Replies to post #135274 on Biotech Values

[pcrutch]

Yeah this isn't really going to do that well. I kind of view REGN's Phase 3 VELOUR trial results the same way; stat significant p-values, but clinically relevant? Maybe not.

[NP1986]

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.

It is clinically relevant if you consider that it improves overall survival in patients with no other treatment options. I'd be interested to see the results in the KRAS mutant subgroup, as I think there is an unmet need there.

The numerical improvement in mOS is the same that Erbitux showed vs best supportive care as 3rd line therapy. It's not much, but considering the prognosis of these patients, I think it's a good option to have.

[dav1234]

Phase III Data Show Bayer's Investigational Compound Regorafenib (BAY 73-4506) Met Primary Endpoint Showing Statistically
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Posted January 18, 2012

Phase III Data Show Bayer's Investigational Compound Regorafenib (BAY 73-4506) Met Primary Endpoint Showing Statistically Significant Improvement in Overall Survival in Patients with Metastatic Colorectal Cancer Refractory to Standard Approved Therapies

Pivotal trial data to be presented for the first time at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI)



Read more: Phase III Data Show Bayer's Investigational Compound Regorafenib (BAY 73-4506) Met Primary Endpoint Showing Statistically - FierceBiotech http://www.fiercebiotech.com/press-releases/phase-iii-data-show-bayers-investigational-compound-regorafenib-bay-73-4506#ixzz1jsOZoc1W
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