Fight on with increased overall survival (OS)

Proven to extend OS1

chart1TIME FROM RANDOMIZATION (MONTHS)03691215181179951208011973371271ONIVYDE®+ 5-FU/LV:5-FU/LV:# at risk:PROBABILITY OF SURVIVAL00.10.20.30.40.50.60.70.80.91.0Median OS1HR=0.68 [95% CI: 0.50, 0.93];log-rankp=0.014ONIVYDE®+ 5-FU/LV(95% CI: 4.8, 8.5)6.1MONTHS4.2MONTHS5-FU/LV(95% CI: 3.3, 5.3)A 32%REDUCTIONINMORTALITY
efficacy-chart-1-mobileTIME FROM RANDOMIZATION (MONTHS)03691215181179951208011973371271ONIVYDE®+ 5-FU/LV:# at risk:PROBABILITY OF SURVIVAL00.10.20.30.40.50.60.70.80.91.0Median OS1*HR=0.68 [95% CI: 0.50, 0.93];log-rankp=0.014ONIVYDE®+ 5-FU/LV6.1MONTHS4.2MONTHS5-FU/LV5-FU/LV:N=417

In the NAPOLI-1 trial, ONIVYDE® + 5-FU/LV increased OS by approximately 2 months compared with 5-FU/LV alone1

  • In an exploratory analysis, 1-year probability of survival was 24% with ONIVYDE® + 5-FU/LV and 17% with 5-FU/LV7
    Limitations: This should not be interpreted as a treatment difference between arms at 1 year due to potential bias and no formal statistical protection for false positive findings

*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 every 3 weeks) or 5-FU/LV. After 63 patients were enrolled, a third arm, ONIVYDE® (70 mg/m2 every 2 weeks) + 5-FU/LV, was added. Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint, median OS, was assessed with 2 pair-wise comparisons: ONIVYDE® (n=151) vs 5-FU/LV (n=149) and ONIVYDE® + 5-FU/LV (n=117) vs 5-FU/LV (n=119, post-protocol amendment). There was no improvement in OS for ONIVYDE® vs 5-FU/LV (HR=1.00, p=0.97 [2-sided log-rank]).1,2

ONIVYDE® monotherapy had no effect on OS.

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

portrait

Fight on with extended progression-free survival (pfs)

Doubled PFS vs 5-fu/lv alone1,4

chart2TIME FROM RANDOMIZATION (MONTHS)0369121518117502272011923632100ONIVYDE®+ 5-FU/LV:5-FU/LV:# at risk:PROBABILITY OF SURVIVAL00.10.20.30.40.50.60.70.80.91.0Median PFS1,2HR=0.55 [95% CI: 0.41, 0.75]ONIVYDE®+ 5-FU/LV(95% CI: 2.7, 4.2)3.1MONTHS1.5MONTHS5-FU/LV(95% CI: 1.4, 1.8)
efficacy-chart-2-mobileMedian PFS1‡HR=0.55 [95% CI: 0.41, 0.75]ONIVYDE®+ 5-FU/LV3.1MONTHS1.5MONTHS5-FU/LVTIME FROM RANDOMIZATION (MONTHS)0369121518117502272011923632100ONIVYDE®+ 5-FU/LV:# at risk:PROBABILITY OF SURVIVAL00.10.20.30.40.50.60.70.80.91.05-FU/LV:

Confirmed objective response rate (ORR)

  • ONIVYDE® + 5-FU/LV demonstrated a confirmed ORR of 7.7% (9/117) and 5-FU/LV demonstrated a confirmed ORR of 0.8% (1/119)

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 every 3 weeks) or 5-FU/LV. After 63 patients were enrolled, a third arm, ONIVYDE® (70 mg/m2 every 2 weeks) + 5-FU/LV, was added. Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint was median OS. Additional efficacy endpoints were PFS and ORR.1,2

§Investigator assessment per RECIST v1.1.2

RECIST=response evaluation criteria in solid tumors.