Genmab — Maj 2021

[Sukkeralf]

Or it could be adverse effects - was it in ovarian cancer they were more affraid of bleeding?

[E_L]

possible. shame it didn't come a day earlier, we could have asked Jan

[Bulder]

send a mail to IR?

[Sukkeralf]

Done

[E_L]

ok, curious if they will answer that

[E_L]

Both CHRYSALIS/Amivantamab and the GEN1042 trials had their Estimated Primary Completion Date extended https://clinicaltrials.gov/ct2/history/NCT02609776?A=54&B=55&C=merged#StudyPageTop .https://clinicaltrials.gov/ct2/history/NCT04083599?A=3&B=4&C=merged#StudyPageTop which is a similar situation where i wonder if that is a good or a bad thing

[Bulder]

In this case primary completion and completion is not changed, so they are probably not stopping the trial.

[Sukkeralf]

Andrew skriver SeaGen styrer dette studie, så ikke meget held der !

[Sukkeralf]

Andrew writes that it is SeaGen that runs this study - so no luck there

[Sukkeralf]

Such impressive deals on preclinical programs:

[Sukkeralf]

Just a moment...

(www.firstwordpharma.com)

[martinicph]

Man kunne skrive til, [email protected]. Måske de svarer lige så hurtigt som Andrew.

[troldmanden]

Når et studie standses så tidligt før tid så er det hvis mere reglen end undtagelsen det er dårligt nyt. Så vi skal ud i undtagelsen her hvis det er.... Der bør relativt hurtigt komme meddelelse med begrundelse

[deleted-user]

Er studiet ikke forsat aktivt og rekruttering stoppet?

[Sukkeralf]

Jo - så helt galt er det ikke

[Bulder]

Hvis der var alvorlige AE ville de jo ikke fortsætte med at behandle dem, der er rekrutteret.

[Bulder]

Det er nok snarere på effektsiden at hunden ligger begravet.

[Sukkeralf]

Or maybe just at stop of recruitment until this have been decided:

[Sukkeralf]

The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisot

[Sukkeralf]

tumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.