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22/2 16:34
af Helge Larsen/PI-redaktør
This session have ended.
22/2 16:33
af Jan Van de Winkel
Thank you for your time, we look forward to 'speaking' with you in the next Q.
22/2 16:32
af Jan Van de Winkel
Thank you for this question. We have still not reached median PFS in the Pollux (and Castor in one prior treatment) so the longer it takes to get to these medians the better the OS should be. This is unusually exciting and should keep people focused on further data.
22/2 16:31
af Helge Larsen/PI-redaktør
Jan, David and Judith. This was all we had for you this time. Thank you for joining us and thank you for the many fulfilling answers to the broad range of interested questions from our investors here at ProInvestor. com. We look very much forward to having you back again here for a Q&A in the near future after Q1.
22/2 16:31
af Jan Van de Winkel
in addition there is monotherapy retreatment data published from studies in Scandinavia.
22/2 16:31
af Jan Van de Winkel
There is very good data on retreatment in various settings, in the public domain (eg the Pollux and Castor data at ASH 2017) showing good PFS2...
22/2 16:29
af Jan Van de Winkel
This needs to be the last question unfortunately....
22/2 16:29
af LSD-GPM
Mr. Winkel, Amgen has recently updated Kyprolis label to show OS benefit, when OS data of Castor and Pollux could be expected ?
22/2 16:29
af Jan Van de Winkel
The data of the Ohio State study are in the public domain and we have heard from doctors that they are already using this 90 min infusion.
22/2 16:29
af LSD-GPM
Mr. Winkel, with the potential approval of D-VMP in the EU, Darzalex is likely to be used in front line, how does this affect DRd and DVd? Is it possible to re-treat patients with Darzalex?
22/2 16:29
af Jan Van de Winkel
This study is actively ongoing.
22/2 16:29
af bdavis
The Daratumumab 90-minute infusion seems exciting. How soon would this be available to US patients and are there any ongoing clinical trials?
22/2 16:28
af Jan Van de Winkel
12 programs have been activated and 8 clinical candidates have been selected. We expect Janssen to report on further progress with these progs in 2018.
22/2 16:27
af GeorgeBest
About a year ago there was some fantastic patient stories about dara in NKTCL (nasal type). Since then we have not heard much. When do you expect to see any data from the phase VOLANS study?
22/2 16:27
af Jan Van de Winkel
We are still very committed to broaden our partnership base and are most focused on making available our proprietary technology platforms for direct ownership of products, or options to obtain ownership of products. These are firm priorities for 2018.
22/2 16:26
af Jan Van de Winkel
but missed the milestone because the target was multiple collaborations....
22/2 16:26
af Jan Van de Winkel
Genmab executed a very nice option to license agreement with Novo Nordisk in December 2017....
22/2 16:25
af Sukkeralf
Regarding the Janssen DuoBody collaboration only 2 options remain - how many preclinical programs are still active and do you expect any IND´s in 2018 from this collaboration ?
22/2 16:25
af Jan Van de Winkel
This may well have an impact from here on available capacity. The big step forward is expected to come from availabilty of a new sub Q formulation.
22/2 16:24
af Sukkeralf
Genmab did not enter any new technology collaborations in 2017 (the only goal missed) - could you explain in a bit more detail the strategy going forward (targets, option etc.) because from the outside it seems like a lack of interest (Janssen signing a deal with Zymeworks recently)?
22/2 16:24
af Jan Van de Winkel
The issue discussed was availability of infusion capacity in healthcare centers, it is likely that a 90 min infusion as per data from Ohio State at ASH, is already improving the availability of infusion capacity....
22/2 16:23
af MrEbbe
You mentioned that the explanation on stagnation on the US sales is issues with capacity, what are J&J and Genmab doing to solve this for the future?
22/2 16:23
af Jan Van de Winkel
The CHMP recommends for approval, and approval tends to come 60 days after the CHMP recommendation.
22/2 16:22
af Mcjean
Yesterday D. Eatwell was mention DVMp-approval in august. Isnt it correct that CMHP will discuss it in marts and approve it 2 month after in may? If yes, will that not influence the sale in a positive way, because you get 3 month more sale and maybe influence the guiding for the year? Second will DVMp could be used in US in some way off record?
22/2 16:22
af Jan Van de Winkel
This is a good thought.
22/2 16:21
af E L
In january you started a “Study to evaluate Subcutaneous Daratumumab in combination with Standard Multiple Myeloma Treatment Regimens”, which is a Phase 2. You already have the Phase 3 SC vs IV study; could these 2 clinical trials be the basis for an overall approval of SC in all lines and settings?
22/2 16:21
af Jan Van de Winkel
Right now Rev dex is the key combination in the US, and VMP in Europe.
22/2 16:20
af E L
Do you expect any uptake of Dara-VMP for US patients if approved by the FDA, or in other words, could it change US practice away from Revlimid?
22/2 16:20
af Jan Van de Winkel
There are around 11,000 patients involved in daratumumab studies and the number is rapidly rising as new studies come online.
22/2 16:19
af E L
Do you have an estimate on the number of patients treated with Dara AND the number of patients in clinical trials? Do patients get Dara for free or at cost in clinical trials?
22/2 16:19
af Jan Van de Winkel
Daratumumab has the broadest mechanism of action of all CD38 antibodies. It is unclear which mechanisms play a key role in the immuno modulatory action of CD38 antibodies. Dara has been shown unusually potent in activating the immune system in MM patients. So seems to be highly active which bodes well for its potential in solid tumors.
22/2 16:17
af Solsen
Mr. Winkel. According to KOL from MD Anderson Isatuximab probably has stronger inhibition of the ecto enzymatic activation versus other CD38 antibodies. This might lead to better efficacy in solid cancers. What are your expectation to the competition from Isatuximab in solid cancers. Sanofi has announced a massive investment in solid cancers. We havent seen much to JNJ/Janssens intentions in solid cancers ?
22/2 16:16
af Jan Van de Winkel
We are about to start the two studies, and will update the market on progress over the coming months.
22/2 16:15
af Solsen
Mr Winkel: Have Genmab been dosing the first patients in DR5xDR5 or CD3xCD20. And how quick is the escalation planned ?
22/2 16:15
af Jan Van de Winkel
currently Novartis is focusing MS, but is aware of good data with the sub Q formulation with ofatumumab in RA.
22/2 16:14
af Bulder
GSK terminated a couple of studies with IV ofa in RA, but did complete one safety study with sc ofa. Are there any plans of resuming trials with sc ofa in RA, now that Novartis has taken over?
22/2 16:14
af Jan Van de Winkel
This is mainly an EU regimen, albeit that VMP is also used in Japan as a popular regimen.
22/2 16:13
af Bulder
Do you think that D+Vmp in frontline MM vil be used in the US, as many us-doctors think that melphalan is a bit obsolete? Or could the combination be used in frontline without melphalan? Or maybe with the US-equivalent CyBorD?
22/2 16:12
af Jan Van de Winkel
In principle these could be combinable, with BCMA ADC as a more logical combination partner for dara.
22/2 16:12
af Bulder
Can dara combine with BCMA car-t or other BCMA-targeted therapies (ADC or bispecifics) in MM in the future?
22/2 16:11
af Jan Van de Winkel
We are in the process of finalising the protocols and will communicate once ready.
22/2 16:11
af Bulder
From the R&D-presentation in december we can see that you plan a TV combo in frontline cervical. Which other drug(s)?
22/2 16:10
af Jan Van de Winkel
and are currently working on new frontline combination studies with Janssen in the transplant eligible setting.
22/2 16:10
af Jan Van de Winkel
We already have a Phase 3 study with Krypolis in second line which is actively recruiting....
22/2 16:09
af Bulder
There are a couple of smaller ISS phase 2 studies of D+KRd frontline MM already. When will we see a large Janssen sponsored phase 3 study of D+KRd in the frontline ASCT-eligible setting?
22/2 16:09
af Jan Van de Winkel
and Ocrevus from Roche (a CD20 antibody on the market in MS) shows impressive sales numbers from launch.
22/2 16:08
af Jan Van de Winkel
Novartis already positions Ofatumumab as a candidate blockbuster....
22/2 16:08
af Jan Van de Winkel
the size of the market currently is over 18 bn USD and is expected to grow rapidly over the coming years....
22/2 16:07
af GeorgeBest
How much do you expect peak sales for ofatumumab in MS can reach - if approved? And in which time frame?
22/2 16:05
af Jan Van de Winkel
1 USD - 6.00 DKK
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