Sigmadotlarvoldotcom contains a user-operable database containing a complete listing of Cabo trials, some of which I'd never heard of...and which are listed as pending. For one, a pending 308 trial for delayed onset of bone mets...which I would truly love to see... is proposed for 9/13.
Of course, I haven't gained user access, but there are some compelling posts to be found, including a reference to a pending Subpart H filing in mCRPC....What the heck?
"For one, a pending 308 trial for delayed onset of bone mets...which I would truly love to see... is proposed for 9/13."
The 308 trial was part of the initial CRPC Cabo strategy. That strategy changed after an ODAC meeting to discuss possible endpoints based on bone met effects in Sep 2011. It was not a meeting to discuss a specific drug, but everyone realized it was a prep for an upcoming Amgen supplementary NDA for XGEVA, based on delaying the onset of bone mets by a few months. Amgen's XGEVA data was a statistically significant result that was not deemed to be clinically meaningful and ODAC and FDA gave it thumbs down. EXEL (in my opinion) took the prudent course and decided to concentrate on the refractory end of the disease and tabled the 308 trial. Any reference to it now is out of date.
I've been hinting at this for a while, but I'll drop the subtlety. I am skeptical that Cabo will have a place in pre-chemo CRPC. It will definitely have a place at the refractory end of the disease. In other indications it will be the TKI of choice at the refractory end, and it may compete well against competing TKI's in frontline settings. In RET driven disease, Cabo stands a good chance of becoming the drug of choice, and it appears to maintain efficacy for longer timeframes compared to the nonRET indications. The commercial opportunity is still considerable; refractory CRPC, RCC, HCC, bladder, maybe ovarian; and the RETS, MTC, NSCLC, and DTC are all still in play.
From a pps perspective, it won't matter much for a long time. The Comets, RCC, HCC and RET NSCLC results will be out before we know anything definitive about pre-chemo CRPC.
"I am skeptical that Cabo will have a place in pre-chemo CRPC."
Nothing at all subtle about that statement.
When you get the opportunity to gather your thoughts on the topic, I'd really like to hear you elaborate a bit. The expense of trials directed at pre-chemo has bothered me for some time, particularly when the obvious play has been toward the "low hanging fruit" of refractory settings...
Is it Cabo's toxic profile that puts you off on frontline CRPC...or something more subtle?
Chat when you can...
I found the following business description at Bloomberg BusinessWeek:
"Larvol Group, LLC provides competitive intelligence tracking services for pharmaceutical, biotechnology, and life science companies. It offers brand level, franchise level, biomarker and scientific, strategic, and ad hoc tracking services, as well as support services. The company also provides weekly dashboards, news tracking, and analytics tailored to address specific competitive and product interests in oncology and CNS therapeutic areas. Larvol Group, LLC was incorporated in 2005 and is based in San Francisco, California."
My take is this: Bruno Larvol sells subscriptions to his interactive database as a tool by which to research the competitive therapeutic landscape. Though directed primarily at pharmaceutical companies, I can easily see a variety of applications. There are even provisions within the underlying format to track patient sentiment, unpublished company strategy, and proposed FDA response to future NDA filings. Looks like a very cool tool to me...as it is based upon a high level of informed inference. I gotta admit, I still very much like the idea of a #308 study to "study the impact of Cabo on delaying bone metastasis"... Anyone that has been around the block w/ EXEL knows that the Comet trials were formerly known as trial #'s 306 & 307....so this reference makes good sense.
Sort of as if all the hypothetical "jawing" that takes place on this MB were fed into an EXCEL spreadsheet...and offered up for sale to all of EXEL's competitors.