Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Hi muchogusto,

I can't see this being anything but a done deal in relapsed egfr patients but under the axiom of 'nothing is certain in life' let's dial it back to 'a very high chance like 90%'. Let's not forget these patients are "up the 'crick' without a paddle". From the WL PR

• This phase II study demonstrates high anti-tumor activity for poziotinib in metastatic, heavily pretreated EGFR exon 20 mutant NSCLC, a group for which no targeted agents have proven effective to date (other than patients bearing T790M or S768I mutations) with best response of PR in 55% (my note = 22/40) of evaluable patients (43% confirmed ORR to date% (my note = 17/40); 19 patients remain on treatment).
o Median PFS 5.5m; durable responses observed with 6 treated for >1year thus far.
o Compares favorably to historical ORR rates of <8% approved TKIs and <19% for standard of care 2L agents (docetaxel, PD-1/PD-L1 inhibitors).

From post 2347, the criteria for BTD is

Criteria
A drug that treats:
• Serious condition, AND
• Preliminary clinical evidence indicates that the
drug may demonstrate substantial improvement
over available therapy on one or more clinically
significant endpoints

Ah heck, make that a 100% sure it receives BTD.