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Additional Efficacy Endpoints

Eribulin (n=228)

Dacarbazine (n=224)

PFR

12wks

, % (n) [95% CI*]

OR (95% CI);

P

-value

33.3% (76) [27.2-39.9]

28.6% (64) [22.8-35.0]

1.3 (0.8-1.9); 0.253

ORR; % (n)

3.9 (9)

4.9 (11)

Best overall response

Eribulin (n=228)

% (n)

Dacarbazine (n=224)

% (n)

CR

PR

SD

PD

NE/Unknown

0

3.9 (9)

52.2 (119)

39.0 (89)

4.8 (11)

0

4.9 (11)

47.8 (107)

39.3 (88)

8.0 (18)

Tumor assessments based on RECIST v1.1.

1

*95% CI calculated using exact method of binomial distribution.

P

-value and odds ratio calculated using the stratified Cochran-Mantel-Haenszel method.

CR, complete response; NE, not evaluable; OR, odds ratio; ORR, objective response rate; PD, progressive disease; PFR

12wks

, progression free rate

at 12 weeks; PR, partial response; SD, stable disease.

1. Eisenhauer et al, Eur J Cancer 2009.

Schöffski P, et al. Presented at ASCO 2015 Annual Meeting, Chicago IL, June 3-7, 2015:abstr LBA10502