Curis’ Phase I/IIa TakeAim Leukemia clinical trial of emavusertib (CA-4948) for acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS) was placed on a partial clinical hold by the US Food and Drug Administration (FDA).
With the latest development, the regulatory agency has sought further data from the trial, including those linked to the death of a subject with relapsed or refractory (R/R) AML.
The trial will not enrol new participants while the presently enrolled subjects who benefit from the therapy could continue to receive 300mg twice daily or lower doses of emavusertib. Emavusertib is an inhibitor of IRAK4 kinase.
The open-label, single-arm dose escalation and expansion trial is designed to assess the oral dose of emavusertib as a single agent and along with azacitidine or venetoclax in R/R AML or high-risk MDS patients.
Curis noted that the patient under question had various conditions, including rhabdomyolysis, which was earlier classified as emavusertib’s dose-limiting toxicity.
Furthermore, the FDA is seeking safety, efficacy and other findings, including data linked to rhabdomyolysis and the identification of the recommended Phase II dose of emavusertib in the trial.
On FDA lifting the partial clinical hold and the linked impact on the study is evaluated, Curis anticipates to provide the updated guidance on the timing of talks with the regulatory authority to seek registration for emavusertib.
Curis CEO James Dentzer said: “We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives.
“Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review.”
The latest move will not impact another open-label, dose-escalating Phase I/II TakeAim Lymphoma study but Curis will halt new subject enrolment in this trial.
The TakeAim Lymphoma study is assessing emavusertib in people with B-cell malignancies.
In February last year, Curis dosed the first subject in Phase I trial of CA-4948 plus ibrutinib in individuals with R/R hematologic malignancies.