Replies to post #2316 on Spectrum Pharmaceutecals Inc (SPPI)

[Doji Dragonfly]

hehe antihama nice read and all help is appreciated. Would like to see share price at least at $20 dollars again this low is ridiculous.

[antihama]

Just read Hero's reference on RA using ORR on the Yahoo board. So apropos! In my post, I was wondering if SPPI, from their pozi P2 study using ORR, would be able to get RA or would they get AA.

And while he [JT] said it in the past, it would be nice to get confirmation that the SPPIs cohort can result in regulatory approval and is that AA or full approval (I'm thinking FA since their is no SoC to compare it to in a P3 study)? - antihama

And this is what the reference is saying

Abstract
IMPORTANCE:
Objective response rate (ORR) is an increasingly important end point for accelerated development of highly active anticancer therapies, yet its relationship to regulatory approval is not well characterized.

OBJECTIVE:
To identify circumstances in which a high ORR is associated with regulatory approval, and therefore might be an appropriate end point for definitive single-arm studies of anticancer therapies.
RESULTS:
From 1800 trials, 874 eligible trial arms in 578 eligible trials were identified; 542 arms had ORR data available for 294 regimens. Maximum ORR and mean ORR were significantly associated with regulatory approval (t?=?0.27, P?<?.001; t?=?0.12, P?=?.01); this relationship was stronger for single-agent therapies (t?=?0.49; t?=?0.41) than for combination regimens (t = 0.28; t = 0.17). Evaluation of ORR thresholds between 20% and 60% as potential trial end points demonstrated that ORR statistically exceeding 30% with a single agent had 98% specificity and 89% positive predictive value for identifying regimens achieving regulatory approval.

CONCLUSIONS AND RELEVANCE:
For single-agent regimens, high ORR was associated with regulatory approval; this relationship was less strong for combination regimens. Our data suggest that high ORR (eg, statistically exceeding an ORR of 30%) is an appropriate end point for single-arm trials aiming to demonstrate breakthrough activity of a single-agent anticancer therapy.

Answers my question. Note I misstated in my quote- regulatory approval = full approval

https://www.ncbi.nlm.nih.gov/pubmed/26914340

[antihama]

And more detail on recruitment in the SPPI study would be fantastic. Telling us recruitment is going well doesn't say anything. It would be nice if he stated when that might happen e.g. "Recruitment is strong and based on current trends we expect the egfr cohort to be fully recruited by approximately the end of the year give or take a month" or something like that would do wonders. Give as much clarity as possible. - antihama

Thinking about this further, recruitment might take longer than I thought if we need to wait for the EU part of the trial, since as of now, we haven't heard anything regarding whether the EU part of the trial started recruiting. But the optimist in me says maybe not because after the EU contingent, Japan would be recruiting next, and do we have to wait for the Japanese contingent too? JT (or anybody), can you explain it a little further please. Maybe BTD can start the ball rolling on the US contingent.