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Page Background

Randomized Phase 3 trial: MM-398 + 5-

FU/LV as 2

nd

-line therapy for MPC

(NAPOLI-1)

MM-398

(120 mg/m

2

Q3W)

n=151

MM-398 +

5-FU/LV

(80 mg/m

2

+ 2400 mg/m

2

over 46 h /

400 mg/m

2

Q2W)

n=117

1:1:1

5-FU/LV

(2000 mg/m

2

over 24 h / 200 mg/m

2

weekly Q6W)

n=149

MPC

Received prior

gemcitabine-based

therapy

N=417

R

Primary endpoint: OS

Secondary endpoints: PFS, ORR, CA19-9 response, safety

Stratification:

Albumin, KPS, ethnicity

Wang-Gillam et al. Lancet 2015. doi: 10.1016/S0140-6736(15)00986-1

Primary objective OS