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Melanoma Field Continues to Shift With Targeted Therapy, Immunotherapy Approvals

Caroline Seymour
Published: Thursday, Jul 26, 2018

Joseph Stilwill, MD

Joseph Stilwill, MD

A number of the findings in melanoma presented at the 2018 ASCO Annual Meeting were in the adjuvant setting, reporting benefits with BRAF/MEK inhibition as well as anti–PD-1 therapies, said Joseph Stilwill, MD, a medical oncologist at the Sarah Cannon Research Institute.

In June 2018, the FDA approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for patients with BRAF-mutant unresectable or metastatic melanoma. The approval came following results of the phase III COLUMBUS trial, which were presented at ASCO.

Data from the trial showed a 39% reduction in the risk of death with the combination compared with vemurafenib (Zelboraf) at a median follow-up of 36.8 months.1 The 3-year overall survival (OS) rates were 47% with the combination versus 32% with single-agent vemurafenib.

In the same week, the FDA accepted a supplemental biologics license application for the use of adjuvant pembrolizumab (Keytruda) for patients with resected, high-risk stage III melanoma. The application was based on data from the phase III EORTC 1325-MG/KEYNOTE-054 trial, which demonstrated a 43% reduction in the risk of recurrence or death with adjuvant pembrolizumab versus placebo.2

Results also showed the 1-year recurrence-free survival rate was 75.4% (95% CI, 71.3%-78.9%) with pembrolizumab versus 61.0% (95% CI, 56.5%-65.1%) with placebo (HR, 0.57; 98.4% CI, 0.43-0.74; P <.0001).

The PD-1 inhibitor nivolumab (Opdivo) is also approved by the FDA in this setting, suggesting that anti–PD-1 therapies have a considerable role to play in the adjuvant space.

The unanswered question, said Stilwell, is whether BRAF/MEK inhibition in combination with immunotherapy is worth exploring. And in metastatic disease, the optimal sequence of therapies continues to be refined.

In an interview during the 2018 OncLive® State of the Science Summit™, A Summer of Progress: Updates from ASCO 2018, Stilwill addressed recent advances in melanoma and the focus of research moving forward.

OncLive: What did you focus on in your presentation on melanoma?

Stilwill: The really exciting advances in melanoma over the last year [have been in the] adjuvant [setting], both in the BRAF-positive population as well as in the general population. BRAF and MEK inhibition, as well as anti–PD-1 therapy, have shown a significant benefit in the adjuvant setting and are less toxic than [previously approved] adjuvant therapy.


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Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Evolving Roles for Targeted Melanoma Therapies: Assessing Rapid Progress in the Field and Looking Toward Future CombinationsFeb 28, 20191.5
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