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Exelixis, Inc. Message Board

  • parsnipsnbeets parsnipsnbeets Apr 5, 2013 12:52 PM Flag

    Good news at 40 mg

    Results Among 11 evaluable subjects enrolled at 40mg, there were 9 partial responses (PRs), 1 complete Update 4/3/13:
    response, and 1 stable disease (SD). Of 10 subjects subsequently enrolled at 20mg, there were 1 PR, 5 SDs, and 4 with progressive disease. Among 13 subjects enrolled on the 40mg expansion cohort, there were 6 PRs and 7 SDs. No subjects required dose reduction or treatment interruption at 6 or 12 weeks; 3 subjects at dose level 0 discontinued due to AEs by 12 weeks. At 40mg, median treatment duration was 27 weeks. 58% of subjects with ≥5 CTCs/7.5mL at baseline converted to

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    • What stands out in this 36 patient trial is the use of bone scan response as the primary endpoint.

      Cohort 1 =12 patients on dose 40mg
      Cohort 2 =11 patients on 20mg
      Expansion Cohort =13 patients at 40mg

      By 12 weeks 16 PR and 3 CR in 19 of 25 subjects on 40mg = 76% Bone Scan Response.

      This compares favorably with the 68% BSR seen in the earlier Cabo 100mg dose trial.

      Sunitinib showed a weak response in 6 of 25 subjects in mCRPC for a BSR = 24%

    • $$$$
      Good find. The importance of peer-reviewed publication may prove inestimable, and the timing is certainly aligned with the start-up of the AACR. Any clinical trial work-ups involving co-authoring by Mass Gen's Matt Smith and Dan Haber are worthy of review. Haber's pet research project w/ Mass Gen funding is a hyper-efficient CTC enumeration platform that may eventually be proven to outperform the Veridex Cellsearch.

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