Genmab — Oktober 2019

[Sukkeralf]

Godt nok skuffende hvis det ender med at isatuximab får et gennembrud i solide før daratumumab

[Solsen]

Jo lidt underligt, at JNJ ikke kommer efter solide. Men er der ikke noget med de selv har en PD-1 under udvikling og måske vil afvente den.

[Solsen]

Jeg ser stadig ikke de kan hente dara i MM. De har på ingen måde bevist de er bedre, hvorfor de får meget svært ved at fortrænge dara.

[Bulder]

Der kan være lidt her: However, one particular difference is that unlike Darzalex, it is not associated with complement activation, meaning it can be more readily given to patients with asthma or chronic obstructive pulmonary disease.
“It’s not a trivial population,” said Dr. Paul Richardson. https://medcitynews.com/2019/06/sanofis-isatuximab-shines-in-myeloma-at-asco-but-where-will-it-fit-into-treatment/?rf=1

[peter12]

Der kører da forsøg med dara i solide ? https://www.clinicaltrials.gov/ct2/show/NCT03098550?term=daratumumab+solid&rank=2

[Solsen]

Jo da men det er et BMS forsøg. Så ikke megen aktivitet fra JNJs side.

[Solsen]

Cetrelimab hedder JNJ PD1 https://clinicaltrials.gov/ct2/show/NCT02908906

[Sukkeralf]

Solsen tror absolut heller ikke isatuximab vil erstatte daratumumab, men der kommer trods alt en del Mm drugs på makredet - og hvis enkelte af dem nupper en halv til hel milliard dollars af omsætningen, så kan det være peaksale måske ender 1-3 milliarder dollars lavere i MM

[Sukkeralf]

isatuximab kan eksempelvis begynde at spille på pris, men der er stadig lang vej til de er repræsenteret så bredt som daratumumab er.

[GeorgeBest]

de 1-3 milliarder USD kan amyloidosis så passende kompensere for...

[E_L]

My understanding from the last JNJ R&D day was that they would wait with solid until the SC approval

[E_L]

Lebowitz said that in that earlier lung trial the concern was that steroids are taking away from the immune response. He adds: we have developped (and into the clinic) a steroid sparing regimen where we can get the streroids off -and we needed the SC to do that

[E_L]

And once we have those pieces in place I think we retest that hypothesis on immunomodulatory properties of darzalex

[E_L]

https://edge.media-server.com/mmc/p/jjsewqjm 4:33:30

[Sukkeralf]

Jan said earlier that they also needed approval of sc dara in MM first - they didnt want to jepardizy that with deaths in solids I guess

[E_L]

i remember you writing that exact sentence before

[Bulder]

Mht BMS-studierne i solide - dara-nivo - er der ikke meget tilbage. Der var vist 3. Det ene er lukket for rekruttering https://www.clinicaltrials.gov/ct2/show/NCT03098550?term=daratumumab+nivolumab&rank=2 Det andet er lukket i dara cohorten https://www.clinicaltrials.gov/ct2/show/NCT02488759?term=daratumumab+nivolumab&rank=4

[E_L]

So it has been 1 of the other reasons i thought SC approval is so important; it could mean the start of new trials imho...

[E_L]

then again, who knows now what HexaBody-CD38 will bring? We can assume that it is either more potent of safer -or both , if they go through with it, so maybe a more obvious partner for solid combinations...

[Bulder]

Tilbage er der kun checkmate 142, som også er lukket for rekruttering, men det kan være fordi de er ved at være færdige. https://www.clinicaltrials.gov/ct2/show/NCT02060188?term=daratumumab+nivolumab&rank=5