Replies to post #2481 on Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Nicely said TTB.

Yes, we are scratching our heads why the agency didn't think an ORR of 43% wasn't substantially better than a combo ORR of 23%. My thoughts go to Dr Heymach at WL 2017 being asked by Adnam Butt (sp) "What is clinically meaningful" he stated

When we designed the trial 20 to 30% RRs were the rates we considered to be exciting...So RRs of 30% is extremely promising. PFS; we're looking for 4m as intriguing, 6-7m everyone would be quite excited.

and what reverberates through my mind is another Q by Adnam Butt at WL 2018 asking about ITT vs "evaluable" and Dr H responding

This wasn't designed as a regulatory study. The Q we're asking is 'is this drug active here so when you look at the population that you can evaluate the activity, this is what you see'

This somewhat dovetails w missing data on patients (i.e. LTFU). Somewhat suggestive but no way conclusive.

Anyhows, we can look forward to data this year and we know for a fact from Dr Hs comment at WL 2018 that if they did 1m scans they would have had a ORR of 55%. And we can see from simply looking at slide 7 of the Spectrum Presentation that the DOR would be longer by about a month. Those are facts in my book even though not in concrete terms.