Biotech Values

[DewDiligence]

ABBV/Roche present phase-2 Venetoclax* data in second-line CLL with 17p deletion; NDA/MAA submitted:

http://finance.yahoo.com/news/abbvie-reports-phase-2-results-160500524.html

The data show venetoclax monotherapy achieved its primary endpoint with a 79.4 percent (n=85/107) overall response rate (ORR), with 84.7 percent having sustained duration of response (12 month estimate, overall median duration of response was not reached)…. Partial response (PR) was reported in 69.2 percent (n=74) of patients.

Treatment-emergent adverse events (AEs) (all grades) in ≥20 percent of patients were neutropenia (43%), diarrhea (29%), nausea (29%), anemia (27%) and fatigue (22%). Grade 3/4 AEs in ≥10 percent of patients were neutropenia (40%), anemia (18%) and thrombocytopenia (15%).

The sponsors have submitted the data from this Phase 2 study…to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively…

The success of this pivotal trial was announced in August (#msg-116144008), but the details were unveiled today at ASH.

* f/k/a ABT-199.