DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Approximately 400 treatment-naïve LGG participants will be randomized 1:1 to either

tovorafenib (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2).

Arm 1 (tovorafenib): Treatment cycles will repeat every 28 days in the absence of disease

progression. Participants will continue tovorafenib until any of the following occurs:

disease progression, unacceptable toxicity, withdrawal of consent to treatment, or end of

study.

Arm 2 (Investigator's Choice of SoC Chemotherapy): Participants will receive one of 4 SoC

chemotherapy options selected by the treating Investigator: Children's Oncology Group -

Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology

- Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, vinblastine (VBL)

regimen, or monthly carboplatin. The choice of SoC chemotherapy regimen will be selected

prior to participant randomization. Treatment will continue until completion of therapy

or until any of the following occurs: disease progression, unacceptable toxicity,

withdrawal of consent to treatment, or end of study.

Participants who discontinue treatment due to disease progression will have (1)

radiographic evidence of disease progression, as determined by the Investigator, or (2)

clinical progression, as determined by the Investigator. Investigators are encouraged to

discuss cases of clinical progression and early radiographic progression without clinical

symptoms with the Sponsor Medical Monitor prior to treatment discontinuation or

initiation of a different form of treatment for the malignancy. Participants may continue

therapy beyond progressive disease (PD).