AbbVie Reports Phase 2 Results of Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia Patients with 17p Deletion, Achived Primary Endpoint With 79.4% ORR

AbbVie ABBV, a global biopharmaceutical company, today announced results of a Phase 2, open label trial studying investigational compound venetoclax in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and 17p deletion. In the trial, some patients were shown to respond to treatment, including complete remission (CR) and minimal residual disease negativity (MRD-).1 The results from this trial, which was sponsored by AbbVie in collaboration with Genentech and Roche, were presented today during the 57th American Society of Hematology Annual Meeting (ASH) in Orlando, Florida. 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 (FDA) 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 responses to monotherapy treatment with venetoclax are encouraging in these patients, who are among the most challenging to treat because they have CLL with 17p deletion," said Stephan Stilgenbauer, M.D., Ulm University, Germany, lead author on the study. "These results are consistent with the overall response rates observed in earlier studies, validating our research of venetoclax in relapsed/refractory CLL patients including those with the 17p deletion." 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 (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%). "We are very encouraged by these results showing that venetoclax can achieve high rates of overall response in a difficult-to-treat patient population with relapsed/refractory CLL, such as those with 17p deletion," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "These encouraging results are part of our regulatory submission to the FDA and we are committed to working with FDA and EMA to deliver this treatment to appropriate patients."