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OncoMed Announces Interim Phase 1b Results for Navicixizumab and Paclitaxel Combination Therapy in Platinum-resistant Ovarian CancerOverall Clinical Benefit Rate of 85%, Partial Response Rate of 42% and Progression Free Survival of 5.4 Months Observed in Patients with > 2 Prior Therapies and/or Prior Bevacizumab REDWOOD CITY, Calif., Oct. 20, 2018 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced interim results from its ongoing Phase 1b trial investigating navicixizumab, OncoMed’s anti-DLL4/VEGF bispecific antibody, in combination with paclitaxel in patients with platinum-resistant ovarian cancer. The interim results were presented at the European Society for Medical Oncology in Munich. The patients had received a median of four prior therapies, all of whom had received prior paclitaxel and 69% had received prior bevacizumab. Twenty-two of the 26 patients (85%) treated with the novel regimen experienced clinical benefit. Notably 11 of the 26 patients (42%) achieved a partial response and the median progression-free survival was 5.4 months (95% CI: 3.5-8.0 months). Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less. “These are impressive results that warrant further evaluation in this historically difficult-to-treat patient population,” said Kathleen Moore, M.D., Jim and Christy Everest Endowed Chair in Cancer Research, Clinical Research Director, University of Oklahoma Health Science Center and one of the lead investigators for the Phase 1b clinical trial. “When ovarian cancer stops responding to platinum-based therapy, our best option is chemotherapy plus bevacizumab, which may be effective, but often for only a short duration. Following this line of therapy, there are no approved, effective options for patients. Combination weekly paclitaxel and navicixizumab appears to provide durable responses among patients with multiple lines of prior therapy and/or prior exposure to bevacizumab, which represents a high unmet need.” The ongoing Phase 1b multicenter, open-label, dose-escalation and expansion trial is designed to assess the safety, preliminary efficacy, immunogenicity, pharmacokinetics and biomarker effects of navicixizumab plus paclitaxel. The trial has been expanded to enroll up to 60 patients with platinum-resistant ovarian cancer (including fallopian tube or primary peritoneal cancers) who have previously received bevacizumab and/or have failed at least two prior therapies. Additional highlights from the poster were:
OncoMed's anti-DLL4/VEGF bispecific antibody, navicixizumab, is designed to inhibit the function of both DLL4 and VEGF and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. Navicixizumab was developed utilizing OncoMed's BiMAb™ bispecific platform technology, which enables the design of bispecific antibodies comparable to traditional monoclonal antibodies but possessing dual target-binding specificity. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. Further, in preclinical studies dual inhibition of DLL4 and VEGF appeared to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity. In a Phase 1a study with single-agent navicixizumab published in Investigational New Drugs, 19 of 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy. About OncoMed Pharmaceuticals Forward Looking Statements
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