Fig. 1: FIREFLY-1 patient disposition/CONSORT diagram.

This report presents efficacy data from the evaluable population (enrolled patients who received at least one dose of tovorafenib and met the prespecified efficacy analysis criteria per each radiological assessment method according to the IRC) in arm 1 (registrational) and the safety data from arms 1 and 2 (safety analysis set) as of a 5 June 2023 datacut. Patients were enrolled in arm 2 (extension) after arm 1 had fully accrued and closed for enrollment. aNot radiologically confirmed. bOnly patients with measurable disease at baseline per independent review were included.