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June 1, 2014
18:23 EDTIMMUImmunomedics reports final efficacy results of Phase Ib trial
Immunomedics reported an overall disease response rate of 41%, including 2 patients with partial response and 10 patients with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90, in combination with low-dose gemcitabine as a radiosensitizer. This was compared to a control group of 29 similar patients who received 90Y clivatuzumab tetraxetan without low-dose gemcitabine. Treatment responses were assessed by computed tomography based on RECIST criteria. Results from the multicenter Phase Ib study were presented by Vincent J. Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, at the 2014 Annual Meeting of the American Society of Clinical Oncology, ASCO. Within the 2 subgroups of patients, adding low-dose gemcitabine extended the median overall survival for the 29 patients in Arm A to 3.9 months, a statistically significant improvement compared with the 2.8 month median OS for the 29 patients receiving only 90Y-clivatuzumab tetraxetan in Arm B. Furthermore, for patients in Arm A, there were 48%, 34%, 21%, and 10% of patients alive at 3, 6, 9, and 12 months, respectively, indicating that the combination of radiolabeled antibody and gemcitabine improved survival throughout the study. "Based on these encouraging results, we have launched the Phase III PANCRIT-1 registration trial, positioning 90Y-clivatuzumab tetraxetan as a therapy for patients in this late-stage setting," commented Cynthia L. Sullivan, President and CEO of Immunomedics. "The primary end-point will be overall survival and the protocol allows the independent Data and Safety Monitoring Board one planned interim analysis of data on overall survival to be conducted after a predetermined number of events have occurred. We plan to complete patient accrual by the second half of 2015, with top-line results expected in the first half of 2016," Ms. Sullivan reiterated.
News For IMMU From The Last 14 Days
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January 29, 2015
08:35 EDTIMMUImmunomedics announces dismissal of class action lawsuit
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January 20, 2015
08:46 EDTIMMUImmunomedics reports Phase 1/2 results with sacituzumab govitecan
Immunomedics announced that sacituzumab govitecan, the company's lead investigational antibody-drug conjugate, or ADC, produces partial response, or PR, in some patients with metastatic esophageal and colorectal cancers who had been heavily pretreated. Extended periods of stable disease were also noted in some patients with pancreatic and gastric cancers, with time-to-progression, or TTP, exceeding that of last prior therapy in many cases. Response and TTP were evaluated by computed tomography, or CT, based on RECIST criteria. Patented and developed by the company, sacituzumab govitecan was created by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan, which is used to treat certain solid cancers, particularly metastatic colorectal cancers, as a part of combination therapies, so its pharmacology and properties are well-known. Despite the late-stage setting, 1 patient in each of the colorectal and esophageal cancer groups had a partial response after receiving more than 2 doses of the ADC. For all 4 cancer types, the disease stabilization rate exceeded 50%.

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