Replies to post #115355 on Biotech Values

[AlpineBV_Miller]

It is important to note that traditionally, bone metastases are not included in response evaluation for solid tumors, as standard response criteria apply only to tumors in other organs (soft tissue disease). Based on those criteria, cabo led to a modest response rate of 6%, with the majority of patients (82%) achieving stable disease as their best response.

This isn't 100% accurate. New bone lesions count as progression under RECIST. Resolution of existing lesions do not count as response under RECIST.

[DewDiligence]

(EXEL)—Amgen recently announced positive data in this setting with Dmab, which demonstrated a 4 month improvement in bone-MFS over placebo. This did not result in an overall survival benefit, further demonstrating that Dmab is not an anti-cancer drug.

I disagree with the implication that Denosumab cannot extend survival and with the assertion that Denosumab is not an “anti-cancer” drug. (I debated the latter point with jq1234 in a prior thread on this board.)

Denosumab might well have shown a survival benefit if patients in the bone-mets-prevention study had remained on drug after bone-met progression. However, when the trial in question was conducted, Denosumab was not yet approved for patients who already had bone mets, and hence the protocol called for patients to be taken off drug upon progression.

p.s. Denosumab was approved for patients with bone mets in Nov 2010 (#msg-56882220).