Table 1

Clinical and immunological data for each participant

VMMAge at enrollmentSexECOG PSPrimary
melanoma site
Stage at enrollmentLDH level at enrollment (U/L)*Biopsiable tumor†PD-1 Ab naïvePD-L1 status‡BRAF V600E/K mutation statusHigh durable T cell responseDurable T cell RspT cell RspOn treatment monthBest RECIST responseSurvival statusSurvival duration (months)§
101472M1Skin, acralIV202YesNoN/AWTNoNo Yes¶ May 2018PDDeceased31.51
108863F0Skin, non-acralIV146YesNo20%WTNoNoNoFebruary 2018PDAlive45.77
126572M0Skin, non-acralIV231YesNoN/AWTNoNoNoOctober 2016PDDeceased10.45
127436F0Skin, non-acralIV177NoNoN/AV600ENoNoNoMarch 2017SDDeceased47.38
127562F1Skin, non-acralIV515NoNoN/AV600ENoNoNoMarch 2017PDDeceased4.34
128448F1Anal, mucosalIV334NoNoN/AWTNoNoNoNovember 2017PDDeceased10.22
128775F0Skin, acralIV221NoNoN/AV600ENoNoNoNovember 2017SDDeceased20.86
129054F0Skin, non-acralIV156NoNo0%V600ENoNo Yese,f March 2018 PR Alive45.01
129148M1Skin, non-acralIV3177YesNo<1%V600ENoNoNoApril 2018PDDeceased2.50
129357M0UvealIV400NoNo0%WTNoNoNoMay 2018PDDeceased6.77
129664M0Anal, mucosalIV198NoNo50%–60%WTNoNoNoAugust 2018PDDeceased10.55
129750F1Skin, acralIV404YesNoN/AWTNoNoNoAugust 2018PDDeceased3.48
130156M0Skin, acralIV280YesNo>95%WTNoNoNoJanuary 2019SDDeceased26.38
130270M1Skin, non-acralIV195YesNo75%WTNoNoNoMarch 2019PDDeceased3.61
130567F1Skin, acralIV274YesNo2%–3%WTNoNoNoJun 2019PDDeceased24.41
130663M0UvealIV186YesNo5%WTNo Yes Yes¶ Jun 2019SDDeceased19.48
127274F0Skin, non-acralIV155Yes Yes <1%V600ENoNoNoDecember 2016PDDeceased43.33
127681M0Skin, non-acralIV250Yes Yes N/AN/ANoNo Yes April 2017 CR Alive54.44
127844M0Skin, non-acralIIIC184No Yes 20%–25%V600E Yes Yes Yes¶ June 2017 PR Alive52.70
128569M0Skin, non-acralIV177No Yes 5%–10%WTNoNo Yes¶ November 2017 PR Alive47.54
129579M1Skin, non-acralIV223No Yes 10%WTNoNoNoJuly 2018 PR Deceased37.49
129960M1UvealIV992Yes Yes <1%WTNoNo Yes¶ October 2018PDAlive37.32
  • Bolded text highlights participants who were PD-1 Ab naïve, had a T cell Rsp, or had a PR or CR.

  • *The normal range for blood LDH level is between 125 and 250 U/L.

  • †Participants who had one or more additional sites of metastasis available for biopsy pretreatment and on day 22.

  • ‡Per cent of tumor cells expressing PD-L1.

  • §Survival duration was calculated from the start of study treatment through the date of last follow-up or date of death.

  • ¶Participants who had a fivefold T cell Rsp (hRsp).

  • **VMM 1290 had no T cell Rsp in peripheral blood mononuclear cells, but did have a T cell Rsp (Rsp and hRsp) in the sentinel immunized node.

  • Ab, antibody; CR, complete response; ECOG, Eastern Cooperative Oncology Group; F, female; hRsp, high T cell response; LDH, lactic acid dehydrogenase; M, male; N/A, not applicable or unknown; PD-1, programmed cell death protein 1; PD, progressive disease; PD-L1, programmed death-ligand 1; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumors; response, Rsp; SD, stable disease; VMM, Virginia Malignant Melanoma; WT, wild type.