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Poster Discussion session - Melanoma and other skin tumours

5352 - Efficacy of Pembrolizumab (Pembro) in Patients (Pts) With Advanced Melanoma with Stable Brain Metastases (BM) at Baseline: A Pooled Retrospective Analysis


20 Oct 2018


Poster Discussion session - Melanoma and other skin tumours



Tumour Site



Omid Hamid


Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289


O. Hamid1, A. Ribas2, A. Daud3, M.O. Butler4, M.S. Carlino5, W. Hwu6, G.V. Long7, K. Ancell8, F..S. Hodi9, N.I. Khushalani10, C.U. Blank11, C. Loquai12, J. Lin13, S.J. Diede13, C. Robert14

Author affiliations

  • 1 Medical Oncology And Hematology, The Angeles Clinic and Research Institute, 90025 - Los Angeles/US
  • 2 Medical Oncology, Ronald Reagan UCLA Medical Center, 90095-1781 - Los Angeles/US
  • 3 Medicine, University of California, San Francisco, San Francisco/US
  • 4 Medical Oncology, UHN Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA
  • 5 Medical Oncology, Westmead Hospital, 2145 - Westmead/AU
  • 6 Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 7 Medical Oncology, Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, 2060 - Sydney/AU
  • 8 Medical Oncology, Vanderbilt-Ingram Cancer Center, Nashville/US
  • 9 Medical Oncology, Dana-Farber Cancer Institute, Boston/US
  • 10 Cutaneous Oncology Program, Moffitt Cancer Center, Tampa/US
  • 11 Medical Oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 12 Dermatology, University Medical Center Mainz, Mainz/DE
  • 13 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 14 Medical Oncology, Gustave Roussy, 94800 - Villejuif/FR


Abstract 5352


BM are common in pts with metastatic melanoma and are usually associated with a pejorative prognosis. Thus, understanding incidence, response, progression, and outcomes of pts with BM treated with immunotherapy is of substantial clinical relevance. This retrospective analysis was conducted to evaluate the efficacy and safety of pembro in pts with and without BM at baseline in KEYNOTE-001, -002, and -006.


Pts with advanced melanoma who had previously treated and stable BM for ≥4 weeks prior to enrollment in KEYNOTE-001, -002, and -006 received pembro: 2 mg/kg Q3W, 10 mg/kg Q2W, or 10 mg/kg Q3W. Groups were pooled given similar efficacy. End points included OS, PFS, ORR, DOR, and safety.


Of the 1561 pts treated with pembro, 157 (10%) had BM at baseline. Median follow-up was 19.2 mo (range 0.2-43.0) in pts with BM vs 19.4 mo (range 0.2-47.7) in pts without BM. Baseline characteristics were similar between cohorts. 24-month OS and PFS, ORR, DCR, and DOR were equivalent (Table). PD occurred in 40% and 42%, respectively. PD occurred in the brain in 59% of pts with BM compared with 10% of pts without BM. AEs of any grade were reported in 97% of pts with BM and 98% of pts without BM; TRAEs were reported in 76% of pts with BM and 81% of pts without BM; grade 3-5 TRAEs were reported in 14% and 17%, respectively. 9% and 8% discontinued due to a TRAE. 2 pts without BM died due to a TRAE.Table: 1248PD

Efficacy of pembro in pts with or without BM at baseline

Patients With BM N = 157Patients Without BM N = 1404
24-mo OS (95% CI), %45 (34.9-54.1)49.0 (45.4-52.3)
24-mo PFS (95% CI), %26 (18.7-33.2)26 (24.1-28.9)
ORRa, %3332
DCRa,b, %4848
CR, %810
PR, %2522
SD, %1314
PD, %3942
DOR (range), moNR (1.3+ to 31.3+)NR (1.1+ to 38.8+)

Extracranial responses. bIncludes non-CR/non-PD pts.


In this pooled retrospective analysis of KEYNOTE-001, -002, and -006, overall efficacy and safety were similar in pts who received pembro regardless of baseline stable BM after local therapy. In pts who had PD, PD occurred in the brain more often in pts with BM at baseline versus those without. These data suggest that pembro is a safe, efficacious treatment for advanced melanoma in pts with and without previously-treated and stable BM at baseline.

Clinical trial identification

NCT01295827 (first posted Feb 15, 2011); NCT01704287 (first posted Oct 11, 2012); NCT01866319 (first posted May 31, 2013).

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.

Editorial Acknowledgement

Medical writing and/or editorial assistance was provided by Trisha Stankiewicz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA.


O. Hamid: Advisory board member: Amgen, Novartis, Roche, BMS, Merck; Speaker's bureau: BMS, Genentech, Novartis, Amgen; Honoraria, Travel expenses: Amgen, Novartis, Roche, BMS, Merck; Other: Contracted research institution: AstraZeneca, BMS, Celldex, Genentech, Immunocore, Incyte, Merck, Merck Serono, MedImmune, Novartis, Pfizer, Rinat, Roche. A. Ribas: Stock ownership: Lutris, PACT, Tango; Advisory board member: Advaxis, Arcus, BioncoTech, Compugen, CytomX, Five Prime, FLX-Bio, ImaginAb, Isoplexis, Kite-Gilead, Rgenix; Honoraria for Amgen, BMS, Chugai, Genentech, Merck, Novartis, Roche. A. Daud: Stock ownership: Oncosec, Cingularity; Advisory board member: Merck, BMS, Gentech/Roche, Regeneron; Research funding: Merck, BMS, Gentech/Roche, Regeneron, Incyte, Curis. M.O. Butler: Advisory board member: Merck Canada, BMS, EMD Serono, Immunovaccine, Immunocore, Novartis. M.S. Carlino: Honoraria: MSD, BMS, Novartis; Consultant/advisory: MSD, BMS, Novartis, Amgen. W-J. Hwu: Consulting/Advisory for Merck, Array; Research funding: Merck, BMS, MedImmune, GSK. G.V. Long: Honoraria: BMS, MSD, Roche, Novartis, Incyte; Consultant/advisory: BMS, Roche, Amgen, MSD, Novartis, Array, Pierre Fabre, Incycte; Travel, accomodations and expenses: MSD, Roche (travel support to conference). F.S. Hodi: Advisory board member: Merck, Bristol-Myers Squibb, Novartis, EMD Serono, Sanofi; Research funding (institution): Bristol-Myers Squibb. N.I. Khushalani: Stock ownership: Mazor Robotics, Bellicum Pharmaceuticals; Advisory board member: Bristol Myers-Squibb, EMD Serono, HUYA Bioscience, Regeneron, Genentech; Research funding: Bristol Myers-Squibb, Merck, Novartis, GlaxoSmithKline, HUYA, Regeneron, Amgen (all to Institution); Other: Data safety monitoring board: AstraZeneca. C.U. Blank: Stock: Verastem; Consulting/advisory: MSD, BMS, Roche, Novartis, Pfizer, Lilly, GSK; Research funding: Novartis, BMS; Travel, accommodations: MSD, Pfizer, Roche. C. Loquai: Advisory board member: BMS, Novartis, Roche, MSD, Amgen, Pierre Fabre, Leo; Speakers’ bureau: BMS, Novartis, Roche, MSD, Amgen, Pierre Fabre, Leo; Honoraria: BMS, Novartis, Roche, MSD, Amgen, Pierre Fabre, Leo; Travel expenses, including accommodations: BMS, Novartis, Roche, MSD, Amgen, Pierre Fabre, Leo. J. Lin, S.J. Diede: Employee, Stockholder: Merck. C. Robert: Honoraria, Consultant/advisory: BMS, Merck, GSK, Roche, Amgen, Novartis. All other authors have declared no conflicts of interest.

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