nontaxane microtubule dynamics inhibitor

Description Results NMA

overall survival 0.88 [0.77; 1.00] median 15.9 mo vs. 14.5 mo

PFS 1.08 [0.93; 1.25] median 4.1 mo vs. 4.2 mo

overall survival 0.81 [0.66; 0.99] median 13.1 mo vs. 10.6 mo Demonstrated

PFS 0.87 [0.72; 1.06]

eribulin mesylate 1.4 mg/m2 (equivalent to eribulin 1.23 mg/m2 [expressed as free base]) intravenously over 2 to 5 minutes on days 1 and 8 until disease progression, unacceptable toxicity, or patient/investigator request to discontinue (n=554)

vs.

capecitabine 1.25 g/m2 orally twice per day on days 1 to 14, both in 21-day cycles (n=548)

open-label

Sample size: 554/548

Primary endpoint: Co-primary OS, PFS

FU duration:

eribulin mesylate (1.4 mg/m2, 2–5 min intravenous on days 1 and 8) (n=52)

vs.

ixabepilone (40 mg/m2, 3 h intravenous on day 1) on a 21-day cycle (n=52)

open-label

Parallel groups

Sample size: 52/52

Primary endpoint: incidence of neuropathy

FU duration:

phase 2

eribulin mesilate (1·4 mg/m² administered intravenously during 2–5 min on days 1 and 8 of a 21-day cycle) (n=508)

vs.

treatment of physician’s choice (n=254)

open-label

Sample size: 508/254

Primary endpoint: overall survival

FU duration: