Syros starts study to drive IV to oral switch in leukemia

cancer newspaper
Syros will use an early-phase study to identify the optimal dose to take into phase 3 next year. (PDPics/Pixabay)

Syros Pharmaceuticals is racing forward with its effort to develop an oral leukemia treatment, dosing the first patient in an early-phase study to lay the groundwork for a planned move into phase 3 next year.

Treatment of the targeted disease, acute promyelocytic leukemia (APL), has been transformed by the development of a regimen based on arsenic trioxide in recent years. The regimen has a cure rate of around 80% but requires patients to undergo up to 140 two- to four-hour infusions across almost one year, creating opportunities to reduce burdens, boost access and cut healthcare costs. 

Syros moved to seize those opportunities last year by acquiring an oral arsenic drug candidate from Orsenix. By tapping Bain Capital Life Sciences for cash around the same time, Syros embarked on a path that could lead to a filing for approval of the oral candidate, SY-2101, in 2024.

This week, Syros took an early step on that path by administering SY-2101 to the first patient in a dose-confirmation study. Syros will use the study to identify the optimal dose to take into phase 3 next year.

RELATED: Syros targets KRAS-mutant cancer with CDK7 inhibitor

“We believe SY-2101 could quickly become the new standard of care for APL by offering patients similar efficacy with a substantially more accessible and convenient therapy. We plan to move swiftly from our dose confirmation study into a phase 3 trial next year, with the goal of filing a new drug application in 2024,” David Roth, M.D., chief medical officer at Syros, said in a statement.

Other groups have already delivered long-term clinical data on the effects of oral arsenic, but Teva’s intravenous formulation Trisenox remains the treatment option for APL patients in the U.S.