From the ONCY boardAround 14 mins long, this was taped right after the recent SPA approval.
A few noteworthy points:
- The US phase II H&N trial is almost finished.
- The OS data in the phase II H$N UK trial is about doubling that of the 4-6
months historic control estimate.
- Additional SPAs are expected to be filed later this year and next year on
other indications.
- A new web site will be launched around the time of the start of the phase III
trial. This site is meant to aid potential patients to find appropriate trials
they may be qualified to enroll in.
Proboscises here again. Some additional comments in the podcast are:
- The typical second line reponse rate in Head and Neck cancer patients (chemo alone in refractory patients) is 3-10%. The progression free survival in this group is typically around 2 months and the overall survival is 4-6 months.
- With the REOLYSIN/chemo combination treatment we are seeing a 40% response rate, which is 5-10 times the response rate one expects to see in this patient group. Progression free survival is at least 3 times what one expects to see in this patient group.
- And finally an incredibly telling comment about the trend of the phase 2 H&N trial (which is almost finished) with important implications for the phase 3 trial:
"We just tripped over doubling the overall survival rate for that group (the refractory head and neck cancer patients)."
The above quote is significant because:
1. With a greater than doubling of overall survival one can expect the phase 3 trial to be completed after part a. That is, the results will reach statistical significance leading to approval after just the first 80 patients.
2. Brad said, "We just TRIPPED over doubling the overall survival rate". What he means by this is that as time passes patients continue to survive so that the overall survival time is continuing to increase. At this point the overall survival is double the norm, but as more time passes we can expect that survival benefit to increase even more.