- As of 2/01/2017, 52 pts were treated on study (1 each at DL1 and DL3, 7 at DL2, 2 at DL4, 4 at DL5, 24 at DL-1 and 13 at DL-2)
- 20.8% of pts remain alive at 36-month post PVSRIPO infusion, compared to 4% of an historical control.
- Four pts remain alive more than 22 months post treatment without having received any additional intervention following PVSRIPO at 57.5+, 56.4+, 27.9+ and 23.2+ months.
An important thing to keep in mind is that the patients in this phase 1 trial were treated with various doses of the virus. We can expect future trials that move forward with the approximately optimal dose to have better overall results than this trial. The first patient in this trial is now 5 years in remission.
Thank you for posting Stephen. These statistics are promising. I will be very interested to see the stats for DC PP66 and D2C7.
ReplyDeleteFound the update on D2C7. Also looks positive.
ReplyDeleteResults: Currently, 23 subjects have been treated (16 male, 7 female) with a median age of 54 years. Out of 9 dose levels, 2 subjects have been treated at every dose except for 4 at dose level 3 (120 ng/ml) and 5 at dose 6 (405ng/ml).
14 subjects are still alive with 6 remaining on study. So far, the longest survival time from infusion is 18.2+ months. Conclusions: D2C7-IT infusion via CED is safe with encouraging results. This dose escalation Phase I study is ongoing and will set the stage for the Phase II trial.
Clinical trial information: NCT02303678
http://abstracts.asco.org/199/AbstView_199_192413.html
It's hard to say from this abstract whether the results are positive. They tell us there are 14 still alive and 6 remaining on study, but no mention of how long these patients have been followed up.
DeleteLooks like it worked well in at least that one patient.
DC PP65
ReplyDeleteLong-term Survival in Glioblastoma with Cytomegalovirus pp65-Targeted Vaccination.
Summary - DC PP65 injections (at least 3) paired with dose intensified TMZ (100 mg/m(2)/d × 21 days per cycle). Of the 11 persons in the trial - results: Median PFS and OS were 25.3 months and 41.1 months, exceeding survival using recursive partitioning analysis and matched historical controls. Four patients remained progression-free at 59 to 64 months from diagnosis.
https://www.ncbi.nlm.nih.gov/m/pubmed/28411277/?
Very encouraging. This is why I've flagged the three trials at Duke and the one at Florida as being among my favorite clinical trials.
Deletehttps://clinicaltrials.gov/ct2/show/NCT02864368
https://www.clinicaltrials.gov/ct2/show/NCT02366728
https://www.clinicaltrials.gov/ct2/show/NCT02529072
https://clinicaltrials.gov/ct2/show/NCT02465268