Genmab — November 2020

[E_L]

BioNTech SEC filings GEN1046
; you can choose if you want ot download it or just view it in your browser by clicking html https://investors.biontech.de/sec-filings/sec-filing/6-k/0001564590-20-052594

[E_L]

cut off date Aug31

[E_L]

Data cut-off for Efficacy September 29 I see

[E_L]

Disease control was achieved in 65.6% of patients, including
partial responses in triple-negative breast cancer (n=1), ovarian
cancer (n=1), and ICI-pretreated NSCLC (n=2).

[E_L]

Of six patients with NSCLC, all of whom
had received prior immune checkpoint
inhibitor (ICI) therapy, two achieved
unconfirmed PR, two maintained SD, and
two experienced progressive disease

[E_L]

Expansion cohort
● As of October 12, 2020, 24 patients were enrolled in expansion cohort 1, which includes patients with
NSCLC with progression on or after ICI therapy (Figure 8).
– 12 patients had post-baseline scans; six patients continued treatment with GEN1046, six patients
discontinued.
– Preliminary efficacy in 12 patients who could be objectively assessed showed two patients who
achieved confirmed PR, one with unconfirmed PR, and four patients with SD.

[E_L]

So it seems they start with NSCLC in the expansian cohorts? Note there where only 6 patients in the escalation cohort, they already put 24 in the expansian as of Oct 12

[AaBforever]

Seems that the market down like it.

[AaBforever]

don´t

[Sukkeralf]

So not the 4-1BB week I´d imagined so far - so hard to judge these early data. Looking forward to the explanations on CMD

[E_L]

Well, this early it is all about safety, and longer data hardly changed from what we already saw, so that is a +

[E_L]

●   Most AEs were mild to moderate; treatment-related Grade 3 transaminase elevations resolved with corticosteroids.

–   No treatment-related bilirubin increases or Grade 4 transaminase elevations were observed.

[JørgenVarnæs]

Mon det er de 2 opgørelser med 65,6% SD/PR og ORR=11-33%, der forvirrer begreberne?

[E_L]

i think that is important, if liver toxicity can be handled

[JørgenVarnæs]

Når vi er så langt henne i sygdomsforløbet bliver man nødt til at kigge alvorligt på SD tallene også (IMO)

[E_L]

agree, specially since most of them are not yet on the highest dose

[E_L]

it doesn't say at what dose the NSCLC expansian is, does it?

[JørgenVarnæs]

Men jeg vil ikke lægge alt for meget vægt på orr endnu - dertil er antallet af patienter for småt. Men det er jo gætværk vi er ude i her - så måske med n=30 vi har et solidt fingerpeg

[Bulder]

Ja, umiddelbart falder man jo ikke ned af stolen. Men måske kan man ikke forvente mere af så syge pts.

[Bulder]

Kan godt være at SD i virkeligheden er udmærket.