predictions

I expect the Final Analysis to take place quite soon after the Interim Analysis.

The final analysis is triggered when no patients survive; or 18 months since the last patient started.

Recruitment was stopped on 14 April 2009. I think that one of the two patients still being treated at 1 June 2009 - the cut-off date for Interim data - was from the UK and had started in December 2008; but I suspect the second one started later, in April 2009.

When recruitment was stopped on 14 April 2009, the company said that 141 patients had been randomized. They soon changed this figure to 142, which makes me think that there was a late entry into the trial. 18 months from April 2009 gives October 2010 for the Final Analysis trigger, at the latest.

The Interim Analysis will include survival data for 95 patients. Amazingly, it appears that the original CRO created a Case Report Form which only included follow-up for 12 months after disease progression, but I am advised that all patients are followed for the actual date of death which is then included as an addendum to the CRF.

Historically, Ovature-type patients pass away about 20 weeks after DP and I expect this trend to continue in the control arm.

The Phase II PXD combination trial implied median PFS of ~ 32 weeks and Median OS of ~ 60 weeks, i.e. DP + 28 weeks. The PXD-arm median might be boosted if some patients are sensitized to salvage therapy, such as docetaxel.

My predictions are:

1. Interim analysis April/May 2010.
2. Final analysis October/November 2010
3. Median PFS for entire trial ~ 16 weeks.
4. Best PFS ~ 38 weeks.
5. Control arm median PFS ~ 12 weeks
6. Control arm median survival ~ 32 weeks
7. PXD arm median PFS ~ 18 weeks.
8. PXD arm median survival ~ 48 weeks

These results assume a 50% improvement over the control arm and would achieve P=.05 or thereabouts.

A 50% improvement would surely lead to a license deal and might even interest the FDA.