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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NAPOLI-1:
A Large Phase 3 Study in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed Following Gemcitabine-based Therapy1

RANDOMIZED, OPEN-LABEL CLINICAL TRIAL DESIGN2,3

417 patients randomized across 3 arms

Chart: RANDOMIZED, OPEN-LABEL CLINICAL TRIAL DESIGN

Stratification factors: albumin (<4.0 g/dL vs ≥4.0 g/dL); KPS (70-80 vs 90-100); and ethnicity (Caucasian vs East Asian vs others).2

*Per RECIST v1.1 criteria.3

The disease must have progressed after previous gemcitabine-based therapy given in a neoadjuvant, adjuvant (only if distant metastases occurred within 6 months of completing adjuvant therapy), locally advanced, or metastatic setting.3

In the Phase 3 trial, patients known to be homozygous for the UGT1A1*28 allele were started at ONIVYDE 50 mg/m2.2

KPS=Karnofsky Performance Status.

  • Trial was initiated as a two-arm study and amended after initiation of 63 patients to include a third arm, ONIVYDE + 5-FU/LV2,3
  • Comparisons between the ONIVYDE + 5-FU/LV and 5-FU/LV arms are limited to patients enrolled in the 5-FU/LV arm after the protocol amendment (n=119)2
  • Patients were balanced across a number of demographic and baseline characteristics, including prior number of therapies, age, sex, and site of metastatic disease2,3
  • Patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America, and Oceania3
  • Treatment continued until disease progression or unacceptable toxicity2

Patient Characteristics1,3

Baseline Demographics and Disease Characteristics of Patients Randomized to ONIVYDE® (irinotecan liposome injection) + 5-FU/LV Arm

ONIVYDE + 5-FU/LV & 5-FU/LV Arms Combined
N=236
Age, median years (min, max) 63 (34, 81)
Sex, male, % 58
Albumin, mean g/dL (SD) 3.97 (0.46)
KPS, %
90–100 53
≤80 47
Ethnicity, %
Caucasian 63
East Asian 30
African American/Black 3
Other 5
Prior Lines of Metastatic Therapy, %
0§ 13
1 55
≥2 33

§Patients with no prior therapy for metastatic disease were required to have received gemcitabine or gemcitabine-based therapy in the neoadjuvant/adjuvant setting.

Intention-to-treat (ITT) population.

Participants in the NAPOLI-1 Phase 3 clinical study were evenly distributed across a number of demographic and baseline characteristics.

Outcome Measures2

The primary outcome measure was overall survival (OS)2

  • OS was evaluated using 2 pair-wise comparisons: ONIVYDE® (irinotecan liposome injection) vs 5-FU/LV and ONIVYDE + 5-FU/LV vs 5-FU/LV2

Secondary outcome measures included progression-free survival (PFS), objective response rate (ORR), and safety2

  • Tumor status assessments were conducted at baseline and every 6 weeks thereafter or sooner if investigator suspected disease progression

INDICATION AND IMPORTANT SAFETY INFORMATION

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

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

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INDICATION AND IMPORTANT
SAFETY INFORMATION