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Re: DewDiligence post# 195271

Monday, 12/14/2015 5:01:57 PM

Monday, December 14, 2015 5:01:57 PM

Post# of 257432
BIND -33% on failure of mutant-KRAS cohort in phase-2 NSCLC:

http://finance.yahoo.com/news/bind-therapeutics-advance-bind-014-123000277.html

BIND Therapeutics, Inc…today announced that the squamous histology non-small cell lung cancer (NSCLC) cohort of the phase 2 iNSITE 1 trial will advance to the second stage and complete enrollment to 40 patients. The company also announced that the KRAS mutant NSCLC arm will not advance to the second stage. The rationale for these decisions is based on safety and efficacy data from the planned interim analysis of iNSITE 1 as well as updated overall survival (OS) data in the squamous cohort from the previous clinical trial in the broad NSCLC population, the BIND-014-005 trial.

In the KRAS mutant cohort, data from 23 patients in ITT population and 14 patients from the PP subset demonstrated an interim 6wDCR of 17.4 percent (95% CI, 5% to 39%) and 28.6 percent (95% CI, 8% to 58%) respectively, which did not meet pre-specified criteria to move to the second stage of the iNSITE 1 trial. The overall response rate (ORR)…was 4 percent (ITT) and 7 percent (PP).


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