OncoMed Pharmaceuticals, Inc. (OMED) announced the commencement of patient dosing in a phase II study (DENALI) on its experimental cancer treatment, demcizumab. The company is developing demcizumab for the treatment of patients suffering from first-line advanced-stage non-small cell lung cancer (NSCLC).
The double-blinded, placebo-controlled, randomized phase II study (n=200) will enroll first-line metastatic stage IV non-squamous NSCLC patients whose tumors do not have an epidermal growth factor receptor or anaplastic lymphoma kinase mutation. In this study, patients will be randomized into one of three study arms to compare the efficacy and safety of demcizumab in combination with carboplatin and Eli Lilly’s (LLY) Alimita (pemetrexed) versus carboplatin and Alimita alone.
Additionally, the phase II study will assess the pharmacodynamics and several potential predictive biomarkers. The primary endpoint of the study is progression-free survival.
We note that this is the first of two randomized phase II studies on demcizumab being conducted in collaboration with Celgene (CELG). We remind investors that in 2013, the two companies had entered into an agreement to jointly develop and commercialize up to six anti-cancer stem cell candidates from OncoMed's biologics pipeline including demcizumab.
OncoMed intends to begin patient dosing in the second phase II study on demcizumab for pancreatic cancer shortly. Meanwhile, two additional phase II studies on tarextumab (anti-notch2/3 antibody; pancreatic cancer and small cell lung cancer) are ongoing. Data from these four randomized phase II studies are expected in the 2016–2017 timeframe.
We are pleased with the company’s progress with demcizumab. According to the American Cancer Society, lung cancer is the leading cause of cancer deaths. Moreover, 40% of NSCLC patients suffer from stage IV disease.
OncoMed has a deep oncology pipeline. Apart from demcizumab and tarextumab, the company has several early-stage candidates being evaluated for multiple types of cancer. These include vantictumab (breast cancer, pancreatic cancer and NSCLC), ipafricept (ovarian cancer, pancreatic cancer and hepatocellular carcinoma) and OMP-52M51 (hematologic and solid tumor malignancies).
We expect investor focus to remain on pipeline updates from the company.
OncoMed currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Prothena Corporation plc (PRTA) carrying a Zacks Rank #1 (Strong Buy).
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