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

Omid Hamid, Caroline Robert, Antoni Ribas, F Stephen Hodi, Euan Walpole, Adil Daud, Ana S Arance, Ewan Brown, Christoph Hoeller, Laurent Mortier, Jacob Schachter, Jianmin Long, Scot Ebbinghaus, Nageatte Ibrahim, Marcus Butler, Omid Hamid, Caroline Robert, Antoni Ribas, F Stephen Hodi, Euan Walpole, Adil Daud, Ana S Arance, Ewan Brown, Christoph Hoeller, Laurent Mortier, Jacob Schachter, Jianmin Long, Scot Ebbinghaus, Nageatte Ibrahim, Marcus Butler

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.

Conflict of interest statement

O.H. reports personal fees for serving as a consultant to Amgen, Novartis, Roche, Bristol-Myers Squib (BMS), and Merck Sharp & Dohme (MSD), as a speaker for Amgen, BMS, Genentech, and Novartis, and support for contracted research from Astra Zeneca, BMS, Celldex, Genentech, Immunocore, Incyte, MSD, Merck Serono, MedImmune, Novartis, Pfizer, Rinat, and Roche. C.R. reports personal fees from serving on advisory boards for BMS. A.R. reports personal fees for serving as a consultant to MSD, and for serving as an SAB member for Kite Pharma, Five Prime, CytomX, Compugen, and Advaxis. F.S.H. reports grants to his institution from MSD, personal fees for serving as a consultant to Amgen, BMS, Celldex, EMD Serono, Genentech, and MSD, and royalties from a pending patent for MICA-related disorders. E.W. reports grants from MSD, Merck Serono, and Roche. A.D. reports personal fees from Novartis, Pfizer, Genentech, BMS, MSD, grants from MSD, and stock in OncoSec. C.H. reports personal fees from MSD, BMS, Amgen, Novartis, Roche, Pierre Fabre, and Incyte. L.M. reports personal fees from medical board with MSD France. J.S. reports personal fees and fees from serving as an SAB member for BMS and MSD. J.L., S.E., and N.I. are employees of MSD. J.L. and S.E. hold stock in MSD. N.I. holds stock in MSD and GSK. M.B. reports personal fees as an advisory board member from BMS, Novartis, Immunocore, Immunovaccine, EMD Serono, Turnstone, and MSD. A.S.A. and E.B. report no competing interests.

Figures

Fig. 1
Fig. 1
Antitumour activity. Response rates (a) and durability of response (b) with pembrolizumab in mucosal and nonmucosal melanoma
Fig. 2
Fig. 2
Survival outcomes. Progression-free (a) and overall survival (b) with pembrolizumab in mucosal and nonmucosal melanoma

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Source: PubMed

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