OncoMed Pharmaceuticals, Inc. OMED, a clinical-stage company
developing novel therapeutics that target cancer stem cells (CSCs), or
tumor-initiating cells, presented data today from the company's ongoing Phase
1a clinical trial of anti-Notch1 (OMP-52M51) in patients with certain advanced
solid tumors during an oral plenary session at the 26^th EORTC-NCI-AACR
Symposium on Molecular Targets and Cancer Therapeutics.
The purpose of the anti-Notch1 Phase 1a clinical trial is to determine a
maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity
and preliminary efficacy in patients, including patients with tumors
overexpressing the Notch1 target as measured by a predictive diagnostic test.
Among 31 patients evaluable for safety, anti-Notch1 had a manageable safety
profile. The most common adverse event was on-target diarrhea, which was
treated with supportive care. A Phase 2 single-agent dose of 1.5 mg/kg every
three weeks was established and will be used in an expansion cohort of the
Phase 1a trial that will only enroll patients with tumors that overexpress
Notch1 as measured by OncoMed's predictive biomarker assay.
"Encouraging data presented today highlight why we are enthusiastic about the
anti-Notch1 clinical program. We have successfully identified a single-agent
dose and schedule that shows a manageable safety profile as well as early
signs of anti-tumor activity," said Jakob Dupont, M.D., OncoMed's Chief
Medical Officer. "OncoMed researchers have identified a number of tumor types
where Notch1 may be contributing to tumor growth and progression. In this
study, we are using a proprietary immunohistochemistry test to assess Notch1
activation status and correlating those results to the drug's activity. We are
seeing early signs of anti-tumor activity in several patients, with the most
impressive signals observed in patients whose tumors appear to overexpress the
activated form of Notch1."
OncoMed researchers utilized an immunohistochemistry (IHC) test to quantify
Notch1 receptor activation and identified select tumor types where the
prevalence of the biomarker is estimated to occur in at least ten percent of
patients. Patients enrolling in the anti-Notch1 Phase 1a clinical trial
include these tumor types: HER2-negative breast cancer, esophageal cancer,
colorectal cancer, gastric cancer, pancreatic cancer, small cell lung cancer,
adenoid cystic carcinoma and cholangiocarcinoma.
Anti-Notch1 demonstrated early signals of single-agent anti-tumor activity in
four of the 17 patients evaluable for response at the time of data cut off. Of
the four patients to date that demonstrated clinical benefit, three had tumors
that tested positive for overexpression of the activated form of Notch1. A
partial response as measured by RECIST criteria was achieved in a 28 year-old
patient with adenoid cystic carcinoma whose cancer previously progressed after
radiation and four lines of systemic treatment. The patient's tumor tested
positive using OncoMed's IHC assay for a marker of Notch1 receptor activation.
Three other patients achieved stable disease. Of these, two patients showed
high levels of Notch1 receptor activation. One of these patients with
refractory colorectal cancer whose cancer had progressed through eight prior
lines of systemic therapy remained progression free for 294 days.
"While early, these data provide a snapshot of OncoMed's integrated
translational research and clinical development expertise. These results are
encouraging for the future development of this clinical program," said Paul J.
Hastings, OncoMed's Chairman and Chief Executive Officer. "An expansion cohort
enrolling biomarker-selected patients in the anti-Notch1 Phase 1a trial is
about to begin and will provide greater information about the potential for
anti-Notch1 as a single-agent accompanied by our biomarker assay. Data from
the Phase 1a will inform future clinical development and may serve as the
basis for an opt-in from our partner on this program, GlaxoSmithKline."
These data were presented during the Plenary Session in a presentation titled,
"Safety and early evidence of activity of a first-in-human Phase I study of
the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1)
administered intravenously to patients with selected solid tumors" (abstract
#2) by lead investigator Amita Patnaik, M.D. of the South Texas Accelerated
Research Therapeutics (START) center.
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