AbbVie Reports Results Of Venetoclax In R/R CLL Patients With 17p Deletion

(RTTNews) - AbbVie (ABBV) announced results of a Phase 2, open label trial studying investigational compound venetoclax in patients with relapsed/refractory or R/R chronic lymphocytic leukemia or CLL and 17p deletion. In the trial, some patients were shown to respond to treatment, including complete remission or CR and minimal residual disease negativity or MRD-. The results from the trial was sponsored by AbbVie in collaboration with Genentech and Roche.

The sponsors have submitted the data from this Phase 2 study of venetoclax, an investigational oral B-Cell Lymphoma-2 (BCL-2) inhibitor, to the U.S. Food and Drug Administration and European Medicines Agency (EMA) as part of a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively, in patients with relapsed/refractory CLL.

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). In an exploratory endpoint assessing minimal residual disease negativity (MRD-) in 45 patients, MRD- of the peripheral blood was observed in 18 patients. More than 10 percent (10.3%) of all patients achieved independently assessed complete or partial response (at 12 months): 7.5 percent (n=8) complete response (CR) or CR with incomplete marrow recovery (CRi) and 2.8 percent (n=3) nodular partial response (nPR).

Partial response 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%).