Rod Humerickhouse, MD, PhD, asset strategy leader at AbbVie discusses some of the Venclexta (Venetoclax) data presented at this year’s 60th American Society of Hematology’s 2018 annual meeting in San Diego. Venclexta, combined with Vidaza, Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.
Venclexta received accelerated Food and Drug Administration approval last month for patients aged 75 and older – combined with Vidaza or low-dose cytarabine, also known as LDAC – or ineligible for intensive induction chemotherapy. The approval was based on earlier data from the same studies presented at the ASH meeting. The had initially received accelerated approval in 2016 for chronic lymphocytic leukemia in patients with a mutation known as 17p deletion and is now approved for patients with CLL and small lymphocytic lymphoma – or SLL, a closely related disease – regardless of 17p status.
The new AML data position the drug – especially combined with hypomethylating agents – as standard of care among elderly and unfit patients in the upfront setting. In the 115-patient Phase Ib hypomethylating agent study, 67% of patients who received Venclexta with Vidaza achieved a complete remission with at least a partial blood count recovery, known as a CR/CRh rate. The CR/CRh rate was 71% for those who received Venclexta and Dacogen. Among the 82 patients receiving the drug with LDAC in that Phase I/II trial, the rate of complete remission with or without full recovery of normal blood counts – also known as CR/CRi – was 54%. The median duration of remission in the LDAC study was 8.1 months, according to Roche’s announcement. For the Vidaza and Dacogen arms, Pollyea said the durations of remission were 21 and 15 months, respectively. No unexpected adverse events were observed in any of the three combinations.