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FDA lifts clinical hold on trials of vadastuximab talirine for AML
The FDA lifted the clinical hold placed on phase 1 trials designed to evaluate vadastuximab talirine for treatment of acute myeloid leukemia, according to the agent’s manufacturer.
Vadastuximab talirine (SGN-CD33A, Seattle Genetics) is a novel investigational antibody–drug conjugate that targets CD33, which is expressed on most AML cells.
The clinical hold — imposed due to concerns about potential hepatotoxicity — was resolved after a comprehensive analysis of clinical data from 300 patients with AML who were treated with vadastuximab talirine, an evaluation by an independent committee of clinical experts and protocol amendments “designed to further enhance patient safety,” Jonathan Drachman, MD, chief medical officer and executive vice president of research and development at Seattle Genetics, said in a company-issued press release.
Additional risk-mitigation measures will include stopping rules for veno-occlusive disease, as well as revised eligibility criteria, according to the press release.
The company will resume two phase 1 trials. One will evaluate vadastuximab talirine plus standard of care 7+3 chemotherapy in younger patients with newly diagnosed AML. The other will evaluate vadastuximab talirine as monotherapy or in combination with hypomethylating agents in patients with newly diagnosed or relapsed AML.
A randomized phase 2 trial, scheduled to start later this year, will evaluate vadastuximab talirine plus 7+3 chemotherapy as frontline treatment for younger patients with AML.
Enrollment also is continuing for the randomized, phase 3 CASCADE trial, which includes older patients with AML, and a phase 1/phase 2 trial of patients with high-risk myelodysplastic syndrome.
Seattle Genetics will not resume a phase 1/phase 2 trial intended to evaluate vadastuximab talirine monotherapy in pre- and postallogeneic transplant AML.