Lucia Masarova, MD, Discusses EXCEED-ET Trial Design, Enrollment Process

Lucia Masarova, MD, of the University of Texas MD Anderson Cancer Center, discusses her 2023 American Society of Clinical Oncology Annual Meeting presentation on the EXCEED-ET trial, which is currently enrolling patients.

The single-arm multicenter study is designed to evaluate the efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft in North American adults with essential thrombocythemia.

The study involves a 28-day screening period, a 12-month treatment phase, and a 28-day follow-up period, for a total trial duration of 14 months.

Its primary endpoint is a durable response, which is defined as the proportion of subjects who achieve simultaneous peripheral blood count remission for at least 80% of biweekly measurements consecutively between weeks 32-52, a durable resolution of disease-related symptoms according to the MPN Symptom Assessment Form Total Symptom Score, and absence of bleeding or thrombotic events.

“Those are very exciting endpoints,” Dr. Masarvoa said, noting that she hopes the trial will “define how we look at the disease in terms of what we can achieve.”