Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

I would say mission accomplished! Way back on St Patty's Day they started this trial expecting to recruit 30 patients - all EGFR mutations, it was then doubled to 60 pts to include the HER2 mutation before adding another 10 to each cohort for a total of 80 pts and now they stopped recruiting at 55 pts. As an educated guess, I would assume they have almost all the EGFR exon 20 insertion mutation pts and around 15 HER2 exon 20 insertion mutations pts. Early on they indicated they needed data from around 10 pts from each cohort to go to the FDA to petition for breakthrough therapy designation. And considering at the London Jefferies conference they indicated they were meeting with the FDA to have a preliminary discussion on breakthrough therapy designation in sometime November, I would think that things went well with those discussions and it wasn't necessary for the MD Anderson trial to recruit more patients. New patients won't be left in a lurch since there is the new bigger Spectrum trial which pts can join which has 4 trial sites listed so far.