MACK - Merrimack jumps 183% as partner Ipsen says pancreatic cancer trial met main goal

U.S. biotech Merrimack Pharma ( NASDAQ: MACK ) added ~183% pre-market Wednesday after its French partner for cancer therapy Onivyde, Ipsen S.A. ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) said that the drug as a combination therapy met the primary endpoint in a late-stage trial for a form of pancreatic cancer.

The randomized, open-label Phase 3 trial was designed to compare the effect of the Onivyde treatment regimen (Nalirifox) with chemotherapy nab-paclitaxel plus gemcitabine in previously untreated 770 patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

The experimental therapy administered twice a month met the primary endpoint indicating a clinically meaningful and statistically significant improvement in overall survival, the gold standard for measuring the efficacy of a cancer drug.

The trial, known as NAPOLI 3, also met a key secondary efficacy outcome with the Nalirifox regimen resulting in a significant improvement in progression-free survival compared to the chemotherapy regimen.

The safety profile of Onivyde was found to be in line with previous findings. Onivyde is already approved in the U.S. as a combination therapy for metastatic adenocarcinoma of the pancreas.

Ipsen ( OTCPK:IPSEY ) intends to present NAPOLI 3 data at a future medical event and file for label expansion in the U.S. to include patients with previously untreated mPDAC, which is estimated to affect nearly 60K people in the U.S. every year.

In 2017, Merrimack ( MACK ) sold Onivyde to Ipsen ( OTCPK:IPSEY ), and the company is entitled to receive $450.0M in milestone payments related to the transaction.

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