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Immunotherapy may be the next big cancer defense line. Initial data from a slew of clinical trials treating various malignancies has researchers optimistic.
One of the first immunotherapy trials to release early data will highlight preliminary success applying ipilimumab, an FDA-approved drug already in use for melanoma, combined with a new drug, nivolumab, in renal cancer. Investigators already are planning a larger randomized trial and opened the possibility of another recognition trial, putting this therapy on the pathway to FDA approval.
While results are not yet published, preliminary positive data from the multicenter, industry-sponsored study BRMW2811 will be shared at the American Society of Clinical Oncology (ASCO) Annual Meeting and are generating excitement among the staff, says Brian Rini, MD, Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute.The drug combination showed acceptable safety and encouraging antitumor activity in renal cell carcinoma, with most responses ongoing. The data from the BRMW 2811 study will be among the first presented in wave of long-awaited immunotherapy clinical trial results.
In some patients, the immune system attempts to generate a response to cancer but cannot for some reason. The ipilimumab-nivolumab therapy, like other immune therapy approaches, is designed to stimulate the immune system, by blocking the natural inhibitor process and allowing an immune system response to malignant cells.
This particular trial combines two immune- stimulator drugs. Ipilimumab is a monoclonal antibody that binds to and blocks the action of CTLA-4, a protein that normally helps control T-cells, enhancing the immune response melanoma cells throughout the body. Nivolumab is another monoclonal antibody that binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands PD-L1 and PD-L2, resulting in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens.
Ipilimumab is approved for metastatic melanoma, while nivolumab is not yet approved in any disease. Both immunotherapy drugs are currently under study for various malignancies, including melanoma and lung, and may eventually be evaluated for almost all types of cancer, Dr. Rini says.
Cleveland Clinic enrolled 11 patients in the still active trial, fulfilling its current patient slots, and experienced success indicators. Dr. Rini notes that multiple trials for similar immunotherapy approaches are underway and still enrolling participants at Cleveland Clinic, including GNE1813, a phase II, randomized study of mpdl3280a administered as monotherapy or in combination with bevacizumab versus sunitinib in patients with untreated advanced renal cell carcinoma, and GLAX1813, a Phase I/II study to assess the safety and efficacy of MK-3475 and pazopanib in subjects with advanced renal cell carcinoma.
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