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Re: corporalagarn post# 322615

Sunday, 01/14/2018 11:50:28 PM

Sunday, January 14, 2018 11:50:28 PM

Post# of 346112
The question will come down to how much BP wants to find out whether the sunrise data set is real and if so, what is the value of treating "cold tumors".... does it increase the "footprint" of that subgroup enough to be commercially viable...

keep in mind the entire sunrise ICI subgroup was heavily weighted to less than 1% pdl 63% vs say 34% in the merck keynote 10 study... mgmt had a specific question related to "cold tumors"

And how much is it worth to answer the car-t question? And exosomes...

At the end of the day it will be whether BP can identify a population where bavi by using biomarkers ...

Keep in mind about $500 mil (or more) has been spent to date...

And 5,000 patients at $100k per treatment is $500 mil a year

and billions are at stake for BP...

So $500 mil is not a reach at all and could be much higher and it could be $5 mil.....

The issue has been terrible mgmt of the IP and taking a risk of going alone and no coverage or institutional interest or desire by prev mgmt in order to keep the gravy train... so there could be a real disconnect to value and SP... BP has beat the bastards into submission... so we will soon see what the IP is worth and we are fortunate that BP in general has the motivation to improve ICI outcomes and cash ...

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https://www.keytruda.com/static/pdf/keytruda-pd-l1-expression-testing-guide.pdf

RESULTS: 93 of 597 randomized patients (16%) received ICI as next line of therapy after SUNRISE assigned treatment. Baseline characteristics were balanced between the treatment groups and consistent with the ITT population. From randomization, mOS was not reached (95% CI, 15.2-NA) in D+B (N=46) and 12.6mos. (95% CI, 10.4-17.8) in D+P (N=47) (HR, 0.46; P=0.006). From start of ICI, mOS was not reached (95% CI, 10.2-NA) in D+B and 6.2mos. (95% CI, 3.9-8.7) in D+P (HR, 0.42; P=0.002). The mPFS was 6.0mos. (95% CI, 3.5-6.5) in D+B and 4.4mos. (95% CI, 2.6-6.3) in D+P (HR, 1.00; P=0.991). ORR was 20% vs. 13% (Odds ratio 0.6; P=0.41) for D+B and D+P, respectively. The safety profile was similar between groups and no immune related (IR) toxicities (colitis, pneumonitis, hypothyroidism) were reported.
CONCLUSIONS: Within the limits of a subgroup analysis, a significant improvement in OS was observed for patients previously treated with D+B. Furthermore, bavituximab has not been associated with IR toxicities and might serve as a useful drug in combination with ICI for the treatment of immune cold tumors.

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