Genmab — Oktober 2019

E_L

it was on the agenda and it went through PRAC earlier this month, so don't know why it didnt get recommended. Unfortunately it takes a few months before we will see the full minutes of the meeting...

Bulder

We've seen that before, that even if it's on the agenda, they don't nescesssarily reach a conclusion.

Bulder

There was no negative opinion either, so next time.

E_L

no , you are correct, there wasn't. hopefully next month then.

E_L

i think they stopped recruiting Cassiopeia summer last year already, so i bet there are a lot of transplant eligible patients waiting to get on this
...

Bulder

I wonder if they are considering a limitation of the indication. We have this problem with Cassiopeia as well as Griffin, that high risk pts don't really benefit from adding dara. In Cassiopeia they do benefit a little, but that is because VTd is a "weaker" combination. In Griffin HR-pts don't benefit at all, as VRd is a better combination. So for 15% of pts it would be waste of money to add dara.

Bulder

That said, it's still early days with Griffin. It could be better over time. And Griffin is only a small study. Perseus will show us how things really are concerning HR pts.

E_L

Are you suggesting JNJ would put a limitation? I doubt they'll do that.... But I agree MD's will be less likely to choose it for HR patients

Bulder

Voorhees himself has spoken about it. Be cautious with HR, if you start to use D-VRd now already. No not JnJ. The authorities.

E_L

do you think there is enough sub-data for them to do that already?

Bulder

For standard-risk, yes. Or what do You mean?

E_L

i was thinking if there were enough patients in that subgroup HR to make that conclusion, but there are i think, just checked https://multiplemyelomahub.com/medical-information/imw-2019-subgroup-analysis-cassiopeia

E_L

the press release from Janssen https://www.businesswire.com/news/home/20191018005289/en/CHMP-Grants-Positive-Opinion-Expanded-Janssen’s-Darzalex▼

Bulder

And in Griffin as well: Dr. Voorhees noted that D-RVd was favored across all subgroups for MRD negativity and stringent compete response, except among patients with high-risk cytogenetics and stage III disease. https://www.mdedge.com/hematology-oncology/article/208465/multiple-myeloma/combo-could-be-new-standard-transplant-eligible