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Posted On: 04/30/2019 5:51:33 PM
Post# of 36566
These are the newly reported interim results of the E75 (aka NeuVax and aka Nelipepimut-S or NP-S) vaccine Phase III:
http://clincancerres.aacrjournals.org/content...CR-18-2867
Last year, Sellas said: “The decision to early terminate this Phase 2b study was based in part on the previously announced recommendation of the independent Data Safety Monitoring Board (DSMB) to further advance the development of the NeuVax + Herceptin combination for the triple negative breast cancer (TNBC) patient population.
https://www.sellaslifesciences.com/investors/...fault.aspx
I asked then when is a large study terminated unless something is actually wrong? Now we know:
“There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm (P=0.069). Conclusions: NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination. Trial registration ID: NCT01479244.”
http://clincancerres.aacrjournals.org/content...CR-18-2867
Last year, Sellas said: “The decision to early terminate this Phase 2b study was based in part on the previously announced recommendation of the independent Data Safety Monitoring Board (DSMB) to further advance the development of the NeuVax + Herceptin combination for the triple negative breast cancer (TNBC) patient population.
https://www.sellaslifesciences.com/investors/...fault.aspx
I asked then when is a large study terminated unless something is actually wrong? Now we know:
“There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm (P=0.069). Conclusions: NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination. Trial registration ID: NCT01479244.”
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