maxen schreef op 8 januari 2019 09:44:
[...]
Heb zelf een transcript gemaakt van het stuk startend vanaf 21.00:
21.09 JP Morgan Vragensteller:
“And then, on On the filgotinib front, you already mentioned that you have two phase III readouts on RA. At this point, how derisked you believe these trials are, following the first data you announced in the fall, and then can you also remind us of the filing timelines here giving the standing of the testicular safety study, the Manta trial?”
21.30: Answer Gilead CSO McHutchison:
“So, the first study that read out last year was in the most difficult to treat group of people, biologically non-responders
(Finch 2 – Maxen). Fantastic efficacy, even if you had received three or more prior biologics, the ACR20 read is still 70-odd procent, which is fantastic data. So, I think that is likely to reach through to the easier groups of treated patients, so methotrexate inadequate responders
(Finch 1 – Maxen) and methotrexate naive patients
(Finch 3 – Maxen). So these next few trials that are reading out this quarter are an additional 2800 patients.
So I think efficacy-wise we are derisked as much as you can be with … good data in the most difficult to treat group of patients.
We need more safety data. There is only 400 patients in that initial trial and we will have another 2800 patients so we will have to look at this differentiated safety profile that we believe we see already in … play with hemoglobin and soforth.
And in terms of filing: We have to collect the data of the three phase 3 programs. We will probably be filing in other parts of the world
(non-usa dus, maxen) without the data of the male safety study (it is not a requirement), and then our filing in the US will be after we have more data of the Manta study, (that is) how it is called, or the male safety study...
JP Morgan Vragensteller: "OK, ..."
Gilead CSO McHutchison nog snel:
"Things to be determined" (
of "That’s to be determined" ?-
Maxen).
Maxen:
Ze zijn dus erg blij met de Finch 2 data. M.i. verder geen nieuws.
De werking van filgotinib is eigenlijk al wel bewezen met de moeilijkste groep uit Finch 2. Voor de veiligheid is meer data nodig om echt te bewijzen dat filgotinib zich daarin onderscheidt van de andere JAKs, zoals met hemoglobin en andere zaken het geval lijkt te zijn
Geen nieuws over Manta. Bij een eerdere discussie (weet even niet meer welke, ergens in Q4) filosofeerde McHutchison nog veel verder door over Manta. Over de mogelijkheden om in de US filgotinib alvast te filen, en pas later de Manta data in te sturen. En over de continue discussies (intern en met de US instanties) om de toelatingseisen voor Manta te verbreden, door bv andere indicaties toe te laten, dacht ik. Nu niets van dat al, maar slechts:
"and then our filing in the US will be after we have more data of the Manta study", en
"Things /that's to be determined".