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Uveal Melanoma Phase II results revealedThe 18th International Society of Ocular Oncology Biennial Conference / NSW RANZCO Annual Scientific Meeting was held at the International Convention Centre, Sydney from 24-28 March, 2017. Results were presented on Sunday 10:37a.m. - 10.44 a.m. Check for presentations here: http://www.isoo2017.com/program-full.php A Phase II Study of Glembatumumab Vedotin for Metastatic Uveal Melanoma Sapna Patel1, Karen Perdon1, Jeanne Broussard1, Dan Gombos1, Christopher Turner3, Jeffrey Moscow2 1The University of Texas MD Anderson Cancer Center, Houston, Texas, USA, 2Cancer TherapyEvaluation Program, Bethesda, Maryland, USA, 3Celldex Therapeutics, Inc., Needham, Massachusetts, USA Purpose: Systemic treatment of metastatic uveal melanoma has been unsuccessful to date. Objective responses are rare, and improvement in survival even rarer. Targeted therapy, chemotherapy, and immunotherapy have been studied with little benefit. Antibody-drug conjugates(ADC) represent a way to deliver a chemotherapy payload preferentially to tumor cells. Glembatumumab vedotin (GV) is an ADC targeting the tumor protein GPNMB, which is expressed in 86% of primary uveal melanomas. Methods: We performed a multi-center U.S. open-label, single-arm phase II study of GV in patients with metastatic uveal melanoma (NCT02363283). Patients received GV 1.9 mg/kg intravenously Day 1 of a 21-day cycle. Objective responses were measured every two cycles using RECIST 1.1. The study planned to enroll 18 patients in the first stage. If at least one objective response was noted in the first stage, an additional 14 patients would be enrolled for a total of 32 evaluable patients. Results: In the first stage of enrolment, 17 of 18 patients went on to receive treatment. One patient demonstrated a partial response to treatment with 46% reduction in his target tumor burden in the liver, adrenal gland, and aortocaval lymph node. Conclusion: Due to the presence of at least one objective response, the study's second stage is now open for full enrollment in the U.S. In addition to clinical responses, the study will examine impact on survival and pharmacodynamic change in GPNMB expression on metastatic tumors before and after one cycle of treatment |
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Msg # | Subject | Author | Recs | Date Posted |
144 | Re: Uveal Melanoma Phase II results revealed NOT GOOD results | erin00264 | 1 | 3/30/2017 5:33:13 PM |