an attending physician and director of clinical research

 in the department of Neuro-Oncology at Children's Hospital of Philadelphia. 

, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, 

 covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Cassie Kline, MD, MAS, about updated efficacy data from the phase 2 FIREFLY-1 study (NCT04775485) of tovorafenib (Ojemda) in patients with relapsed/refractory pediatric low-grade glioma (pLGG) that were presented at the 2025 Society of Neuro-Oncology Annual Meeting. Dr Kline is an attending physician and director of Clinical Research in the Department of Neuro-Oncology at Children's Hospital of Philadelphia in Pennsylvania.

In our exclusive interview, Dr Kline discussed longer-term efficacy and safety data from the trial, noting the sustained response rates, continued tumor shrinkage, and rates of patients who remained treatment free after approximately 36 months of follow-up.

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Podcasts

Dr Kline discusses longer-term efficacy data from the FIREFLY-1 study of tovorafenib in patients with relapsed/refractory pediatric low-grade glioma.

Tovorafenib Yields Long-Term Efficacy in Pediatric Low-Grade Glioma: With Cassie Kline, MD, MAS

Dr Kline on Updated Efficacy Data With Tovorafenib in R/R Pediatric Low Grade Glioma

"The time to next treatment being over 40 months for our patient population, ideally, is giving our patients and families this nice long period of not necessarily needing additional therapies."

Cassie Kline, MD, MAS, an attending physician and director of clinical research in the Department of Neuro-Oncology at the Children's Hospital of Philadelphia, shared updated results from the ongoing phase 2 FIREFLY-1 study (NCT04775485) evaluating tovorafenib (Ojemda) in relapsed/refractory pediatric low-grade glioma (pLGG).

supported the FDA approval of tovorafenib

-altered pLGG in April 2024. The updated data, encompassing approximately 36 months of follow-up, were presented at the 

The results demonstrated that tovorafenib induced durable responses in patients with recurrent 

-altered pLGG. Updated data showed that evaluable patients (n = 76) achieved an overall response rate (ORR) of 53%, including a partial response rate of 39% and a minor response rate of 13%. The median duration of response was 19.4 months (95% CI, 13.8-27.2), and the median time to response was 5.4 months (95% CI, 1.6-17.5). Kline highlighted that the updated data identified a very long period of time to next treatment, which was 42.6 months (95% CI, 36.7-not evaluable). 

However, the study also confirmed favorable treatment completion and treatment-free intervals, she said. The majority of patients (58%) were able to finish at least 26 cycles of therapy, and most who stopped treatment after completing 26 cycles were able to remain treatment-free for up to a year. This long interval could offer patients and families a significant period without needing additional therapies, Kline noted.

These findings are promising regarding the agent's potential clinical benefit, tolerability, and ongoing disease control once patients cease treatment, Kline stated. Furthermore, the updated follow-up identified no new safety signals, she added. The cohort now includes a small number of patients who have entered a retreatment arm after coming off the drug and experiencing tumor changes that warranted a second course of therapy. Kline expressed excitement over seeing the response data from the 3-year follow-up and the retreatment cohort.

Videos

Cassie Kline, MD, MAS, discusses 3-year follow-up data with tovorafenib in patients with pediatric low-grade glioma from FIREFLY-1. 



Cassie Kline, MD, MAS

Articles

Tovorafenib Yields Long-Term Efficacy in Pediatric Low-Grade Glioma: With Cassie Kline, MD, MAS

Dr Kline on Updated Efficacy Data With Tovorafenib in R/R Pediatric Low Grade Glioma