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Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.


ABSTRACT: BACKGROUND:Mucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319). METHODS:Patients received pembrolizumab 2?mg/kg every 3 weeks (Q3W) or 10?mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1. RESULTS:1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1?+?to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients. CONCLUSION:Pembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.

SUBMITTER: Hamid O 

PROVIDER: S-EPMC6173747 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.

Hamid Omid O   Robert Caroline C   Ribas Antoni A   Hodi F Stephen FS   Walpole Euan E   Daud Adil A   Arance Ana S AS   Brown Ewan E   Hoeller Christoph C   Mortier Laurent L   Schachter Jacob J   Long Jianmin J   Ebbinghaus Scot S   Ibrahim Nageatte N   Butler Marcus M  

British journal of cancer 20180911 6


<h4>Background</h4>Mucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).<h4>Methods</h4>Patients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.<h4>Results</h4>1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 we  ...[more]

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