Replies to post #129497 on Biotech Values

[NP1986]

[ONXX]

This isn't particularly good news for either AEZS/KERX and REGN/SNY. Curious what the actual results are.

I'm interested in knowing what the enrolled patient population looks like. The inclusion criteria on clinicaltrials.gov seem quite broad, so I'm curious to know just how "heavily pre-treated" the patients were. The inclusion criteria seem to allow for patients who have failed only one standard regimen, and so if second line patients were able to enroll in the study, I don't think showing a benefit against placebo is particularly impressive.

I don't think this is bad news for REGN/SNY, as aflibercept's trial was in the second line setting. Even if the regorafenib trial included second line patients, I reckon regorafenib would probably have to show activity in combination with or versus a standard chemotherapeutic regimen (e.g. FOLFOX, FOLFIRI, CAPOX, etc) in order to be used in this setting. As to whether this is bad news for AEZS/KERX, I think it primarily depends on whether the majority of patients included in the trial were heavily pre-treated.

[genisi]

Bayer/ONYX regorafenib in mCRC

Curious what the actual results are

Data are out:

http://www.prnewswire.com/news-releases/phase-iii-data-show-bayers-investigational-compound-regorafenib-bay-73-4506-met-primary-endpoint-showing-statistically-significant-improvement-in-overall-survival-in-patients-with-metastatic-colorectal-cancer-refractory-to-sta-137524158.html

Stat-sig of course on both OS and PFS (expected as the trial was stopped for efficacy) but differences are quite small (which is also something to expect in this setting) - 1.6 and 0.2 months respectively and the price to pay - a big increase in AE.