Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Evolution of Rolontis clinical trial requirements for BLA. Followed Rolontis trial requirements via their Presentations starting w Analyst Day back in March 2015

Two 500 Patient trials, one in North America & one International Study

May 2015 Presentation

? Phase 3: (2) Well Controlled Studies
o 1st: Breast Cancer
o 2nd: Awaiting Regulatory feedback
o Phase 3 Endpoint: Duration of Severe Neutropenia
? Currently Finalizing Phase 3 Protocol

Sept 2015 Presentation

SPI-2012: Phase 3 RegistrationalStudy
?Met with FDA and EMA
?Primary endpoint will be duration of severe neutropenia (DSN)
?Over 90% to demonstrate non-inferiority
?Powered at 80% to demonstrate superiority to pegfilgrastim
?Pursuing Special Protocol Assessment (SPA) for Phase 3 study

Nov 2015 Presentation

Primary endpoint will be duration of severe neutropenia (DSN)
?Phase 3 study will be in breast cancer patients
?Pursuing Special Protocol Assessment (SPA) for Phase 3 study
?The proposed study is a non-inferiority study

Feb 2016 Presentation

?Phase 3 study is conducted under SPA with FDA
?Primary endpoint is duration of severe neutropenia (DSN)
?Phase 3 study is in breast cancer patients
?The proposed study is a non-inferiority study

Ran out of time to really comment at this time. Hopefully, will look at this more closely along with any relevant CCs that might discuss the trial this weekend or next week. Qs that pop up include - do they really only need 1 pivotal (BLA) study in the US to submit application or were they not getting timely feedback from the EMA so they just focused on the US trial? and - Is it still powered at 80% to demonstrate superiority to pegfilgrastim. OK, back to enjoying the weekend.