Momenta Pharmaceuticals Announces Top-Line Part A Results From Phase 1/2 Trial Of Necuparanib In Patients With Pancreatic Cancer

Momenta Pharmaceuticals, Inc.

, a biotechnology company specializing in the characterization and engineering of complex drugs, announced top-line results from the dose-escalation component (Part A) of the Phase 1/2 trial evaluating necuparanib in combination with Abraxane® (ABX; nab-paclitaxel) and gemcitabine (GEM) in patients with advanced metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243). A dose was established to take forward into Part B (Phase 2) of the trial, which is a randomized, controlled, proof-of-concept study to evaluate the antitumor activity of necuparanib in combination with ABX and GEM, compared with ABX and GEM alone. Part A is a Phase 1 study of escalating daily necuparanib doses in combination with 125 mg/m2 ABX and 1000 mg/m2 GEM (Days 1, 8, and 15 of each 28-day cycle) in patients with metastatic pancreatic cancer. The necuparanib starting dose was 0.5 mg/kg, which was increased via a modified 3+3 design until a maximum tolerated dose was determined. ABX was added to the treatment regimen starting with Cohort 3 following release of the Phase 3 ABX + GEM data last year. Thirty-seven patients (12 patients in the first two cohorts and 25 patients in the five subsequent cohorts) received necuparanib as of data cutoff and were included in the analyses. Top-line results included: The most common (≥30% of patients) AEs included anemia, fatigue, nausea, diarrhea, and vomiting – comparable to what has been observed for ABX and GEM alone. Twelve patients were treated with the combination regimen of necuparanib, ABX, and GEM and have completed the first 28-day cycle as of data cutoff. All 12 of these patients also had at least one follow up CT scan and were considered evaluable for radiographic response. Seven (58%) achieved a RECIST partial response (PR) and an additional 4 (33%) achieved stable disease (SD). Disease Control (the # of patients with Complete Response + PR + SD / total # of evaluable patients) was achieved in 11/12 (92%). All twelve evaluable patients also had >20%; and 11/12 had >50% decreases from baseline in CA19.9 levels (a predictive biomarker for long-term outcome and treatment response in pancreatic cancer). Data have been submitted to the 2015 Gastrointestinal Cancers Symposium for consideration. "Necuparanib continues to be a promising compound with several potential and relevant mechanisms of action in pancreatic cancer, a field with limited treatment options. Based on the favorable tolerability and encouraging early signals of potential efficacy observed to date, I look forward to further exploring necuparanib in the Part B portion of the Phase 1/2 study," said David Ryan, M.D., Chief of Hematology and Oncology and Clinical Director of the Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Hospital, and Lead Investigator in the trial. "We are pleased to have achieved a dose of necuparanib in Part A that is significantly higher than the doses of low molecular weight heparins historically tested in studies conducted to evaluate the effect of heparins on survival in patients with cancer," said Jim Roach, M.D., Chief Medical Officer of Momenta Pharmaceuticals. "We are eager to begin dosing patients in the next few weeks in the Part B portion of the study. Furthermore, we look forward to presenting and publishing data from the Part A study regarding safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy over the next several months."