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news.OncoMed Pharmaceuticals, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for the treatment of pancreatic cancer.
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Tarextumab is being tested in combination with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients.
The Phase 2 clinical trial will compare the progression-free survival (PFS) of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.
"Pancreatic cancer remains one of the most challenging malignances, with one-year survival rates at 20% for newly-diagnosed patients," said Eileen M. O’Reilly, M.D., of Memorial Sloan Kettering Cancer Center, a Principal Investigator for ALPINE. "Tarextumab has demonstrated a promising emerging therapeutic profile in early testing, and the continuing ALPINE trial will yield further insight into whether this compound can provide improved treatment options for pancreatic cancer patients."
"Tarextumab has been well tolerated in combination with standard chemotherapies. Treatment-related adverse events were mostly mild and moderate and easily managed. Encouraging signs of anti-tumor activity have also been observed, with a number of patients achieving partial responses or stable disease in the Phase 1b portion of the ALPINE study," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed.
"We are excited to advance tarextumab into the first OncoMed randomized, placebo-controlled Phase 2 study designed to measure its efficacy in patients with advanced pancreatic cancer."
OncoMed has completed enrollment in the Phase 1b safety portion of the ALPINE clinical study, which was intended to establish a maximum-tolerated dose for tarextumab in combination with Abraxane plus gemcitabine.
As reported in January at the 2014 Gastrointestinal Cancers Symposium, tarextumab has been generally well tolerated when administered with standard of care. An overall disease control rate (partial responses + stable disease) of 63% (17 of 27) was observed among patients receiving the three-drug combination.
"The initiation of the Phase 2 ALPINE clinical trial represents an important clinical milestone for OncoMed as we advance our first-in-class clinical pipeline of anti-cancer stem cell therapeutics," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed Pharmaceuticals.
"This is the first of four randomized Phase 2 trials we expect to commence in the next nine months and each one brings us closer to proof-of-concept data, as well as the potential for our partners to exercise their option for late-stage development."
Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.