Momenta Pharmaceuticals said today it has halted further enrollment in its Phase II trial assessing necuparanib in combination with Abraxane® and gemcitabine in patients with advanced metastatic pancreatic cancer.
The company said it followed the recommendation of the trial’s independent Data Safety Monitoring Board (DSMB), which concluded that necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment.
The DSMB issued its recommendation following a planned interim futility analysis conducted upon occurrence of 57 deaths—half of the target number of 114 events required for trial completion.
Data were assessed from 120 randomized patients as of July 20, 2016. No new safety signals were observed and the toxicity profile was considered manageable, Momenta said.
“We are extremely disappointed with the outcome of the futility analysis—in particular, for those patients with pancreatic cancer where there is still so much unmet need for safe and effective therapy,” Jim Roach, M.D., Momenta’s svp of development and CMO, said in a statement.
He added that Momenta agreed with the DSMB recommendations and plans to confirm the futility analysis and determine next steps for the necuparanib program.
Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. According to Momenta, necuparanib has been engineered from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins.
While the use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity, the dose of these products has been limited by their anticoagulant activity, the company noted.
The trial was part of a two-part Phase I/II study. Part A was a Phase I, open-label, multiple ascending-dose study of necuparanib given first as a single dose and then daily in combination with Abraxane and gemcitabine.
In June at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, Momenta reported final trial data from Part A that showed favorable tolerability and promising antitumor activity based on survival and response data.
Part B is a Phase II, randomized, placebo-controlled, double-blind study investigating the antitumor activity of necuparanib combined with Abraxane and gemcitabine compared with placebo combined with Abraxane and gemcitabine.
Momenta announced the end of trial enrollment the same day it released second-quarter results. The company reported a net loss of $21 million, compared with a net loss of $2.2 million for Q2 2015, on total revenues of $26.4 million, down from $44.9 million in the year-ago quarter, a figure boosted by product and milestone revenues relating to the approval and launch of GlatopaTM (glatiramer acetate injection).