Clinical Information

RECIST Tumor Response Results

Less tumor measured by RECIST:
38% of patients achieved a
response in tumor length1

RECIST v1.1 is a linear measurement that calculates
tumor size by measuring the longest diameter of
the tumor.4

Primary endpoint: ORR measured by
RECIST at week 251,4,a

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CI, confidence interval; CR, complete response; ITT, intent to treat; ORR, overall
response rate; PR, partial response; TVS, Tumor Volume Score.

a ORR was determined by blinded independent central review (BICR).1

b Fisher’s exact test.1,2

Possibilities that may continue:
More patients responded
over time1,3,5

Within a median follow-up of 38 months, more
patients achieved responses.3,5

Exploratory analysis: More patients
responded to TURALIO over time1-5

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c An exploratory analysis measured the best overall response achieved with
TURALIO from the start of treatment until a median of 38 months
(data cutoff of May 31, 2019).3,5 The analysis of this endpoint was not included
in the prespecified statistical analysis plan to control for type 1 error3; as such,
it may be susceptible to bias.

Secondary endpoint: DOR1,2
(part 1 ITT population, n = 61)
100% of TURALIO responders achieved responses ≥6 months
(23 of 61 patients)
Median DOR was not reached at a median of 22 months
Data cutoff January 31, 2018
(range: 6.9+ to 24.9+ months)
Secondary endpoint: DOR1,2
(part 1 ITT population, n = 61)
100% of TURALIO responders
achieved responses
≥6 months

(23 of 61 patients)
Median DOR was not reached at a median of 22 months
Data cutoff
January 31, 2018
(range: 6.9+ to 24.9+ months)

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