I believe paula123) saying that MDA is now looking to treat pts who weren't treated before which I dissed away thinking she didn't get her facts strait but it all makes sense now.

Edit 2 - Hand and hand with the slower recruiting is perhaps having a bonafide test for HER2. It seems they have some good tests for EGFR. Here is what it says in the protocol

Previously untreated patients are eligible only if EGFR Exon 20 mutation is confirmed using an FDA approved device: cobas® EGFR Mutation Test v2 or therascreen® EGFR RGQ PCR Kit prior to study enrollment.