ENESTnext Trial: Evaluating Molecular Response With Front-Line Nilotinib in CML
Posted: Wednesday, April 17, 2019
Findings from the ENESTnext study presented in Leukemia & Lymphoma further substantiate the molecular response rates associated with front-line nilotinib therapy in patients with chronic myeloid leukemia in chronic phase (CML-CP). The findings demonstrate the feasibility of monitoring very low BCR-ABL1 transcript levels using digital polymerase chain reaction, concluded Jesus G. Berdeja, MD, Director of Myeloma Research at the Sarah Cannon Research Institute, Nashville, and colleagues.
“Early nilotinib therapy is associated with more rapid [deep molecular response], which impacts longer-term clinical outcomes, offset by a modest and well-described safety profile,” the authors observed. “Additionally, deeper molecular responses may enable more patients to be eligible for [treatment-free remission], especially in light of the addition of [treatment-free remission] to the U.S. Food and Drug Administration–approved prescribing information for nilotinib.”
The single-arm multicenter trial evaluated the rate of deep molecular response over 2 years for 128 patients with newly diagnosed CML-CP. Patients were treated with 300 mg of nilotinib twice daily.
After 2 years, 94 patients (73%) achieved a major molecular response (BCR-ABL1 ≤ 0.1% on the International Scale), and 34 patients (27%) achieved a confirmed molecular response 4.5 (BCR ABL1 on the International Scale ≤ 0.0032% detectable or undetectable). Digital polymerase chain reaction detected BCR-ABL1 in 39.4% of samples from patients with a confirmed molecular response 4.5 and identified further decreases in BCR-ABL1 with continued nilotinib.
Researchers found that safety results, including cardiovascular events, were consistent with those in other nilotinib trials. The most common grade 3 or 4 adverse events were increased lipase (12.5%), thrombocytopenia (8.6%), and neutropenia (6.3%).
Disclosure: The study authors’ disclosure information may be found at tandfonline.com.