Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2018 Sep;119(6):670-674.
doi: 10.1038/s41416-018-0207-6. Epub 2018 Sep 11.

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

Omid Hamid  1 , Caroline Robert  2 , Antoni Ribas  3 , F Stephen Hodi  4 , Euan Walpole  5 , Adil Daud  6 , Ana S Arance  7 , Ewan Brown  8 , Christoph Hoeller  9 , Laurent Mortier  10 , Jacob Schachter  11 , Jianmin Long  12 , Scot Ebbinghaus  12 , Nageatte Ibrahim  12 , Marcus Butler  13
Affiliations
Clinical Trial

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

Omid Hamid et al. Br J Cancer. 2018 Sep.

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.

PubMed Disclaimer

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
See this image and copyright information in PMC

Comment in

  • Immunotherapy for mucosal melanoma.
    Yentz S, Lao CD. Yentz S, et al. Ann Transl Med. 2019 Jul;7(Suppl 3):S118. doi: 10.21037/atm.2019.05.62. Ann Transl Med. 2019. PMID: 31576325 Free PMC article. No abstract available.

References

    1. McLaughlin CC, et al. Incidence of noncutaneous melanomas in the U.S. Cancer. 2005;103:1000–1007. doi: 10.1002/cncr.20866. - DOI - PubMed
    1. Patrick RJ, Fenske NA, Messina JL. Primary mucosal melanoma. J. Am. Acad. Dermatol. 2007;56:828–834. doi: 10.1016/j.jaad.2006.06.017. - DOI - PubMed
    1. Shreders A, Joseph RW. Efficacy of immunotherapy for metastatic mucosal melanoma. Immunotherapy. 2016;8:843–845. doi: 10.2217/imt-2016-0036. - DOI - PubMed
    1. Chang AE, Karnell LH, Menck HR. The National Cancer Data Base report on cutaneous and noncutaneous melanoma: a summary of 84,836 cases from the past decade. The American College of Surgeons Commission on Cancer and the American Cancer Society. Cancer. 1998;83:1664–1678. doi: 10.1002/(SICI)1097-0142(19981015)83:8<1664::AID-CNCR23>3.0.CO;2-G. - DOI - PubMed
    1. Yamazaki N, et al. Phase 1b study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced melanoma (KEYNOTE-041) Cancer Chemother. Pharmacol. 2017;79:651–660. doi: 10.1007/s00280-016-3237-x. - DOI - PMC - PubMed

Publication types

Associated data