Genmab — Oktober 2019
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God morgen.
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Fra SGEN Q3 rapport i går: Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected in 2020: Seattle Genetics and Genmab previously reported the completion of enrollment in the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Topline data from the trial are expected in the first half of 2020.
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thks GB and to add from the transcript: Q: So, you mentioned the upcoming trial results for the TV study in cervical cancer from the - TV-204 trial. Can you just remind us of sort of expectations for what are the clinical bars here in terms of efficacy for approvability?
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Clay Siegall
There is a lot there and maybe I'll give you a few comments, but Roger can also follow up. And if you look at relapsed cervical cancer, it's a grim prognosis, no one survives this. This is bad, and despite Carticel and vaccines. Not everyone gets vaccine across the globe and in the U.S. and so there is still unfortunately a need for therapies for relapsed cervical cancer.
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And if you look at perhaps the most recent approval in cervical cancer, it was pembro and PD-1 high-expressers with a 14, that's 14% response rate, but they were durable responses. And if you look at chemotherapy that has been used in a lot of publications, there are, I would say the range is probably somewhere between 8% and maybe 16%, 17%
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response rate sometimes with durations that are tiny measured in two months of duration whereas with a checkpoint you can get a year or so of duration, which is likely why it got approval, even with the de minimis response rate because it had duration.
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So, I think those maybe can help you give you some landmarks of what's out there and clearly we want to do well by patients and have the best response we can have with single agent, look at this in future in combination. Roger, do you have any color that you want to add beyond that?
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From Q2 CC Jan said this:We also watching the landscape very, very carefully for next-generation technologies, which we think would complement our technology base, Emily. And of course, with the cash now on the bank, we actually -- we can actually move very swiftly and very quickly to actually broaden the technology base of the company, both product-wise and technology-wise. And you'll see examples of each one of those in the coming time, I believe
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