Novartis’ targeted drug combination therapy has been recommended by the National Institute for Health and Care Excellence (NICE) to treat paediatric brain cancer patients in England and Wales.
The Finlee (dabrafenib) and Spexotras (trametinib) combination, which can be taken orally at home, has been recommended by the agency to treat patients aged one year and over with low-grade or high-grade gliomas that have a BRAF V600E mutation.
The combination can be used by patients with low-grade glioma (LGG) who require systemic treatment, while eligible high-grade glioma (HGG) patients will have received at least one course of radiation or chemotherapy treatment.
Gliomas are the most common type of brain cancer in paediatric patients and can be classified as either LGG, where tumours do not grow or grow slowly, or HGG, where tumours grow more rapidly and are usually fatal.
Novartis’ drug combination works by targeting the proteins made by the altered BRAF gene that are responsible for uncontrollable tumour growth.
NICE’s final draft guidance on the therapy was supported by positive results from the phase 2/3 TADPOLE trial, in which LGG patients randomised to receive the combination experienced a response rate more than four times higher than those receiving chemotherapy, at 47% and 11%, respectively. At a median follow-up of 18.9 months, median progression-free survival was 20.1 months for the combination cohort compared to 7.4 months for chemotherapy.
The study also demonstrated positive outcomes for patients with more aggressive BRAF V600E mutation-positive HGG, with an overall response rate of 56% as well as a mediation duration of response of 22 months and a median overall survival of 33 months for the combination group. This is compared to conventional therapy, where response rates were below 12% and the median survival was 5.6 months.
Marie Andrée Gamache, country president, Novartis UK and Ireland, said: “We are humbled to be part of [the] international scientific community effort in developing targeted therapies based on the unique genetic features of a patient’s tumour and welcome NICE’s decision to make the treatment available for patients in England and Wales.
“This recent appraisal is an example of how we can address the biggest clinical and public health challenges in the UK through collaboration and make the progress that’s needed for patients to benefit most.”
Gamache added that the company is working with the Scottish Medicines Consortium “to provide equitable access to the treatment across the UK”.