La combinación de dabrafenib y trametinib podría convertirse en el nuevo tratamiento estándar para el glioma pediátrico de bajo grado, según Cancer Therapy Advisor.

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Related News Adjuvant Dabrafenib Plus Trametinib Deemed Promising for Stage IIIA Melanoma Durvalumab Plus Bevacizumab and TACE: A New Standard of Care for HCC?

Trametinib Slows Recurrent Low-Grade Serous Ovarian Carcinoma Dabrafenib plus trametinib may be a new standard of care for pediatric patients with BRAF V600-mutant low-grade glioma, according to research presented at the 2022 ASCO Annual Meeting. In a phase 2 trial, dabrafenib plus trametinib improved the overall response rate (ORR) and prolonged progression-free survival (PFS), compared with standard chemotherapy. These results represent “a big milestone for the pediatric oncology community, ” said Eric Bouffet, MD, of the Hospital for Sick Children in Toronto, who presented the results at the meeting. “For the first time, we see a combination of non-chemotherapy agents … that demonstrated significant improvement compared to the standard of care in the first-line setting, ” he added. The study (ClinicalTrials. gov Identifier: NCT02684058) enrolled 110 children (ages 1 to 17 years) with BRAF V600-mutant low-grade glioma who had not received prior treatment with a BRAF or MEK inhibitor. Patients either had progressive disease after surgery or they were nonsurgical candidates who required systemic treatment. The patients were randomly assigned to receive dabrafenib plus trametinib (n=73) or carboplatin plus vincristine (n=37). The median age was 10 years in the dabrafenib-trametinib arm and 8 years in the chemotherapy arm. Roughly 60% of patients in each arm were female. The median follow-up was 18.9 months. The ORR and clinical benefit rate (CBR) were significantly higher with the targeted therapy than with chemotherapy. The ORR was 47% with dabrafenib-trametinib and 11% with chemotherapy (odds ratio, 7.2;

95% CI, 2.3-22.4; P The median duration of response (DOR) was longer with chemotherapy. The median DOR was not reached with chemotherapy and was 20.3 months with dabrafenib-trametinib. However, the median PFS was significantly longer with targeted therapy. The median PFS was 20.1 months with dabrafenib-trametinib and 7.4 months with chemotherapy (hazard ratio, 0.31;

95% CI, 0.17-0.55;

P The overall survival data were immature at the time of analysis. There was 1 death in the chemotherapy arm and no deaths in the dabrafenib-trametinib arm. Grade 3 or higher adverse events (AEs) were less common in the dabrafenib-trametinib arm than in the chemotherapy arm — 47% and 94%, respectively — as were AEs of any grade that led to treatment discontinuation — 4% and 18%, respectively. AEs that were more common in the dabrafenib-trametinib than in the chemotherapy arm were pyrexia (68% vs 18%), headache (47% vs 27%), diarrhea (29% vs 18%), and dry skin (26% vs 3%). Disclosures: This research was supported by Novartis. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. Bouffet E, Hansford J, Garré ML, et al. Primary analysis of a phase II trial of dabrafenib plus trametinib (dab + tram) in BRAF V600–mutant pediatric low-grade glioma (pLGG). Presented at ASCO 2022;

June 3-7,2022. Abstract LBA2002. Adjuvant Dabrafenib Plus Trametinib Deemed Promising for Stage IIIA Melanoma Durvalumab Plus Bevacizumab and TACE: A New Standard of Care for HCC? Trametinib Slows Recurrent Low-Grade Serous Ovarian Carcinoma