▎WuXiEdited by Kant Content Team

Recently, Ipsen announced that the U.S. FDA has approved the supplemental New Drug Application for its medication Onivyde in combination with the NALIRIFOX chemotherapy regimen (including 5-fluorouracil/leucovorin, and oxaliplatin) as a first-line treatment for adult patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).According to the press release, Onivyde is the first FDA-approved treatment regimen that has demonstrated efficacy in treating mPDAC in two Phase 3 trials across different treatment lines.

The approval by the U.S. FDA is primarily based on the efficacy and safety data from the NAPOLI 3 trial, a randomized, open-label, Phase 3 pivotal trial that enrolled a total of 770 participants. The study met its primary and secondary endpoints. Key results from the trial are as follows:

• The median overall survival (mOS) for patients receiving NALIRIFOX combination therapy (n=383) was 11.1 months (95% CI: 10.0-12.1), compared to 9.2 months (95% CI: 8.3-10.6) for those treated with nab-paclitaxel and gemcitabine (n=387), with a statistically significant difference between the two groups.（HR=0.84，95% CI：0.71–0.99；p=0.0403）。

• Using NALIRIFOXCombination TherapyThe median progression-free survival (mPFS) was 7.4 months (95% CI: 6.0-7.7) in the patient group, compared to 5.6 months (95% CI: 5.3-5.8) in the control group, with a statistically significant difference between the two groups.（HR=0.70，95% CI：0.59–0.85；p=0.0001）。

• Receiving NALIRIFOXCombination TherapyThe objective response rate for treated patients was 41.8% (95% CI: 36.8-46.9), compared to 36.2% (95% CI: 31.4-41.2) in the control group.

• The safety of the Onivyde regimen is manageable and consistent with the safety profile of the therapeutic agent, but serious adverse events such as fatal neutropenic fever and severe diarrhea may occur.

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Onivyde is a topoisomerase inhibitor, irinotecan liposome injection.Onivyde can remain in systemic circulation for an extended period, with a total irinotecan half-life of 25.8 hours after drug injection, significantly longer than non-liposome-encapsulated irinotecan. Onivyde enters cancer cells through natural means (liposome-enhanced cellular permeation and retention effect). Once irinotecan is released from within the liposomes, it becomes toxic to cancer cells. In 2020, Onivyde received FDA Fast Track designation in the United States for use in combination with 5-fluorouracil/leucovorin as a first-line treatment for patients with mPDAC.

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References:

[1] Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA. Retrieved February 14, 2024 from https://www.ipsen.com/us/press-releases/ipsens-onivyde-regimen-a-potential-new-standard-of-care-first-line-therapy-in-metastatic-pancreatic-adenocarcinoma-approved-by-fda/

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