Genmab — Oktober 2018

[concillado]

(just kidding)

[E_L]

Bryan Garnier
Victor Floc’h
05/10/2018
Genmab | It’s Time to GEN up on ofa!
Following J&J's decision to discontinue two clinical trials evaluating Darzalex with I/O therapies in lung cancer and multiple myeloma last May, Genmab shares dropped 20% and have yet to recover. In our view, the market is overly conservative and does not fully value either Darzalex or ofatumumab.

[E_L]

does any of you have that report?

[bibob]

$name

(danskebank.dk)

[JKY_VH]

Tak bibob

[E_L]

New trial: A Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma https://clinicaltrials.gov/ct2/show/NCT03697629?term=daratumumab+OR+ofatumumab+OR+tisotumab&lupd_s=10%2F05%2F2018&rank=1

[E_L]

To determine infusion related reactions in the first 6 months of daratumumab administration. Using 90min schedule.

[E_L]

and they are being cheap lol: Following the 6 monthsubjects who continue to have a response to daratumumab will be taken off study..., ..., but dara can be supplied outside of the clinical trial setting.

[E_L]

New trial: Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma (PREDATOR) https://clinicaltrials.gov/ct2/show/NCT03697655?term=daratumumab+OR+ofatumumab+OR+tisotumab&lupd_s=10%2F05%2F2018&rank=2

[E_L]

not sure I understand what they mean with biochemical or preclinical relapse? Anyone else?

[Solsen]

@Gentogen - Er det ikke et forudbestemt
antal events der bestemmer en interim analysis ?

[Solsen]

Altså uanset hvilken arm de kommer fra.

[dohk]

I believe biochemical relapse is M-protein detection etc and MDR relapses is established by DNA sequencing of MM clone cells. So essential protein versus DNA methods to establish relapse.

[dohk]

I would suspect that MRD relapse happens before you can measure M-protein spike, so MRD will properly be a new gold standard in the future.

[Bulder]

One of the differences between the new Canadian study and Ohio State's accelerated study, is that in the Canadian study pts get 1½ hour infusion from day one.

[Bulder]

sorry 4 hours day one

[Bulder]

and only half dose. Kind of premedication.

[gentogen]

Solsen 15:44. Jo, der er vist det mest almindelige, men jeg læste et eller andet sted, at nogle metoder kræver et mindste antal i hver arm til forskel fra en total sum

[gentogen]

I det hele taget er interim analyse lidt af en videnskab i forhold til sikkerheden af statistikken...

[Solsen]

Statistik er ikke for amatører - thats for sure !