Hey kids, remember that “HOCKEY STICK" enrollment? Well...
cj reminds us this morning that Peregrine now has 152 clinical sites open for the Double Blind phase3 SUNRISE trial.
The phase2 was powered to 40 patients per arm.
SUNRISE has been open for a year this December. If just 150 sites have each treated one patient in a year, we are at (150) 75 patients per arm now treated. That is nearly double the number of patients treated per arm in the phase2 trial.
CP has been estimating patients treated to be one patient every two months. Using 150 sites treating one patient in two months, we would, maximally, have 6 patients from each site in a year. Times: 150 sites = 900 patients...for a 582 patient trial.
Well we know that all clinical sites weren't open December 2013. We do know that about half of the sites were open in June 2014, and all the sites are open now, a year into the trial. Site openings averaged 12 per month over the year.
Are we approaching (450) patients treated: 225 per arm now?
Are we approaching (300) patients treated: 150 per arm now?
Either case should power an early look-in that could change the game for BAVI, anti-PS.
We have seen projective graphs of the patient enrollment here on the PPHM IHUB. They are constructed using announced trial site openings throughout the year with estimated patient treatments per site. It will be interesting to see this next graphing of SUNRISE.
Peregrine has two early look-ins that will be triggered by unspecified numbers of “events” and use unspecified surrogates.
Peregrine wants to see certain data that can be used as surrogate endpoint(s). These data could, conceivably, break open the trial and precipitate an FDA Accelerated Approval, AA, for BAVI in lung cancer.
If BAVI is performing as well as it did in the phase2 trial, early FDA approval is highly probable. IMO.
Always, IMO
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