Though it may start as an isolated tumor of the eye, uveal melanoma (UM) metastasizes in up to 50% of patients, becoming a systemic disease.1

As metastatic UM (mUM) runs its course, treatment options are limited and patients face a median survival of up to 12 months.2 So, when you see mUM, think fast.

ThinkUvealMelanoma.com©2020 Immunocore Ltd. All rights reserved. This brochure is intended for healthcare professionals.

What is uveal melanoma,

and why should youthink fast

when you see it?

2

The following information is intended to elevate awareness of uveal melanoma as a condition distinct from cutaneous melanoma (CM).3-6 UM has a poor prognosis if not detected early, and currently, there is no universally

accepted optimal management or treatment for metastatic UM.1,3,7,8

Want to learn more?Visit ThinkUvealMelanoma.com for more information

on UM risk factors and symptoms and to sign up for e-mails featuring clinical perspectives and patient resources.

About uveal melanoma

Presentation and symptoms, risk factors

and management

Pages 3-5

Uveal melanoma vs cutaneous

melanomaIntrinsic differences

between UM and CM

Pages 6-9

Advanced uveal melanoma

Guideline-based recommendations

for mUM

Pages 10-14

3

When you see uveal melanoma,think fast

“I was fitted for the contacts, and afterward, during the eye exam, the ophthalmologist said, ‘There’s a shadow in the back of your left eye. May I dilate your eye?’

He came back and said, ‘I’ve scheduled an appointment for you to see a specialist . . . I was hoping I wouldn’t need to tell you this, but this may be a matter of life and death.

I’m very serious—you need to keep this eye appointment.’”

—Patient with UM

About uveal melanoma

4

Uveal melanoma is a rare tumor of the eye1,9

UM is the most common primary intraocular malignancy.10 While UM can arise from melanocytes anywhere in the uveal tract, it most commonly occurs in the choroid.9

Other, less common primary intraocular malignancies include vitreoretinal lymphoma and retinoblastoma.14

≈8,000 people per year

are diagnosed with UM globally.5

MELANOMA OF THE CILIARY BODY

Difficult to detect

5%-8%

MELANOMA OF THE CHOROIDDifficult to detect

85%-90%MELANOMA OF THE IRIS

Readily detectable

3%-5%

Location of UM by type9,11-13

• 1,600-2,000 are diagnosed in the US12,15

• ≈2,500 are diagnosed in the EU2716

• UM accounts for only ≈4% of all melanomas1,10

EU27, the 27 countries constituting the European Union.

5

Detection and diagnosisThe vast majority of cases of UM, more than 90%, show no signs of systemic disease at diagnosis.17 To learn more about the symptoms, visit ThinkUvealMelanoma.com.Given that patient survival correlates with tumor size and staging, early and accurate diagnosis is particularly important for patient outcomes.18-21 Detection and diagnosis of UM can be challenging depending on the size, location, and appearance of the lesion.9,11-13

Would you recognize a patient at risk?Risk factors that predispose patients to developing UM include:• Caucasian9 • light-colored irides2

• median age: 62 years, with peak incidence at 55 years3,9,22,a

• BAP1 mutation6

aPati ents carrying the BAP1 mutati on typically present at a younger age, between 30 and 59 years of age.3

BAP1, BRCA1-associated protein 1; BRCA1, breast cancer 1.

Additional risk factors may include:Preexisting medical conditions such as congenital ocular melanocytosis, melanocytoma, neurofibromatosis,

and ocular nevi (benign melanocytic lesions that can rarely develop into melanomas).2,9,19

Patient treatment and prognosisSurgery and radiation are the primary treatment options for UM3,24

Enucleation (removal of the eye) does not seem to improve survival compared with brachytherapy (focal delivery of radiation to the tumor). Therefore, treatment for primary disease has focused on vision- and eye-preserving techniques.3

Symptoms of UMCloser investigation may be warranted if your patients are experiencing10,23:

• blurred vision• visual field defects• photopsia

• metamorphopsia• other symptoms

Approximately 30% of pati ents with UM present without symptoms.10 Pati ents can also present with headache, experience ocular pain, or report seeing fl ashes of light. Thus, annual dilated eye exams may be benefi cial. Care must be taken to consider UM as a source of these symptoms, since att ributi ng these symptoms to migraine, sinusiti s, dental infecti on, or emoti onal distress may result in delayed diagnosis.23

6

Histologically, UM and CM may look similar, but they are actually unique diseases. While UM and CM both arise from melanocytes, they have distinct mechanisms of

disease and require different therapeutic approaches.3-6

Courtesy of Prof Sarah Coupland, George Holt Chair in Pathology, Honorary Consultant Histopathologist, University of Liverpool, UK.

UM CM

Uveal melanoma vs cutaneous melanoma

When you see uveal melanoma,think differently

Distinct genotypes and phenotypesThe differences in oncogenic drivers and immunogenicity between UM and CM result in distinct mechanisms of disease.5

UMGNAQ/GNA11

CMBRAF

SF3B1 NRAS

EIF1AX MEK1/2

CYSTLR2 PIK3CA

ΡLCβ4

AKT1/AKT3

PIK3CG

RAC1

KIT

Oncogenic drivers of UM and CM5

7

• No therapy has demonstrated a substantial benefit specifically for patients with metastatic UM3,7

• Numerous therapies have demonstrated a benefit for patients with metastatic CM27,29

While treatment options for UM are limited, patients should be referred to a multidisciplinary team for consideration of available systemic options.1,3,19

They especially differ in the number

of efficacious systemic treatment

options.3,7,27-29

Intrinsically differentAt all stages of disease, UM and CM are intrinsically different in:

UM

8,000 new cases per year globallyThe number of affected patients5

CM

230,000 new cases per year globally

No UV radiation—driven mutationsa

Familial inheritance: ≈1%-2%Oncogenic drivers: GNAQ, GNA11

UV radiation—driven mutation: yesFamilial inheritance: ≈10%Oncogenic drivers: BRAF, NRAS

How they develop5

Up to 50% of patientsdevelop metastases3

≈16% of patients develop metastases25

How often they metastasize

Hematogenous spread, most commonly to the liver

Lymphatic and hematogenous spread to lymph nodes, lungs, liver, bones, and brain

How and where they metastasize5

Poor and has remained stagnant;median survival of ≈6-12 monthsfor patients with distant metastases3,5,7,8

Improving, with many new treatment options; combination therapies have demonstrated median survival of ≥24 months for patientswith advanced disease5,26,27

Their prognosis

No therapy has demonstrated a substantial benefit specifically forpatients with metastatic UM

Numerous therapies havedemonstrated a benefit for patients with metastatic CM

The number of FDA-approved systemic treatment options formetastatic disease

a May be a risk factor for iris melanoma.

8

Metastatic diseaseAlthough local control of tumors is associated with impressive response rates, up to 50% of patients will go on to develop metastatic UM.1,30

LUNGS

SKIN

LIVER

BONES

Sites of metastasis5,31

UM cells spread hematogenously, most commonly metastasizing to the liver and becoming

a systemic disease that can also involve the lungs, skin, and bones.5,31

Rationale for checkpoint inhibitorsImmunotherapy has increasingly become the latest pillar of systemic therapy in oncology, and the recent approvals of checkpoint inhibitors for CM have served as breakthrough options for many patients.5 Unfortunately, these therapies have not demonstrated the same efficacy in the treatment of UM.1,5,32

In addition to having different oncogenic drivers, UM and CM have distinct mutation burdens.5,33

Rationale for targeted therapiesBecause CM has a high incidence of BRAF mutations, effective treatment options for CM include anti-BRAF and anti-MEK therapies.5

Because UM lacks BRAF mutations, there is little support for the use of anti-BRAF therapies in the treatment of UM.5

9

Tumor mutation burden varies by tumor type33

In a study of more than 100 tumor types, CM was among those with the highest tumor mutation burden, while UM was among those with the lowest.

UM tumor immunogenicityThe immune tumor microenvironment factors into the distinction between UM and CM. While CM contains adequate numbers of effector T cells and is inflamed (“hot”), the effector T cells surrounding UM are limited to the tumor periphery (immunologically “cold”).32-36

mUM mCM

PD-L1 expression differs significantly between metastases of UM and those of CM. Only 5.1% (4 of 78) of metastatic UM specimens expressed PD-L1 in comparison to 26.1% (77 of 295) of metastatic CM specimens.32

mCM, metastatic cutaneous melanoma; mUM, metastatic uveal melanoma; PD-L1, programmed death ligand 1.

Mb, megabase.

From Immunotherapy (2017) 9(16), 1323-1330. Reproduced with permission.32

Disease

Skin squamous cell carcinoma

Skin melanoma

Lung squamous cell carcinoma

Brain glioblastoma

Eye intraocular melanoma

Bone marrow myelodysplastic syndrome

0 10 100

Mutations/Mb

10

While guidelines for the management of UM are emerging, evidence-based treatments for progressive disease are still needed.3,30

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uveal Melanoma were first published in 2018 and were most recently updated in May 2020.6,37

Other national guidelines include2,19,38-40:• Guidance from the National Cancer Institute (NCI)• Uveal Melanoma UK National Guidelines (NICE-accredited)• The French Cancer Society• The Netherlands’ Recommendations for Uveal Melanomas Treatment Guidelines• A consensus-based guideline from Canada

Advanced uveal melanoma

When you see uveal melanoma progress,

think collaboratively

11

Surveillance defined by metastatic riskStudies have indicated that the risk for metastasis varies and is influenced by clinical and histological characteristics of the patient and the tumor, including41-43:• tumor diameter• degree of pigmentation• high mitotic rate• somatic mutations in the tumor• tumor thickness• ciliary body involvement• advanced age• male gender

Guidelines recommend surveillance by a multidisciplinary team to identify mUM, but acknowledge that patients should understand both the benefits and the risks of surveillance.2,37,40,44 Unfortunately, surveillance and early detection have generally not been linked to improved outcomes,18 likely due to the lack of universally accepted effective therapies for mUM.1,7,8 Several factors do support surveillance, and its use is likely to become more important as more effective treatments for metastatic disease become available.45

≈50% of patients

with mUMsurvive for one year

after diagnosis.8

Poor prognosis for advanced diseaseWhile effective therapies targeting the primary tumor in the eye have been developed, up to half of patients develop metastatic disease, most commonly spreading to the liver.1,30 The prognosis for metastatic uveal melanoma remains poor, with a median survival of up to 12 months.3,5,7,8

12

DiseaseOverall survival for mUM treated withconvent ional chemotherapy or immunotherapy8

Ove

rall

surv

ival

(%)

Time (years)

20

40

60

80

100

00 1 2 3 4 5

272 114 39 19 6 1CHT318 76 13 3 1 0CPI

Numberat risk

CPICHT

P = 0.0002

From Melanoma Res (2019) 29(6), 561-568. Used with permission.

CHT, conventional chemotherapy (fotemustine, treosulfan + gemcitabine, cisplatin + treosulfan + gemcitabine, dacarbazine, DHA-paclitaxel, or temozolomide + bevacizumab); CPI, checkpoint inhibitor (anti-CTLA4 antibody, anti–PD-1/anti–PD-L1 antibody).

Therapeutic options for mUM offer only

modest efficacy, and clinical trials are currently the recommended course

of treatment, when clinically

appropriate.1,7,8,37

13

Risk stratification to determine the frequency of follow-up systemic imaging should be based on the highest risk factor present37

Low risk37

• Class 1A46

• Disomy 3• Gain of chromosome 6p• EIF1AX mutation• T1 (AJCC)• Spindle cells

Surveillance imaging recommendationa:Consider surveillance imaging every 12 months

Medium risk37

• Class 1B46

• SF3B1 mutation• T2 and T3 (AJCC)• Mixed histology

(spindle and epithelioid cells)

Surveillance imaging recommendationa:Consider surveillance imaging every 6-12 months for 10 years, then as clinically indicated

High risk37

• Class 246

• Monosomy 3• Gain of chromosome 8q• BAP1 mutation• PRAME expression• T4 (AJCC)• Epithelioid cells• Extraocular extension• Ciliary body involvement

Surveillance imaging recommendationa:Consider surveillance imaging every 3-6 months for 5 years, then every 6-12 months for years 6-10, then as clinically indicated

AJCC, American Joint Committee on Cancer.a The most frequent sites of metastasis are liver, lungs, skin/soft tissue, and bones. For patients who elect to have surveillance imaging, options include contrast-

enhanced magnetic resonance or ultrasound of the liver, with modality preference determined by expertise at the treating institution. Additional imaging modalities may include chest/abdominal/pelvic computed tomography with contrast. However, screening should limit radiation exposure whenever possible. Scans should be performed with IV contrast unless contraindicated. Recognizing that there are limited options for systemic recurrence and that regular imaging may cause patient anxiety, patients should discuss with their treating physician the benefits of surveillance imaging, and some patients may elect to forgo surveillance imaging. Participation in a clinical trial is strongly encouraged.37

NCCN Guidelines® for Uveal Melanoma recommend stratification by risk for distant metastasis to determine frequency of systemic imaging during follow-up.37

14

Taking a multidisciplinary approachWhile no approved therapy has demonstrated a substantial benefit specifically for patients with mUM,3,7 guidelines recommend a multidisciplinary approach to the management of metastatic disease.2,37,40,44

Multidisciplinary teams may include expertise from the following areas2,40,44:• Medical oncology• Ophthalmology• Radiology and radiotherapy• Pathology• Surgical oncology• Nursing specialist• Hepatology

A collaborative approach may help optimize outcomes for patients with mUM.1

Liver-specific imaging* is common

due to the high rate ofmetastasis to the liver.

Liver function tests are likely inadequate based on

current evidence.2,6,18,40

*Eg, ultrasound, magnetic resonance imaging, and computed tomography.

15

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New NCCN Guidelines for uveal melanoma and treatment of recurrent or progressive distant metastatic melanoma. J Natl Compr Canc Netw. 2018;16(5.5):646-650. doi:10.6004/jnccn.2018.0042 7. Khoja L, Atenafu EG, Suciu S, et al. Meta-analysis in metastatic uveal melanoma to determine progression free and overall survival benchmarks: an International Rare Cancers Initiative (IRCI) ocular melanoma study. Ann Oncol. 2019;30(8):1370-1380. doi:10.1093/annonc/mdz176 8. Rantala ES, Hernberg M, Kivelä TT. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. Published online. 2019;29(6):561-568. doi:10.1097/CMR .0000000000000575 9. Krantz BA, Dave N, Komatsubara KM, Marr BP, Carvajal RD. Uveal melanoma: epidemiology, etiology, and treatment of primary disease. Clin Ophthalmol. 2017;11:279-289. doi:10.2147/OPTH.S89591 10. Mahendraraj K, Lau CSM, Lee I, Chamberlain RS. Trends in incidence, survival, and management of uveal melanoma: a population-based study of 7,516 patients from the Surveillance, Epidemiology, and End Results database (1973–2012). Clin Ophthalmol. Published online October 25, 2016. 2016;10:2113-2119. doi:10.2147/OPTH.S113623 11. Kaliki S, Shields CL. Uveal melanoma: relatively rare but deadly cancer. Eye. 2017;31(2):241-257. doi:10.1038/eye.2016.275 12. Jovanovic P, Mihajlovic M, Djordjevic-Jocic J, Vlajkovic S, Cekic S, Stefanovic V. Ocular melanoma: an overview of the current status. Int J Clin Exp Pathol. 2013;6(7):1230-1244. Accessed July 16, 2020. http://www.ijcep.com/files/ijcep1304033.pdf 13. Tarlan B, Kıratlı H. Uveal melanoma: current trends in diagnosis and management. Turk J Ophthalmol. 2016;46(3):123-137. doi:10.4274/tjo.37431 14. Nagarkatti-Gude N, Wang Y, Ali MJ, Honavar SG, Jager MJ, Chan CC. Genetics of primary intraocular tumors. Ocul Immunol Inflamm. 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Management of uveal melanoma: a consensus-based provincial clinical practice guideline. Curr Oncol. 2016;23(1):e57-e64. doi:10.3747/co.23.2859 20. Damato B, Eleuteri A, Taktak AFG, Coupland SE. Estimating prognosis for survival after treatment of choroidal melanoma. Prog Retin Eye Res. 2011;30(5):285-295. doi:10.1016/j.preteyeres.2011.05.003 21. DeParis SW, Taktak A, Eleuteri A, et al. External validation of the Liverpool Uveal Melanoma Prognosticator Online. Invest Ophthalmol Vis Sci. 2016;57(14):6116-6122. doi:10.1167/iovs.16-19654 22. Virgili G, Gatta G, Ciccolallo L, et al; EUROCARE Working Group. Incidence of uveal melanoma in Europe. Ophthalmology. 2007;114(12): 2309-2315, 2315.e1-2315.e2. doi:10.1016/j.ophtha.2007.01.032 23. Rishi PR, Shields CL, Khan MA, Patrick K, Shields JA. Headache or eye pain as the presenting feature of uveal melanoma. Ophthalmology. 2013;120(9):1946-1947, 1946.e1-1947.e2. doi:10.1016/j.ophtha.2013.06.015 24. Collaborative Ocular Melanoma Study (COMS) Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, V: twelve-year mortality rates and prognostic factors: COMS report no. 28. Arch Ophthalmol. 2006;124:1684-1693, E1-E3. doi:10.1001 /archopht.124.12.1684 25. Zbytek B, Carlson JA, Granese J, Ross J, Mihm MC Jr, Slominski A. Current concepts of metastasis in melanoma. Expert Rev Dermatol. Published online August 1, 2009. 2008;3(5):569-585. doi:10.1586/17469872.3.5.569 26. Leonardi GC, Falzone L, Salemi R, et al. Cutaneous melanoma: from pathogenesis to therapy (review). Int J Oncol. 2018;52(4):1071-1080. doi:10.3892/ijo.2018.4287 27. Pasquali S, Hadjinicolaou AV, Chiarion SV, Rossi CR, Mocellin S. Systemic treatments for metastatic cutaneous melanoma (review). Cochrane Library. Accessed July 16, 2020. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011123.pub2/epdf/full 28. Violanti SS, Bononi I, Gallenga CE, Martini F, Tognon M, Perri P. New insights into molecular oncogenesis and therapy of uveal melanoma. Cancers (Basel). 2019;11(5):694. doi:10.3390/cancers11050694 29. Drugs approved for skin cancer. National Cancer Institute. Updated June 29, 2020. Accessed July 16, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/skin#3 30. Steeb T, Hayani KM, Fӧrster P, et al. Guidelines for uveal melanoma: a critical appraisal of systematically identified guidelines using the AGREE II and AGREE-REX instrument. J Cancer Res Clin Oncol. 2020;146(4):1079-1088. doi:10.1007/s00432-020-03141-w 31. Carvajal RD. Management of metastatic uveal melanoma. UpToDate. Updated September 30, 2019. Accessed April 14, 2020. https://www.uptodate.com/contents/management-of-metastatic-uveal-melanoma 32. Javed A, Arguello D, Johnston C, et al. PD-L1 expression in tumor metastasis is different between uveal melanoma and cutaneous melanoma. Immunotherapy. 2017;9(16): 1323-1330. doi:10.2217/imt-2017-0066 33. Chalmers ZR, Connelly CF, Fabrizio D, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017;19(1):34. doi:10.1186/s13073-017-0424-2 34. Krishna Y, McCarthy C, Kalirai H, Coupland SE. Inflammatory cell infiltrates in advanced metastatic uveal melanoma. Hum Pathol. 2017;66:159-166. doi:10.1016/j.humpath .2017.06.005 35. Qin Y, de Macedo MP, Reuben A, et al. Parallel profiling of immune infiltrate subsets in uveal melanoma versus cutaneous melanoma unveils similarities and differences: a pilot study. Oncoimmunology. 2017;6(6):e1321187. doi:10.1080/2162402X.2017.1321187 36. Rothermel LD, Sabesan AC, Stephens DJ, et al. Identification of an immunogenic subset of metastatic uveal melanoma. Clin Cancer Res. Published online May 1, 2017. 2016;22(9):2237-2249. doi:10.1158/1078-0432.CCR-15-2294 37. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uveal Melanoma V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed August 6, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 38. Intraocular (uveal) melanoma treatment (PDQ®)–health professional version. National Cancer Institute. Updated December 17, 2019. Accessed July 16, 2020. https://www.cancer.gov/types/eye/hp/intraocular-melanoma-treatment-pdq 39. Mathis T, Cassoux N, Tardy M, et al. Management of uveal melanomas, guidelines for oncologists. Article in French. Bull Cancer. Published online September 11, 2018. 2018;105(10):967-980. doi:10.1016/j.bulcan.2018.07.011 40. The Netherlands’ recommendations for uveal melanoma (eye melanoma) treatment guidelines. Published 2017. 41. Vaquero-Garcia J, Lalonde E, Ewens KG, et al. PRiMeUM: a model for predicting risk of metastasis in uveal melanoma. Invest Ophthalmol Vis Sci. 2017;58(10):4096-4105. doi:10.1167/iovs.17-22255 42. Corrêa ZM. Assessing prognosis in uveal melanoma. Cancer Control. 2016;23(2):93-98. doi:10.1177/107327481602300202 43. Gill HS, Char DH. Uveal melanoma prognostication: from lesion size and cell type to molecular class. Can J Ophthalmol. 2012;47(3):246-253. doi:10.1016/j.jcjo.2012.03.038 44. Nathan P, Cohen V, Coupland S, et al. Uveal melanoma national guidelines. Melanoma Focus. Published January 2015. Accessed July 16, 2020. http://melanomafocus.com/wp-content /uploads/2015/01/Uveal-Melanoma-National-Guidelines-Full-v5.3.pdf 45. Francis JH, Patel SP, Gombos DS, Carvajal RD. Surveillance options for patients with uveal melanoma following definitive management. In: Dizon DS, ed. American Society of Clinical Oncology Educational Book. Vol 33. American Society of Clinical Oncology; 2013:382-387. doi:10.14694/EdBook_AM.2013.33.382 46. Onken MD, Worley LA, Char DH, et al. Collaborative Ocular Oncology Group report no. 1: prospective validation of a multi-gene prognostic assay in uveal melanoma. Ophthalmology. Published online August 1, 2013. 2012;119(8):1596-1603. doi:10.1016/j.ophtha.2012.02.017

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