InvestorsHub Logo
icon url

James salmon

06/01/18 9:52 AM

#69628 RE: James salmon #69627

Clearly Keytruda trial is not including patients as heavily pretreated as Advaxis trial.

This is criteria for Keytruda trial:

Criteria
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. Disease must be either metastatic or locally confined inoperable disease that cannot be treated with definitive intent (no chance for a curative intervention).
Has supplied tumor tissue from a newly obtained biopsy or a biopsy obtained ≤12 months prior to study start and an archival specimen, if available, from a site not previously irradiated. Participants in Cohorts 1, 2, and 4 with visceral/measurable lesions must provide a newly obtained biopsy performed after the last line of systemic therapy or a biopsy obtained ≤12 months prior to study start and an archival specimen, if available. Participants in Cohorts 3 and 5 must at least provide an archival specimen.
For Cohorts 1, 2, and 3 only:
Has been treated with:
At least 1 targeted endocrine therapy (defined as second generation antiandrogen therapies that include but are not limited to abiraterone acetate with prednisone, enzalutamide, and next generation targeted agents such as ARN-509).
At least 1 regimen/line of chemotherapy that contained docetaxel.
No more than 2 chemotherapy regimens.
No more than 3 regimens/lines of the aforementioned treatments (having failed/progressed on chemotherapy and targeted endocrine therapy).
icon url

fbg0316

06/01/18 10:00 AM

#69632 RE: James salmon #69627

Thanks James, this is encouraging looking at the separate Merck monotherapy next to our monotherapy data and the combo data. While we can't directly compare the Merck monotherapy data to our recent monotherapy data because of different populations and pre-treatment regimes, generally speaking it would appear that our monotherapy data is within the ballpark of Merk's monotherapy data, but combined the two therapies represent a meaningful improvement. Hovacre may want to weight in from a scientific background.

Merck PD1 Prostate Monotherapy = 19% PSA declines
ADXS PSA Prostate Monotherapy = 15.4% PSA declines
Merk & ADXS Combined Therapies = 40.5% PSA declines