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Exelixis, Inc. Message Board

  • erniewerner erniewerner Sep 26, 2013 9:02 AM Flag

    Comparative HR's Post Docetaxel

    Jevtana (cabazitaxel) (mito control arm) HR= .70
    Xofigo (Alpharadin) (68% prior Docetaxel) (placebo control) HR=.695
    Zytiga (Abiraterone) HR=.74
    Xtandi (Enzalutamide MDV 3100) HR=.63

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    • (68% prior Docetaxel)

      I am assuming this number is both pre and post Xofigo? The numbers I have seen for Xofigo pretreated Docetaxel are 57%. Sorry to nitpick but just curious to where you got the 68% number?

      "Of 921 randomized patients, 395 (43%) had no prior treatment with docetaxel (Ra-223, n = 262; placebo, n = 133) and 526 (57%) received prior docetaxel (Ra-223, n = 352; placebo, n = 174). Median ages were 74 years in the group with no prior docetaxel treatment and 69 years in the group with prior docetaxel.
      Median overall survival in patients with no prior docetaxel was 16.1 months in the Ra-223 group vs 11.5 months in the placebo group (HR = 0.745; 95% CI, 0.562–0.987; P = .039). In patients with prior docetaxel, median overall survival was 14.4 months in the Ra-223 group vs 11.3 months in the placebo group (HR = 0.710; 95% CI, 0.565–0.891; P = .003). "

      "Eighty-five percent of patients had 6 or more bone scan lesions and of those 40% had 20 lesions or a superscan. Opiate pain medications were used for cancer-related pain in 54% of patients, non-opiate pain medications in 44% of patients and no pain medications in 2% of patients. Patients were stratified by baseline ALP, bisphosphonate use, and prior docetaxel exposure."

    • I take it that this is all for survival in PC.

      Using patients who have a response to Cabo versus those who didn't with a univariate analysis not adjusting for co-variates:

      Bone scan response: 0.62
      CTC conversion: 0.40
      Pain: 0.65

      This is going to be exaggerated since it's very possible that Cabo is hurting the patients who didn't have a response and is clearly not the same as a control arm vs an experimental arm; however,it's unlikely the prednisone arm is going to have much of a response. This suggests that there should be some benefit...

    • And how does that relate to COMETRIQ? Is the COMETRIQ value better,worse,or equal? What do you expect if it's unknown? What value for COMETRIQ would be a winner? What value would not be good? Thanks, Ernie.

      • 1 Reply to clemcaldwell
      • "And how does that relate to COMETRIQ? Is the COMETRIQ value better,worse,or equal?"

        We do not yet know what the level of efficacy for Cabo is. We will find out when the topline results are released.

        "What value for COMETRIQ would be a winner?

        Any level that reaches statistical significance. The statistical test performed at the interim will be much more rigorous than that done at the final analysis. This is just a guess, but to pass the interim, an HR less than .65 would be required. At the final analysis, an HR of .85 more or less will suffice. Cabo will not compete with Zytiga or Xtandi, those drugs would be given earlier in the treatment cycle. Xofigo is only available from approved centers and the label precludes any soft tissue disease. Jevtana is second line chemotherapy administered by infusion. Patients experience with docetaxel may affect their willingness to undergo this therapy.

        Cabo has advantages. It is a simple pill. It may earn a pain label which none of the other drugs I mentioned possesses. Although it will probably not be mentioned in the label, it is known to have a profound effect on bone disease as measured by bone scan. As long as the drug is approved, there will be a market for it even if the HR does not match the competing alternatives.

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