Did I understand correctly that the trial will be a head to head comparison with IF Na with the agreed upon endpoint being PFS? My understanding, and I'm not at all sure I heard this correctly is the comparator, which is approved for usage now had a PFS of 5 months and Cabo in Phase demonstrated a PFS at this 60mg dose of 14.7 months. Did I get this correct? Are they then avoiding a head to head comparison with Sutent in order to get a relatively easy approval in get in the cue of drugs to be eventually used by almost all of these RCC patients?
I wish I knew how scroll back up in this new Yahoo format so I could proof read my typing. My last post was an English as a second language special.
RCC is 2nd line Cabo vs Everolimus with a PFS endpoint. No crossover and patients are followed for secondary OS. HCC is 2nd line vs placebo with an OS primary endpoint. In addition there is a CRADA trial being done in 1st line RCC vs Sunitinib, but it is only planned for 140 patients, so the powering is modest.
They are playing things very safe, as a result, these are not huge opportunities, but there is a very good probability of success. 2014 will be a very busy year for EXEL.
Thanks. It seems that they are building a solid base with2nd and 3rd line use which should keep them afloat and make them quite profitable in combination with the prostate approval ( I hope and assume). There's a lot of competition just behind them in trials I think for these same slots. Is it your view that Cabo has legs and that Exel will have time to do follow up trials in the 2015 plus period for first line apllications?