Genmab — Juli 2018
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Tisotumab Vedotin (TV) Program Activities
• Metastatic Cervical Cancer Trial Initiated: Seattle Genetics and Genmab initiated a phase 2 trial called innovaTV 204 in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. The trial will enroll approximately 100 patients and is intended to potentially support registration under the FDA's accelerated approval pathway. -
God morgen.
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God morgen til dagen hvor ALCYONE bliver indstillet til 1. linie godkendelse i Europa.......forhåbentlig....:-)
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Go' morgen
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Seattle Genetics (SGEN) Q2 2018 Results - Earnings Call Transcript https://seekingalpha.com/article/4190986-seattle-genetics-sgen-q2-2018-results-earnings-call-transcript?part=single
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Our third late-stage program is tisotumab vedotin. which we're developing with Genmab. We've achieved two recent milestones. We've dosed the first patient in a pivotal trial for women with recurrent or metastatic cervical cancer. And we started a Phase 2 basket trial evaluating tisotumab vedotin in other solid tumors. These trials are intended to support an initial accelerated approval pathway in cervical cancer and inform opportunities to broaden the program.
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Our third late-stage clinical program in our pipeline is tisotumab vedotin, or TV, which we are co-developing with Genmab. We recently treated the first patient with TV in the pivotal Phase 2 single-arm monotherapy trial called innovaTV 204 in women with second or third line cervical cancer. Target enrollment is approximately 100 patients and the primary endpoint is ORR. The trial is intended to support regulatory submission under the FDA's accelerated approval pathway
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We and Genmab are also planning a trial of TV in combination with other agents with a goal of understanding TV's potential in earlier lines of cervical cancer. This study will likely start in 2019, initially in the second line setting with the goal of moving into first line. Lastly, another recent accomplishment with the TV program is that we treated the first patient in a Phase 2 basket trial.
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This trial is enrolling four solid tumor types that highly expressed tissue factor including pancreatic, head and neck, colorectal, and head and neck, colorectal and non-small cell lung cancer. This study is designed to inform a potentially expanded development program of TV.
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and of interest on ADC:
Our ADC collaborators are also making substantial progress with programs using our technology, underscoring the growing importance of ADCs in the treatment of cancer. An example of this was yesterday during the GSK Q2 results and R&D update where they highlighted their BCMA ADC in multiple myeloma, which utilizes our technology. GSK presented a broad development strategy, including several pivotal trials with this ADC as monotherapy and in combination regimens.
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