(2023/01/21) According 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.

 

 

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About ONIVYDE®

ONIVYDE® is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In ONIVYDE®, irinotecan is enclosed in tiny fat particles called 'liposomes', which accumulate in the tumor and release slowly over time.

 

ONIVYDE® is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil and leucovorin for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

 

PharmaEngine is responsible for the commercialization of ONIVYDE® in Taiwan. Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S. and Canada. Servier, an independent international pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of ONIVYDE® outside of the U.S., Canada and Taiwan.

 

About PharmaEngine, Inc.

PharmaEngine, Inc. was established in February 2003 based on the international strategic alliance concept. The Company has been adopting the "Virtual Pharmaceutical Company Business Model" to focus on the R&D of new drug developments while lowering the related risks. In addition to conducting early drug development, PharmaEngine also licenses in and leads many new drug development projects. PharmaEngine uses extensive experience in project management to accelerate clinical trials and the post-launch product marketing.

 

Media Contact: ChiHsing Chang, Spokesperson/Vice President (info@pharmaengine.com)