Genmab — Juni 2017
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"The preliminary data we see in patients with cervical cancer treated with tisotumab vedotin are encouraging. We believe further development of this novel antibody-drug conjugate may be warranted in cervical cancer and are actively looking into possible next steps," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
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Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjuga
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conjugates (ADC), including peripheral neuropathy and neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin specific toxicity, which led to introducing of prophylactic management. In the cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse events: gastro-intestinal related (5 patients), anemia (2 patients), infections (1 patient), neuropathy (2 patients), bleeding (2 patients), other (10 patients).
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waaaad!? - nye kliniske data fra GEN!
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mon det er trigger til at SGEN skal bestemme sig?
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Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study
Company Announcement Preliminary data shows responses achieved in 11 of 34 evaluable patients with cervical cancer treated with tisotumab...
GlobeNewswire News Room (globenewswire.com)
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ingen usædvanlig tox i studiet
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I am not 100% sure this is the correct place to watch on FDA site, but this was just updated to inclued 16 June and Dara is not there https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
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