Onivyde® regimen (NALIRIFOX) demonstrated statistically significant improvement in overall survival in 1L PDAC(Supplementary information)

2023/01/21According to IPSEN’s official press release, the Onivyde® regimen (NALIRIFOX) demonstrated statistically significant improvement in overall survival in 1L PDAC.

According to IPSEN’s official press release of oral presentation at ASCO-GI Jan. 19-21 2023, the NAPOLI-3 trial demonstrated that patients randomized to the NALIRIFOX treatment regimen had a median OS of 11.1 months (95% confidence interval [CI], 10.1 - 12.1), versus 9.2 months (95% confidence interval [CI], 8.3 - 10.6) for the nab-paclitaxel plus gemcitabine control arm. (Hazard ration [HR]=0.83; 95% CI, 0.70 –0.99; p=0.04). The improvement in the primary efficacy endpoint of OS is statistically significant. The results also showed significantly improved in secondary endpoint, median PFS of 7.4 (95% confidence interval [CI], 6.0 – 7.7) months for NALIRIFOX group and 5.6 months

(95% confidence interval [CI], 5.3 – 5.8) for the control arm.(Hazard ration [HR]= 0.69; 95% CI, 0.58 - 0.83; p-value < 0.0001); ORR of 41.8% for NALIRIFOX group and 36.2% for the control arm.

Overall, the evidence of increased survival is meaningful and provides compelling evidence for efficacy of the NALIRIFOX regimen in the proposed indication over the comparator regimen. The safety profile of NALIRIFOX in NAPOLI 3 was manageable. No new safety concerns with the NALIRIFOX regimen were identified.

Ipsen intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde® in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC following the Fast Track Designation granted in 2020.

About NAPOLI-3 trial

NAPOLI-3 is a randomized, open-label Phase III trial of ONIVYDE® treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma. ONIVYDE® plus oxaliplatin and 5 -FU/LV was administered twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine administered three times a month (days 1, 8, 15 of a 28-day cycle). Approximately 770 patients were enrolled in the trial with the primary outcome measure of overall survival. Secondary outcome measures included progression-free survival, objective response rate, quality of life assessment, incidence of treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Adverse events and laboratory analyses were also analyzed.


ONIVYDE, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. PharmaEngine, Inc. has Taiwan exclusive commercial rights, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the US exclusive new indication development and commercial rights, the exclusive rights for rest of the world are owned by Servier. ONIVYDE® has been approved in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with mPDAC after disease progression following gemcitabine-based therapy in Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China since 2011. It also received orphan drug designations in the US, EU, and other countries.

About Pancreatic Ductal Adenocarcinoma (PDAC)

PDAC is the most common and aggressive type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in all stages, the majority of patients have unresectable, locally advanced, or metastatic disease at the time of diagnosis.. Currently, fewer than 20% survive longer than one year, making survival a crucial trial endpoint and overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

About PharmaEngine, Inc. (TWO: 4162)

PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, focusing on the development of new medications for the treatment of cancer. PharmaEngine, Inc. has two ongoing projects: ONIVYDE® (Irinotecan Liposome Injection) has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China, for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine; PEP07, a CHK1 inhibitor, is under development at IND ready stage. For further information, please visit the company website (


Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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