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Vical Incorporated Message Board

  • viclobserver viclobserver Jul 5, 2013 3:50 PM Flag

    PART #1 POTENTIAL Yervoy effect upon the phase 3 Allovectin-7 study control arm.

    1) 62% stage 4 in the A-7 Phase 3 .... by the time they progress they have little time to get into a new study.

    2) ONLY appx. 40% of the A-7 study in the US.

    3) So, let us assume that all of the US control group was able to access Yervoy, even though that is more than double the best case scenario. Because Yervoy was NOT approved until March 2011, and the last US patient was enrolled in Feb. 2010, which is 13 months. Since the mOS is 12 months, most of the control would have been dead by then. Therefore, if there was any significant usage of Yervoy, it was from the Compassionate use programs, which were only in the US until close to approval, and only in Italy.

    4) In the Yervoy study that combined with chemo, the mOS survival advantage was 22.2% Chemo damages the immune system, and that is why the survival advantage dropped, even though the dosage was increased from the FDA approved dosage of 3mg/kg to 10mg/kg.

    5) If the expected mOS is 12 months, then let's use a 25% increase to account for the potential use of Yervoy by ALL the US patients in the control arm. 12 X 1.25= 15 months for the US control arm patients.

    7) But, the NON US control arm would still be expected to die in 12 months. Even if the number of US patients is 50% of the study size, instead of the company's best estimated # of 40%, the entire control arm mOS goes up to 13.5 months.

    8) There is some evidence that stage 3 Yervoy patients lived twice as long... OK... then let us do that calculation. 38% of the phase 3 is stage 3. To be generous let us estimate that half are in the US = 19%

    9) Now let us assume that ALL of them get Yervoy, and their OS is boosted by 100%.

    10) 19%= 24 months, 21%= 15 months 60%= 12 months TOTAL= 14.91 months mOS

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    • Instead of useless pontification.. READ and RE read... There was NO Zelboraf compassionate use program. Zelboraf was not approved until 18 months AFTER the LAST phase 3 patient was enrolled.

      So, Zelboraf has NO affect upon the control group.

      The ONLY potential life extending effect upon the control group could possibly have come from the Yervoy compassionate use program...

      So, READ.. instead of pulling your puds.

    • Appreciate the effort - the key to your analysis is the assumption that the "base" mOS is 12 months. The population recruited for this trial were intentionally in better health (i.e. normal LDH, no liver or brain mets, no prior chemo, etc.) - i.e. had a healthier immune system to provide time for the vaccine to kick in. There is no way to predict the expected survival for this group - certainly it is greater than 12 months, but hopefully less than 24?

      • 3 Replies to tredleon
      • Vicals' official estimate is 11 months for the control arm... they have a MAX estimate of 14 months.

        I added a month... ...but my 40 month A-7 arm analysis is NOT based upon a 12 month mOS for the control arm...

        Its based upon a 14.9% survival at 50 months... which equates to a mOS of about 15 months.

        Please short some more sir... Please kind sir... I would very much like some more cheap shares.

      • QUOTE from VICAL concerning the expected MEDIAN OS in the control arm of the P3

        Our best estimates come from the detail analysis also of our own Phase III study. You know, we had conducted a low-dose Phase III Allovectin, so we have a lot of our own data where we’re able to look at speculated population in the current Phase III study and that data further supports Allovectin right now. We’re very comfortable

        Please short some more... OK?

      • Vical's CEO Discusses Q2 2012 Results - Earnings Call Transcript PROXY for CONTROL arm P3

        As a proxy for Phase 3 control arm, we looked at 61% of the patients in our high dose Allovectin Phase 2 trial who received one cycle or less of treatment which should have provided minimal survival benefit.

        As another proxy of Phase 3 control arm, we looked at the normal LDH patients in our earlier Phase 3 trial which evaluated dacarbazine with and without low-dose Allovectin. Just a reminder, the Allovectin dose in that study was 10 micrograms versus 2 milligrams in this study, which is 200-fold decrease. In both of these subset analyses, the result was not substantially different from my initial control arm survival assumption of 11 months

        SAME enrollment criteria for the phase 2... except that 38% of phase 2 had prior chemo treatment...

        The phase 3 population is OLDER and SICKER than phase 2:

        Phase 2: 53% stage 3, 47% stage 4, average age of 60.

        Phase 3: 38% stage 3, 62% stage 4, average age 64.

        Nice try basher boy.... Please short some more.

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