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Re: How about this huge international p2 trial?Re: p1 BAY94-9343. "Anetumab Ravtansine Study Posted on September 18, 2015 Last week, at the World Conference on Lung Cancer, Dr. Raffit Hassan presented promising data on a novel agent, anetumab ravtansine, also known as BAY 94-9343. Anetumab ravtansine is an antibody-drug conjugate directed against the target molecule mesothelin which is highly expressed on mesotheliomas. “Anetumab ravtansine shows encouraging efficacy in patients with advanced mesothelioma which warrants further study,” stated Dr. Hassan, a senior investigator and the head of the Thoracic and Solid Tumor Immunotherapy Section at the National Cancer Institute who has been working on developing mesothelin targeted therapies for patients with mesothelioma and other cancers for the last two decades. This was a phase I study to determine the safety and activity of anetumab ravtansine in patients with cancer who had failed standard therapies. Based on early results of this trial more mesothelioma patients were enrolled to better define the activity of this drug in patients with pleural mesothelioma who had progressed on chemotherapy. Out of the 16 mesothelioma patients treated at the maximum tolerated dose, 5 (31%) had objective tumor shrinkage while 7 (44%) had stable disease. However, out of the 10 mesothelioma patients who received anetumab ravtansine as second line therapy 5 (50%) had objective tumor shrinkage and 4 (40%) had stable disease. In most patients the tumor response was very durable with three patients still receiving the drug more than 2 years after starting therapy. Antibody-drug conjugates (also known as ADCs) are a new class of drugs that function by linking a particular antibody to a cancer-fighting drug. When combined, the antibody precisely targets the cancer cell, delivering the drug directly to it, thus avoiding extensive damage to healthy cells typical of traditional chemotherapies." To reitterate p1 results of interest, ones that appear to be inputs to the p2 trial: "However, out of the 10 mesothelioma patients who received anetumab ravtansine as second line therapy 5 (50%) had objective tumor shrinkage and 4 (40%) had stable disease. In most patients the tumor response was very durable with three patients still receiving the drug more than 2 years after starting therapy." P2 results reported re: Vinorelbine(Navelbine) "June 28, 2000 by American Society of Clinical Oncology Phase II Study of Vinorelbine in Patients With Malignant Pleural Mesothelioma Jeremy P. C. Steele, Jonathan Shamash, Marie T. Evans, Nicole H. Gower, Marc D. Tischkowitz and Robin M. Rudd - Author Affiliations From the Department of Medical Oncology, St Bartholomew’s Hospital, and the London Lung Cancer Group, London, United Kingdom. Address reprint requests to Jeremy P.C. Steele, MD, MRCP, Department of Medical Oncology, St Bartholomew’s Hospital, West Smithfield, London EC1A 7BE, United Kingdom; email j.p.steele@ mds.qmw.ac.uk. Abstract PURPOSE: To evaluate the response rate and impact on quality of life of vinorelbine given as cycles of 30 mg/m2 weekly for 6 weeks to patients with malignant pleural mesothelioma. PATIENTS AND METHODS: Twenty-nine patients with histologically proven malignant pleural mesothelioma were enrolled (26 male patients and three female patients; median age, 58 years [range, 29 to 77 years]). Seventeen patients had epithelioid tumors, two had sarcomatoid tumors, and 10 had biphasic tumors. The International Mesothelioma Interest Group staging system was used: one patient had stage Ib disease, 10 had stage II disease, eight had stage III disease, and 10 had stage IV disease. Patients were treated with weekly injections of vinorelbine 30 mg/m2. A cycle consisted of six weekly injections. The new guidelines to evaluate the response to treatment in solid tumors were used. Responses were measured by spiral computed tomography scan. RESULTS: All twenty-nine patients had measurable disease and were assessed for response. There were seven partial responses (24% [95% confidence interval, 10% to 44%]), 16 patients had stable disease (55%), and six patients had disease progression on therapy (21%). The median number of vinorelbine injections was 12 (range, 2 to 30). Quality-of-life analyses showed a benefit for vinorelbine therapy. CONCLUSION: Vinorelbine shows promise in the palliation of patients with malignant pleural mesothelioma. The relatively low toxicity of the drug suggests that trials of vinorelbine in combination with other agents should be feasible." From impressive size of this worldwide trial it looks like Bayer has high hopes of outdoing vinorelbine. When trial gets underway, IMGN should receive milestone. By early 2016 BT062 should be progressing, i.e. while Kadcyla continues to be administered without significant problems, new IMGN technology based drugs are stepping up to the plate. Partnered- and wholly owned pipelines are looking good. |
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