Genmab — Juni 2017

[Bulder]

Kite får PR for sin CD19 CAR-T i R/R NHL http://www.targetedonc.com/news/ktec19-granted-priority-review-by-fda-for-nonhodgkin-lymphoma

[royal]

Sorry, Celgene

[JohnW]

Kan vi mon stadig forvente at få svar fra FDA i dag/i aften?

[Sukkeralf]

royal - nope ! this one:

[Sukkeralf]

ClinicalTrials.gov

(clinicaltrials.gov)

[Sukkeralf]

i dag eller mandag - en sjælden gang imellem går de et par dage over

[royal]

Thank you

[flottenschmecker]

Den her pdufa gør vist markedet lidt nervøst - volumen er helt væk

[JohnW]

Vi kan nok godt vente nogle dage endnu...når blot det er godt nyt

[royal]

Timer.....

[KWC]

Preliminary data shows responses achieved in 11 of 34 evaluable patients with cervical cancer treated with tisotumab vedotin
Next steps in clinical development of tisotumab vedotin in this indication under active consideration

[KWC]

Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study

[KWC]

"The preliminary data we see in patients with cervical cancer treated with tisotumab vedotin are encouraging. We believe further development of this novel antibody-drug conjugate may be warranted in cervical cancer and are actively looking into possible next steps," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

[KWC]

Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjuga

[JKY_VH]

tak KWC

[KWC]

conjugates (ADC), including peripheral neuropathy and neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin specific toxicity, which led to introducing of prophylactic management. In the cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse events: gastro-intestinal related (5 patients), anemia (2 patients), infections (1 patient), neuropathy (2 patients), bleeding (2 patients), other (10 patients).

[KWC]

Genmab is considering plans for further clinical development of tisotumab vedotin in cervical cancer. The GEN701 study is ongoing and further data in both cervical cancer and other solid tumor indications will be published at a later date.

[KWC]

Genmab intends to submit data from this study for presentation at an upcoming medical conference.

[flottenschmecker]

waaaad!? - nye kliniske data fra GEN!

[flottenschmecker]

mon det er trigger til at SGEN skal bestemme sig?