Merrimack scores hit with pancreatic cancer treatment
US firm Merrimack has announced encouraging late-stage results for its pancreatic cancer treatment MM-398.
The company, headquartered in Cambridge, Massachusetts suffered setbacks to its pipeline last year when another drug, MM-121 recorded three consecutive failures, in breast, ovarian and lung cancer.
Now the firm is upbeat once again thanks to the 1.9 month improvement in overall survival achieved by MM-398 compared to standard therapy in metastatic pancreatic cancer. The drug was studied in patients with metastatic pancreatic cancer who received prior gemcitabine-based therapy.
This increase, though modest, is statistically significant, and is significant in the wider sense because pancreatic cancer has proven to be one of the most hard to treat tumour types.
"We are excited by the results of the NAPOLI-1 study because of the critical need to help patients with this devastating illness and are moving forward as quickly as possible to get MM-398 to patients," said Robert Mulroy, president and chief executive of Merrimack.
"Given that there have only been a handful of successful Phase 3 trials in pancreatic cancer in the past 25 years, it is gratifying to have the first positive Phase 3 trial in the post-gemcitabine setting," Mulroy added.
He said that the results also reinforced the firm's confidence in its entire pipeline of drugs which use nanoliposomal technology. The novel drug delivery approach involves encapsulating the existing chemotherapy drug (in this case irinotecan) in a liposome, which helps the drug reach tumours more effectively.
The NAPOLI-1 trial is a randomised, open label Phase 3 study in patients with metastatic pancreatic cancer who received prior gemcitabine-based therapy. The study looked at two MM-398 regimens, 80 mg/m2 combined with 5-FU and leucovorin every two weeks, and 120 mg/m2 as a monotherapy every three weeks. Each arm was compared to a control arm of 5-FU and leucovorin.
Merrimack expects to submit a New Drug Application to the FDA for the MM-398 combination regimen in 2014. While Merrimack's other drug MM-121 is being co-developed with Sanofi, MM-398 was licensed by Merrimack from Taiwan-based PharmaEngine.
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