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Significant Sarcoma Trial UpdateYou may recall that at the Q1 call the HC Wainwright analyst asked whether there was any progress to report on the sarcoma trial. Mary T responded that because the trial was investigator sponsored, the lead investigator, Dr. D’Angelo, controlled the release of any data, and she had yet to disclose when she might present data. The trial has an estimated completion date of September 2019, so any data release may not occur for a long time. However, the latest update on CT.gov provides IMO highly encouraging news: the trial is increasing the number of patients from 60 to 100 and, perhaps more importantly, is adding a pediatric arm (enrolling patients aged 12 – 17). Here is a link to the CT archive comparing the current listing of the trial with the prior version. https://www.clinicaltrials.gov/ct2/history/NCT03282344?A=5&B=6&C=Side-by-Side
Note that sarcoma tumors are
“cold” and it was the nivo/214 combo’s ability to turn cold tumors hot that,
according to Mary T., led Dr. D’Angelo to approach NKTR and BMS in 2017 to
approve the trial. The trial began in September, so the combo would seem
to be working well enough and quickly enough to stimulate the trial’s significant
expansion at this point. I also hope it means we will see data well before
September 2019.
Also recall that Mary T during a
2017 quarterly call remarked that good results in any of the types of sarcomas
that will qualify patients for the trial – there are at least 6 types -- could lead to an AA.
Another trial note: the 358
P1 trial in lupus patients now appears on CT.gov.
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Msg # | Subject | Author | Recs | Date Posted |
852 | Re: Significant Sarcoma Trial Update -- registrational trial plannded for first half of 2019 | stockbettor | 2 | 8/14/2018 7:54:27 PM |