An independent Data Monitoring Committee recommended terminating the study for futility, concluding results are unlikely to show a statistically significant increase in overall survival. Astellas has stopped enrollment in the trial and is reviewing the results for other action as needed.
'Although we are disappointed by the primary outcome of LACEWING, we are conducting a thorough review of the data and plan to share detailed results at a later date,' said
AML, a cancer of the blood and bone marrow, is one of the most common types of leukemia in adults.1 It has the lowest survival rate of all types of leukemia.2 Approximately one-third of people with AML have a FLT3 mutation.3,4 This mutation is associated with worsened disease-free survival and overall survival, and a higher risk of getting the disease more than once.3,4,5 Among patients with FLT3mut+ AML, an estimated 30-40 percent are not candidates for intensive chemotherapy regimens because of age, performance status, and/or comorbid conditions.6
About the LACEWING trial
The Phase 3 LACEWING trial (NCT02752035) is an open-label, multicenter, randomized trial designed to evaluate gilteritinib plus azacitidine versus azacitidine alone in approximately 250 newly diagnosed FLT3mut+ AML patients who are ineligible for first-line intensive induction chemotherapy. The primary endpoint is overall survival defined as the time from the date of randomization until the date of death from any cause. Key secondary endpoints include event-free survival (EFS), best response, complete remission, composite complete remission and complete remission with partial hematologic recovery.
About Gilteritinib
Gilteritinib was discovered through a research collaboration with
About Astellas
About Astellas
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contact:
Tel: +1-847-224-3014
Email: chris.goldrick@astellas.com
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