Momenta Pharmaceuticals ($MNTA) has stopped a Phase II pancreatic cancer trial of necuparanib following an interim futility analysis. The data and safety monitoring board (DSMB) ran the analysis once 57 patients in the 120-person trial had died, leading to the conclusion that necuparanib was showing insufficient efficacy to justify continuing the study.
Cambridge, MA-based Momenta built the interim review into the trial to give the monitoring board a chance to assess the data once half of the 114 events needed for study completion had occurred. At that point, which was marked by the 57th death in the trial, the DSMB took a look over the data. The conclusion was that necuparanib, while having a manageable toxicity profile, was failing to have a meaningful effect on outcomes in the patients.
That conclusion led the DSMB to recommend halting enrollment in the study, although the lack of toxicity concerns meant it saw no reason to stop treatment of patients already taking necuparanib. The next step is to unblind the data and figure out the future for necuparanib, if it has one. Shares in Momenta fell 7% following the news.
Momenta was trialing necuparanib in combination with Celgene’s ($CELG) Abraxane and the chemotherapy drug gemcitabine. In the first part of the Phase I/II trial, 9 of the 16 patients who completed one cycle of this combination had a partial response. Approximately one-third had stable disease. These data encouraged Momenta to advance into a larger Phase II study, data from which were due to drop in the second half of 2017.
That Momenta has stopped the trial long before this date is a blow to its hopes of building a pipeline of innovative therapeutics. Necuparanib was spearheading Momenta’s advance into novel drugs. If necuparanib ends up on the scrap heap, Momenta will be left with a Phase I autoimmune disease candidate, plus a small portfolio of generic medicines and a clutch of biosimilars.
The failure of necuparanib also represents another blow to pancreatic cancer patients. Momenta joins Incyte ($INCY) on the list of drugmakers to discontinue pancreatic cancer trials following interim analyses this year. Like Momenta, Incyte halted its study after the analysis found a lack of efficacy. Aduro Biotech ($ADRO) and NewLink Genetics ($NLNK) have also posted negative data in recent months. Standard of care actually outperformed the experimental drugs in some situations in the Aduro and NewLink trials