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Exelixis, Inc. Message Board

  • metropath metropath Jun 12, 2013 8:50 AM Flag

    another note in GS conference

    MM:We're very interested in moving cabo up in the lines of therapy. We've talked about doing abiraterone-cabo combinations pre-chemo, [enthulodomide] (it should be enzalutamide/MDV-3100)-cabo combinations pre-chemo. And those Phase 2 trials, randomized Phase 2 trials, start sometime in the second half of this year.....So we had some Phase 1 data at ACR from Dana Farber combining abi with cabo with [decent] and a small piece of population but we're ready to go with that and we're not that much positive behind with the [enthulodomide]-cabo combination.

    Does anyone has any data for phase 1 enzalutamide/cabo information? I wonder why MM mentioned: WE'RE NOT THAT MUCH POSITIVE BEHIND WITH ENTZALUTAMIDE/CABO COMBINATION. on what data?

    Sentiment: Strong Buy

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    • You always have to take the seeking alpha transcriptions with a grain of salt. Here is what was actually said;

      "MM: We're very interested in moving cabo up in the lines of therapy. We've talked about doing abiraterone-cabo combinations pre-chemo, enzalutamide cabo combinations pre-chemo. And those Phase 2 trials, randomized Phase 2 trials, will start sometime in the second half of this year. Mechanistically it makes sense, as patients become refractory to ADT, they often do so because their CTC levels go up and those CTC’s contain more MET, and MET makes those CTC cells more invasive, more metastatic. So mechanistically it makes sense, cabo decreases CTC levels, cabo can resolve existing bone lesions by bone scan, so it’s got the right clinical/biological profile I would think, to combine in terms of that early early stage effort. So we had some Phase 1 data at AACR from Dana Farber combining abi with cabo with decent and a small patient population but we're ready to go with that and we're not that much farther behind with the enzalutamide-cabo combination."

      • 3 Replies to erniewerner
      • ....as patients become refractory to ADT, they often do so because their CTC levels go up and those CTC’s contain more MET, and MET makes those CTC cells more invasive, more metastatic. So mechanistically it makes sense, cabo decreases CTC levels,..."

        This statement is pretty significant. We have known about the work identifying CTC's as a marker for poor prognosis and the reduction of CTC's as a marker for improved outcome. However this remark goes quite a bit further. It is identifying increased CTC levels as a means of ADT resistance. Markers can be merely an artifact or they may be a link in a pathway that is integral to a cause/effectIt relationship. He is also identifying the increased CTC MET expression as the likely means by which Cabo reduces CTC's and hypothecates that Cabo mediated reduction of CTC's will delay ADT resistance. Pretty interesting.

        He also identified two new randomized trials to start later this year, Cabo/abi and cabo/MDV. It's pretty interesting stuff, but results are literally years away. Of more immediate concern are MTC OS topline data, initiation of HCC and MET NSCLC trials, GDC 971 decision, full enrollment for Comets, and Comet 2 topline results.

        They are still sticking to the guidance for Comet 1 in 2014. My best guess is that this actually refers to an interim analysis. Interim analyses are typically powered to only show highly significant results, so it may be optimistic to expect 2014 unblinding for Comet 1, but we will see.

      • ernie, you are the king here!

        Sentiment: Strong Buy

      • Roger that. Good to know. The 10 months for the control arm makes the survival benefit seem more piddling but at least still likely positive. This should be sufficient for approval.

    • "I wonder why MM mentioned: WE'RE NOT THAT MUCH POSITIVE BEHIND WITH ENTZALUTAMIDE/CABO COMBINATION. on what data?"

      Possibly a transcription error?

      Jim

    • Nice catch; I wish the interviewer had delved into that a little more. Using two receptor side inhibitors could complicate things more than using a ligand inhibitor and a receptor inhibitor.

 
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