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Neoadjuvant Dabrafenib Plus Trametinib for Stage III Melanoma

By: Lauren Harrison, MS
Posted: Monday, July 8, 2019

The combination of neoadjuvant dabrafenib and trametinib seems to be an effective treatment for patients with stage III melanoma, and the therapy improves relapse-free survival in these patients. However, compared with patients treated with neoadjuvant anti–PD-1 immunotherapy, those treated with this combination therapy still had a high risk of relapse, according to Georgina V. Long, PhD, of the University of Sydney, Australia, and colleagues. These single-center phase II trial (NeoCombi) findings were published in The Lancet Oncology.

“Neoadjuvant dabrafenib plus trametinib therapy could be considered in the management of [Response Evaluation Criteria in Solid Tumors (RECIST)]-measurable resectable stage III melanoma, as it led to a high proportion of patients achieving a complete response according to RECIST and a high proportion of patients achieving a complete pathological response, with no progression during neoadjuvant therapy,” concluded the authors.

From August 2014 to April 2017, 35 patients with stages IIIB to C, BRAF V600­mutant melanoma were enrolled in the trial. Patients received 150 mg of dabrafenib twice daily plus 2 mg of trametinib once daily before resection. At the end of data collection, the median follow-up was 27 months.

After pathologic evaluation and resection, all 35 patients had achieved a pathologic response, and 49% of patients had a complete pathologic response. At the time of resection, 86% of patients achieved a RECIST response, with 46% and 40% of patients achieving complete and partial RECIST responses, respectively. Five patients had stable disease at the time of data collection, and no patients experienced disease progression.  

In total, 6 of the 35 patients had treatment-related serious adverse effects, including pyrexia, syncope, and acute kidney injury. Grade 3 or 4 adverse effects occurred in 29% of patients, most commonly pyrexia (12%). There were no treatment-related deaths reported.

Disclosure: The study authors’ disclosure information may be found at thelancet.com.



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