---
title: "Day One concludes patient enrolment for tovorafenib’s FIREFLY-2 trial"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/286042283.md"
description: "Day One Biopharmaceuticals has completed patient enrolment in the Phase III FIREFLY-2 trial for tovorafenib, aimed at treating paediatric low-grade glioma (pLGG). The trial evaluates tovorafenib's safety and efficacy compared to standard chemotherapy for patients aged 6 months to 25 years. Conducted at 140 sites globally, it has enrolled around 400 participants. The primary endpoint is overall response rate, with preliminary results expected in 2027. Day One aims to establish tovorafenib as a new standard of care for BRAF-altered pLGG patients."
datetime: "2026-05-11T09:39:26.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/286042283.md)
  - [en](https://longbridge.com/en/news/286042283.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/286042283.md)
generator: "portal-rs"
---

# Day One concludes patient enrolment for tovorafenib’s FIREFLY-2 trial

The trial will explore the oral tovorafenib monotherapy for patients with RAF-altered pLGG who require initial systemic therapy. Credit: TheCorgi / Shutterstock.com.

Day One Biopharmaceuticals has concluded patient enrolment in the Phase III FIREFLY-2 trial assessing tovorafenib for paediatric low-grade glioma (pLGG).

The randomised, global, open-label, multi-centre trial is evaluating the safety, efficacy, and tolerability of tovorafenib, compared to standard of care chemotherapy, as a first-line therapy for patients aged six months to 25 years with low-grade glioma.

It is a collaborative effort involving the European Society for Paediatric Oncology (SIOPe) Brain Tumor Group LOGGIC Consortium.

Also called Ojemda, tovorafenib is currently approved for treating patients six months and older with relapsed or refractory pLGG with b-raf proto-oncogene, serine/threonine kinase (BRAF) fusion, rearrangement, or V600 mutation.

The trial will explore oral tovorafenib monotherapy for patients with RAF-altered pLGG who require initial systemic therapy.

It is being carried out at 140 sites across Australia, Asia, Canada, Europe, the Middle East, South America, and the US.

In more than three years, the study has enrolled around 400 participants, randomising them to receive either tovorafenib weekly or one of four standard chemotherapy regimens.

The primary endpoint is overall response rate, including duration of response per Response Assessment in Paediatric Neuro-Oncology Low-Grade Glioma (RAPNO-LGG) criteria.

Key secondary endpoints comprise progression-free survival, event-free survival, time to next treatment, overall survival, and patient-reported outcomes.

Preliminary insights from the Phase III trial are anticipated to be available in 2027.

Day One chief medical officer Elly Barry said: “Reaching full enrolment in this trial is a critical step toward our goal of establishing Ojemda as standard of care across all lines of therapy for individuals with BRAF-altered pLGG. By moving earlier in the treatment journey, we aim to intervene when we can have the greatest impact on the burden of this challenging cancer.

“Success in this study would not only further validate the efficacy and safety profile of Ojemda, but also fundamentally evolve the pLGG treatment paradigm, and potentially establish a new standard of care for patients newly diagnosed with pLGG, the most common brain tumour afflicting children.”

### Related Stocks

- [DAWN.US](https://longbridge.com/en/quote/DAWN.US.md)

## Related News & Research

- [SciSparc subsidiary NeuroThera Labs enrolls 26 children in SCI-210 autism trial](https://longbridge.com/en/news/297556067.md)
- [07:30 ETPorkRinds.com's 'Crunch Time Hero® of the Week' Returns to Support Pediatric Brain Cancer](https://longbridge.com/en/news/297177332.md)
- [15:05 ETStarlight Children's Foundation Launches "Stream For Starlight" Campaign in Honor of Childhood Cancer Awareness Month](https://longbridge.com/en/news/297688562.md)
- [IDEAYA targets year-end 2026 start for Phase 3 IDE849 trial in extensive-stage small cell lung cancer](https://longbridge.com/en/news/297497016.md)
- [08:51 ETBaltimore Children & Youth Fund Announces 2026 Grant Slate, Awarding Nearly $4.76 Million in Grants Serving Youth Across the City](https://longbridge.com/en/news/297789389.md)

---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**