Benzinga | May 20, 2021 06:03AM EDT

Positive Primary Analysis From The Phase 2 OPTIC Study of Ponatinib in Chronic Phase-Chronic Myeloid Leukemia To Be Presented at the 2021 ASCO Annual Meeting

Incyte (NASDAQ:INCY) today announced that data from the primary analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session (Abstract #7000) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually June 4-8, 2021. The OPTIC trial -- an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ponatinib (Iclusig(r)) over a range of three starting doses (45mg, 30mg, 15mg) followed by dose reduction to 15mg with the aim of optimizing efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant to prior tyrosine kinase inhibitor (TKI) therapy -- met its primary endpoint.

The trial, sponsored by Takeda and co-funded by Incyte, evaluated treatment in patients with resistant disease, with and without mutations. The results show that the optimal benefit-risk profile for ponatinib in patients with CP-CML was achieved with a starting dose of 45mg/day, and upon response (achieving ?1% BCR-ABL1IS), dose reduction to 15mg/day. The results also suggest a clinically-manageable safety profile for ponatinib. Data from the OPTIC interim analysis (cutoff date of July 2019), which evaluated 216 patients with a median follow-up of 21 months, were previously reported. The primary analysis (cutoff date of May 2020) evaluated 283 patients with a median follow-up of 32 months. All patients in the OPTIC trial were evaluable for the primary endpoint at the time of this analysis.