- Ipsen SA IPSEY announced that the Phase 3 NAPOLI 3 trial of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) met its primary endpoint.
- The combination therapy demonstrated a clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
- Progression-free survival (PFS) also showed significant improvement over the comparator arm.
- In reaction to the news, Merrimack Pharmaceuticals Inc MACK shares are up over 200%.
- In 2017, Ipsen gained exclusive commercialization rights for the current and potential future indications of Merrimack's pancreatic cancer drug Onivyde.
- Ipsen agreed to pay $575 million cash at closing plus up to $450 million upon the approval of potential additional indications for Onivyde in the U.S.
- In August, the companies reported a primary analysis of the Phase 3 trial of Onivyde for second-line small cell lung cancer (SCLC).
- The study did not meet the primary endpoint of overall survival in patients treated with Onivyde versus topotecan.
- However, a doubling of the secondary endpoint of the objective response rate in favor of Onivyde was observed.
- Price Action: MACK shares are up 243% at $13.72 during the premarket session on the last check Wednesday.
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