Phase 2 results of AbbVie’s venetoclax in patients with R/R CLL with 17p deletion published in The Lancet Oncology

May 17 2016

AbbVie, a global biopharmaceutical company, today announced The Lancet Oncology published results from the Phase 2, single arm, open label trial studying venetoclax in patients with relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) with 17p deletion. The data demonstrated venetoclax is active and achieved high overall response rates in addition to rates of complete remission and minimal residual disease negativity (MRD-).

"While the chronic lymphocytic leukaemia treatment landscape has continued to evolve, CLL with 17p deletion remains particularly challenging to treat,” said Stephan Stilgenbauer, M.D., Ulm University, Germany, lead author of The Lancet Oncology paper. “These data reinforce the important role venetoclax could play as a new treatment option for patients battling this chronic blood cancer.”

The data demonstrate venetoclax achieved high response rates, with a 79.4 percent (n=85/107) overall response rate (ORR). Additionally, 10 percent (n=11/107) achieved complete remission (CR) or complete remission with incomplete recovery of blood counts (CRi) and nodular partial remission (nPR). Eight percent (n=8/107) achieved CR or Cri and 3 percent (3/107) achieved nPR. Further, in patients who had either regional or high-quality local results available, MRD- (exploratory objective) was achieved in 18 patients.

“We are pleased to see these data showing venetoclax can achieve high rates of overall response in CLL patient population who generally have a poor prognosis,” said Alice Butler, Medical Director, AbbVie UK. “In CLL patients, specifically those with 17p deletion, new therapy options are needed that can provide complete remission and high overall response rates.”

The Phase 2 data were previously presented at the 57^th Annual American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida in December 2015.

In January 2016, AbbVie announced that the European Medicines Agency (EMA) had validated its MAA for venetoclax for the treatment of patients with CLL with 17p deletion or TP53 mutation. In February 2016, the EMA granted orphan designation to venetoclax for the treatment of AML. Venetoclax is currently under review by the EMA and other health regulatory authorities and is being evaluated in Phase 3 clinical trials for the treatment of R/R CLL, along with earlier phase studies in several other cancers. In the UK, venetoclax has been granted a Promising Innovative Medicine (PIM) designation by the MHRA.