FDA Approval Insights: Dabrafenib Plus Trametinib for BRAF V600E–Mutated Unresectable or Metastatic Solid Tumors

Welcome to OncLive On Air^®! I’m your host today, Caroline Seymour.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® 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 Vivek Subbiah, MD, an associate professor in the Investigational Cancer Therapeutics Department and the Center Clinical Medical Director of the Clinical Center for Targeted Therapy, Cancer Medicine Division, at The University of Texas MD Anderson Cancer Center. Subbiah joined us to discuss the FDA approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) in solid tumors with BRAF V600E mutations.

On June 22, 2022, the FDA approved the combination of dabrafenib and trametinib in adult and pediatric patients at least 6 years of age with BRAF V600E–mutant metastatic or unresectable solid tumors who have progressed after previous treatments and who have no satisfactory alternative treatment options.

This regulatory decision was based on findings from 3 clinical trials: the phase 2 ROAR basket study (NCT02034110), arm H of the NCI-MATCH study (NCT02465060), and Study X2101 (NCT02124772).

In the ROAR trial and arm H of the NCI-MATCH trial, the doublet elicited overall response rates (ORRs) of up to 80% in adult patients with BRAF V600E–mutant solid tumors, including biliary tract cancer, high- and low-grade glioma, and certain gastrointestinal and gynecological cancers. In particular, the ORR was 46% (95% CI, 31%-61%) in patients with biliary tract cancer, 33% (95% CI, 20%-48%) in those with high-grade glioma, 50% (95% CI, 23%-77%) in those with low-grade glioma, 50% in those with adenocarcinoma of the small intestine, and 80% in those with low-grade serous ovarian cancer.

Data from Study X2101, which enrolled pediatric patients with recurrent or refractory solid tumors, showed an ORR of 25% (95% CI, 12%-42%) with the combination.

Across all 3 trials, the toxicity profile of dabrafenib plus trametinib was found to be consistent with the doublet’s known profile in other indications.

In our exclusive interview, Subbiah highlighted the significance of this approval and contextualized these data for rare tumor types.

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