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Exelixis, Inc. Message Board

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  • erniewerner erniewerner Feb 7, 2013 1:32 AM Flag

    Sunitinib-Induced Hemoglobin Changes Are Related to the Dosing Schedule

    You have to read the abstract carefully. There was one cohort of 12 patients reported on for both the 6 and 12 week observation. If you take the best response, there were 10/12 BSR's, 3 of which were CR's. But you should also roll in the 40mg results that DeBono reported in September at ESMO on a sample size of 51 with a 49% BSR (25/51). So if you pool the 40mg data we have 35/63 for a 56% BSR.

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    • "There was one cohort of 12 patients reported on for both the 6 and 12 week observation. "

      The abstract I'm looking at clearly shows original 11 patient evaluable bone scan on 1st 40 mg cohort and 13 evaluable on extension cohort on 40 mg dose on UMass abstract. Unless of course the abstract has a typo. Numbers vary depending on whether 6 or 12 week bone scan criteria is used. The 60 mg UMass was never reported to my knowledge. You may think I'm confusing the other cohort for 20 mg, but that is not the case. Actually 3 cohorts in total. 1-20mg and 2-40 mg.

      Regardless, I am glad you posted the NRE extension cohort, this certainly demonstrates the COMET populations more closely. I prefer to use the NRE cohort for my expectations. You wouldn't happen to know if there is public data out there on 60 mg would you?

      • 1 Reply to hbomb57108
      • "You wouldn't happen to know if there is public data out there on 60 mg would you?" No there isn't. The RDT NRE first stayed with the 100mg dose and then enrolled the 51 pt cohort at 40mg. The Matt Smith dose ranging study never got up to the 60mg dose because the efficacy at 40 was so high. The reslts of the DeBono 51 pt cohort seem to show that Smith's 40 mg efficacy was a bit of an outlier. Even though there is not much data on patients initiated at 60mg, EXEL does have data on fairly large numbers of patients who started at 100mg and were likely reduced to 60mg and perhaps 40mg. DeBono discussed the dosing issue at ESMO and concluded with "Nevertheless, this drug’s best dose is higher than 10 to 20 mg where it is less active, and lower than 100 mg where it is too toxic and ranges between 40 and 60 mg overall,” de Bono said during the discussion period following his presentation."

        It is not all that important, but here is how the 4566 abstract reads:

        "Results: The study completed planned enrollment of 36 pts. Median age was 66; 44% were docetaxel-pretreated. Among 12 pts enrolled at dose level 0, there were 10 BSRs at wk 6 including 1 complete response (CR), and 1 pt with stable disease (SD). The median decrease in BSLA was 62%. Ten pts evaluated at wk 12 included 9 BSRs (3 CRs), and 1 sustained SD. Among 11 pts then treated at dose level -1, 10 pts were evaluable at wk 6: 1 BSR, 5 SD, and 4 had progressive disease. No pts in the 2 cohorts required dose reduction or treatment interruption at 12 wks; 1 pt discontinued due to grade 3 AEs (anorexia, fatigue). 6/12 pts with ≥6 months follow-up remain on study. 5/5 pts enrolled at 40mg with CTCs ≥5 per 7.5mL converted to

 
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