Effective January 1, 2017 - New permanent J-code for ONIVYDE: J9205, injection, irinotecan liposome, 1 mg This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice.

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EXTENDED Overall
Survival (OS)1,2

ONIVYDE® (irinotecan liposome injection) + 5-FU/LV demonstrated a statistically significant increase in median OS vs 5-FU/LV

Overall Survival

5-FU=fluorouracil; CI=confidence interval; HR=hazard ratio; LV=leucovorin.

ONIVYDE is not indicated as a single agent for the treatment of metastatic adenocarcinoma of the pancreas1

  • There was no improvement in OS for ONIVYDE vs 5-FU/LV (HR=1.00, p=0.97 [two-sided log rank])

NAPOLI-1 was a global Phase 3, randomized, open-label, multicenter trial in patients (N=417) with metastatic adenocarcinoma of the pancreas whose disease had progressed following gemcitabine-based therapy. Patients were initially randomized to receive ONIVYDE (100 mg/m2 q3w) or 5-FU/LV. After 63 patients in the initial 2 arms were enrolled, a third arm, ONIVYDE (70 mg/m2 q2w) + 5-FU/LV, was opened for enrollment. Treatment was continued until disease progression or unacceptable toxicity.1,2

Increased Progression-
Free Survival (PFS)1,2

ONIVYDE® (irinotecan liposome injection) + 5-FU/LV achieved an increase in median PFS vs 5-FU/LV

Probability of Survival

Confirmed Objective Response Rate (ORR)1

ONIVYDE + 5-FU/LV demonstrated a confirmed ORR as a secondary endpoint of 7.7% (9/117) and 5-FU/LV demonstrated a confirmed ORR of 0.8% (1/119)1*

*Investigator assessment per RECIST v1.1.2

INDICATION AND IMPORTANT SAFETY INFORMATION

**National Comprehensive Cancer Network® (NCCN®).

References: 1. ONIVYDE [package insert]. Cambridge, MA. Merrimack Pharmaceuticals, Inc.; October 2015. 2. Wang-Gillam A, et al. Lancet. Published online November 22, 2015. doi: 10.1016/S0140-6736(15)00986-1. 3. Data on file. Merrimack Pharmaceuticals, Inc.; Cambridge, MA.

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INDICATION AND IMPORTANT
SAFETY INFORMATION