OncoMed Pharma (OMED) Announces Completion of Demcizumab Phase 2 Enrollment as Pancreatic Cancer Treatment

September 1, 2016 8:04 AM EDT

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OncoMed Pharmaceuticals Inc. (Nasdaq: OMED) announced the completion of patient enrollment of 207 patients in the randomized Phase 2 “YOSEMITE” clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of first-line metastatic pancreatic cancer. Topline results are expected in the first half of 2017.

The YOSEMITE trial was designed to assess the efficacy and safety of demcizumab in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine (standard of care) compared to standard of care alone. The Phase 2 dose of demcizumab was 3.5 mg/kg every two weeks for up to 70 days. The primary endpoint of YOSEMITE is progression-free survival. Secondary and exploratory endpoints include overall survival, response rate, pharmacokinetics, immunogenicity, safety and biomarker analyses. Patients enrolled in the YOSEMITE Phase 2 were randomized into one of three study arms receiving 1) standard of care plus one course of demcizumab, 2) standard of care plus demcizumab followed by a second course of demcizumab after a 98-day wash-out period or 3) standard of care plus placebo. The YOSEMITE Phase 2 trial was conducted at 49 clinical sites in the U.S., Europe and Australia. OncoMed initiated YOSEMITE in April 2015.

“We would like to thank the patients and their caregivers as well as the investigators and study teams for their participation and support in this trial,” said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. “Improving outcomes for patients with metastatic pancreatic cancer has proven to be highly challenging and the need for additional treatment options is of great importance. In Phase 1b studies, demcizumab combined with standard of care demonstrated promising response rates and survival trends, and we look forward to gaining further insights into demcizumab’s potential in pancreatic cancer from the Phase 2 YOSEMITE trial.”

In OncoMed’s Phase 1b clinical trial of demcizumab truncated dosing and Abraxane plus gemcitabine, 14 of 28 (50%) patients evaluable for response achieved partial responses (unconfirmed) and another 11 (39%) achieved stable disease. Among 32 patients evaluable for survival in the Phase 1b, median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received one truncated 70-day course of demcizumab with Abraxane plus gemcitabine. The combination of demcizumab and Abraxane plus gemcitabine was generally well tolerated with fatigue, nausea and vomiting being the most common drug related toxicities. Final results from OncoMed’s Phase 1b trial of demcizumab were presented at the 2016 Gastrointestinal Cancers Symposium.

About Pancreatic Cancer Pancreatic cancer is the third leading cause of cancer-related deaths. According to the American Cancer Society, each year in the United States there are approximately 49,000 new cases of pancreatic cancer and 41,000 deaths. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year.

About Demcizumab (anti-DLL4, OMP-21M18) Demcizumab is a humanized monoclonal antibody targeting Delta-like Ligand 4 (DLL4), a key member of the Notch signaling pathway. Based on preclinical studies, demcizumab appears to have a multi-pronged mechanism of action: halting cancer stem cell growth and reducing cancer stem cell frequency, disrupting angiogenesis in the tumor and augmenting anti-tumor immune responses by decreasing tumor myeloid-derived suppressor cells (MDSCs).

Demcizumab is currently being studied in two randomized Phase 2 clinical trials. The YOSEMITE trial is testing demcizumab with Abraxane plus gemcitabine versus Abraxane plus gemcitabine alone in first-line advanced pancreatic cancer patients. The DENALI trial is testing demcizumab with pemetrexed and carboplatin versus pemetrexed and carboplatin alone in first-line advanced non-small cell lung cancer patients. A Phase 1b trial combining demcizumab with the anti-PD1 antibody pembrolizumab in solid tumor patients was also initiated in early 2016. Demcizumab is part of OncoMed's collaboration with Celgene Corporation.

Patients interested in learning more about participating in one of OncoMed’s ongoing clinical trials may learn more by calling 1-866-914-7347 or emailing oncomed@emergingmed.com.

About OncoMed PharmaceuticalsOncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics. OncoMed has seven anti-cancer therapeutic candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), ipafricept (FZD8-Fc, OMP-54F28), and anti-RSPO3 (OMP-131R10), which each target key cancer stem cell signaling pathways including Notch, Wnt and R-spondin LGR. OncoMed is advancing its wholly owned GITRL-Fc candidate and an undisclosed immuno-oncology candidate (IO#2) toward clinical trials in the 2016-2017 timeframe. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK).

Additional information can be found at the company's website: www.oncomed.com.

Forward-Looking StatementsTo the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Litigation Reform Act of 1995, including OncoMed’s expectations regarding demcizumab’s potential as a treatment for pancreatic cancer; the timing of results from the YOSEMITE trial; the multi-pronged mechanism of action of demcizumab; and OncoMed’s future development plans for its product candidates and the timing thereof. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research and the clinical development process. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed’s business in general, please refer to OncoMed’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 10, 2016, OncoMed’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2016, and OncoMed’s other reports filed with the SEC.

Contact:Media & InvestorsOncoMed Pharmaceuticals Michelle CorralSenior Director, Investor Relations and Corporate Communicationsmichelle.corral@oncomed.com(650) 995-8373

Source: OncoMed Pharmaceuticals, Inc.



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