Genmab — September 2017
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God morgen.
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https://labiotech.eu/jan-van-de-winkel-genmab-interview/ Interview med Winkel
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Her er lidt flash "On Friday afternoon at ESMO in Madrid, Dr Vergote et al presented updated ph I/II data for Genmab/Seattle Genetics’ tissue factor ADC Tisotumab Vedotin (TV) in advanced cervical cancer. Following the presentation of the data, Dr Mansoor Mirza also provided an independent review/discussion of the data as well as his view on the next steps for this drug, the potential regulatory route as well as the potential for this drug if eventually approved. Overall, the updated data for TV
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showing an overall response rate (ORR) of 32% with a long duration of response in these heavily pre-treated and extremely sick patients, were very encouraging and the independent data reviewer highlighted that this drug could have a future position as the standard of care in cervical cancer. In that respect, it must be noted that despite Avastin getting approved in 2014 on top of chemo for cervical cancer, the improvement in survival for these patients has been extremely modest over the past sev
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several decades – hence the unmet medical need is huge. We do not yet include TV in our Genmab valuation, but it could offer significant potential if it is positioned as the new standard of care for cervical cancer (likely up to USD ~1bn in peak sales). We remain buyers of Genmab."
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32% ORR in advanced Cervical Cancer looks very promisingDr Vergote et all presented very encouraging data for Genmab/Seattle Genetics’ tissue factor conjugated antibody (ADC) in advanced Cervical Cancer on Friday at ESMO. As can be seen from the waterfall plot in Figure 1 below, the overall response rate (ORR) was 32% and as illustrated in Figure 2, this is strongly above what is normally seen for this type of advanced cervical cancer patients. What is also highly encouraging from the TV ph I/II
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trial, also highlighted by the independent reviewer, is that almost all of the patients saw a tumour shrinkage and that treatment with TV yielded a 50% disease control rate (CR+PR+SD). Furthermore, the median duration of response was more than eight months.
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Lastly, we believe it is important to note the patient characteristics with regards to prior treatments when looking at the efficacy observed in the ph I/II TV trial. Besides the patients being very sick, we note that 71% of the patients also had received Avastin and 68% of patients had received the treatment regimen from the GOG-0240 trial with Avastin, which led to the approval of Avastin in cervical cancer. This is an important observation when discussing next steps for TV, as we do below.
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Strålende. Det lugter lidt af btd på carporten
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Tak for det jky
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Side-effects look manageable, in particular after modification measures
There is no doubt that TV seems to be effective in cervical cancer, but the drug also carries a certain amount of side effects. However, we believe that they look manageable, and that was also highlighted during the session on Friday. The most common side effects are eye related, in particular conjunctivitis, which is rather common for drugs using the MMAE chemotherapy as payload. The side effect plot is illustrated in Figur -
However, we also highlight that following certain mitigation measures in the ph I/II trial, the side effect prevalence decreased a lot – as seen in Figure 5 below. The mitigation measures included prophylaxis with steroid and lubricating eye drops, cooling masks during drug infusion and a stricter dose adjustment. As can be seen, the rate of conjunctivitis dropped to 32% versus 50% following the implementation of the mitigation measures. We also note that there was no keratitis
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(inflammation of the cornea - the clear, dome-shaped tissue on the front of your eye that covers the pupil and iris) seen in the trial, which supports our view that the side effect profile is manageable. Lastly, in such a pre-treated and severely sick group of patients, and even in earlier lines of cervical cancer, we do not believe that the side-effect profile of TV seems to be a big issue.
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Novod fasthold
er kursmål
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