Ideaya Biosciences (IDYA) said Monday it has successfully completed a Type D meeting with the US Food and Drug Administration on the design of a phase 3 registrational trial to evaluate the safety and efficacy of its darovasertib precision oncology candidate to treat primary uveal melanoma.
The trial is expected to start in H1 and will use eye preservation and the proportion of patients with vision loss as its primary endpoints and with no detriment to event-free-survival as a secondary endpoint for both cohorts, the oncology company said.
Other secondary endpoints will include overall response rate, the proportion of patients with clinically significant macular edema and the proportion of subjects with legal blindness.
Shares were almost 6% higher in recent premarket activity.
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