Sydney, Thursday 1 February, 2024. Medison Pharma, alongside their partner Immunocore Holdings Ltd (NASDAQ: IMCR), is pleased to announce that from today KIMMTRAK® (tebentafusp) is listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma who have not previously received systemic treatment.1,[2],[3]
Uveal melanoma is a rare eye cancer, with an incidence in Australia of approximately 7.6 per million people.[4] This equates to around 150 to 200 Australians being diagnosed with uveal melanoma each year.5 Over time up to half of these patients develop metastasis, where the cancer spreads to other parts of the body[5],[6],[7]
The PBS reimbursement of KIMMTRAK® is specific for the treatment of patients who carry the HLA-A*02:01 gene and have advanced uveal melanoma that has grown despite local treatment or that has spread to other parts of the body.1 KIMMTRAK® contains the active ingredient tebentafusp and is designed to help the body’s own immune cells, called T-cells, destroy the uveal melanoma cancer cells.3 KIMMTRAK® belongs to the class of bispecific T cell directed therapies, developed by Immunocore using their proprietary Immune mobilising monoclonal T cell receptors Against Cancer (ImmTAC) technology.[8],[9]
Professor Anthony Joshua, Chair of the Australasian Ocular Melanoma Alliance (AOMA) said, “Advanced uveal melanoma is a particularly aggressive form of melanoma with a poor prognosis.” [10],[11]
“KIMMTRAK® works by helping immune cells get close enough to cancer cells and then to attack them. It’s like velcro between the tumour and the immune system”, he added.2,3
Professor Georgina Long AO, Co-Medical Director Melanoma Institute Australia said, “This listing makes drug therapy for uveal melanoma accessible to Australian patients and provides us with more tools to tackle this rare form of melanoma.” 1
The reimbursement of KIMMTRAK® is a testament to Medison’s commitment and the value it strives to deliver to patients in Australia battling this rare and severe disease. Gil Gurfinkel, CEO of Medison Pharma said, “We are pleased to see that our unified multi-regional commercial platform is enabling access to this innovative therapy for patients in Australia. Our efforts highlight our deep commitment to innovation, benefiting the communities we serve."
Ralph Torbay, Head of Commercial of Immunocore said, “I am delighted that following the PBS listing, Australian patients can now access KIMMTRAK ®, demonstrating Immunocore’s commitment to bringing our medicines to patients worldwide”.
Adam Maguire, Country Manager of Medison Australia said, “Medison is committed to ensuring Australian patients have access to novel treatments as quickly as possible.”
“The PBS listing of KIMMTRAK® is a significant step forward and we are proud to deliver access to this medicine for Australian patients.”1
About KIMMTRAK® 3
Indication: KIMMTRAK® is used to treat a rare eye cancer called uveal melanoma, when it has grown despite local treatment or has spread to other parts of the body. KIMMTRAK® is only appropriate for adult patients who test positive for the HLA-A*02:01 gene. Patients should speak to their healthcare provider about whether KIMMTRAK® is a suitable treatment option for them.
KIMMTRAK® contains the active ingredient tebentafusp. It is made from two different proteins that are fused together. One of these proteins recognises a target protein called ‘gp100’ which is found in large amounts in uveal melanoma cancer cells. Once the cancer cells are recognised, KIMMTRAK® activates the immune system to destroy the cancer cells.
Administration: KIMMTRAK® is given to the patient by a healthcare professional in a hospital or clinic through an intravenous infusion over 15-20 minutes. KIMMTRAK® is given once a week, for as long the treating doctor thinks treatment is benefitting the patient. More instructions can be found in the KIMMTRAK® Consumer Medicine Information.
Precautions & Interactions: A doctor will determine if KIMMTRAK® is a suitable treatment option for a patient’s uveal melanoma. The doctor will consider the patient’s other medical conditions and medicines taken including pregnancy and breastfeeding.
Side Effects: All medicines can have side effects. Serious side effects with KIMMTRAK® include symptoms of cytokine release syndrome (CRS) such as fever, dizziness, light headedness, difficulty breathing, nausea, vomiting, fatigue, muscle pain, joint pain, swelling, low blood pressure, rapid heart rate, and headache. Other serious side effects include itchy skin, rash, severe hives, peeling or flaking skin, swelling of body and/or skin around the eyes. Very common side effects include decreased appetite, prickling, tingling or numbness in any section of the body, cough, diarrhoea, stomach pain, chills, and abnormal blood tests. Side effects not listed here may occur in some people.
For further information, patients should speak to their doctor and can refer to the KIMMTRAK® Consumer Medicine Information available at www.medisonpharma.com.au/products/kimmtrak or https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01950-1
PBS Information: Section 100 (Efficient Funding of Chemotherapy) for the treatment of HLA‑A*02:01‑positive adult patients with advanced (unresectable or metastatic) uveal melanoma. Authority Required. Please refer to PBS Schedule for full authority information.
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This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
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WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, can occur in patients receiving tebentafusp. Only administer in an appropriate setting. Monitor for at least 16 hours following each of the first three infusions, and then as clinically indicated. |
ENDS
Media Inquiries: Nexus APAC | M: 0437 629 884 | E: Medison@nexusapac.com.au
Disclosure Medison supports disclosure and transparency in interactions between personnel and healthcare professionals to ensure public trust and confidence.
No spokespeople have been offered compensation for their involvement in this media release. All spokespeople have been briefed on the approved use of this product and their obligations regarding promotion to the general public.
KIMMTRAK® is a registered trademark of Immunocore Limited. © 2024 Medison Pharma Australia Pty Ltd, ABN 19 659 723 403, 1-7 Bligh Street, Sydney NSW 2000, www.medisonpharma.com.
Prepared Jan 2024, [AUS-IM-NP-240006].
About Medison Pharma
Medison, the creator and leader of the multi-regional partnership category, is a global pharma company focused on providing access to highly innovative therapies to patients in international markets.
Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.
To learn more visit www.medisonpharma.com.
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune, and infectious disease. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. To learn more visit www.immunocore.com.
About Medison’s Partnership with Immunocore
Medison has a multi-territorial partnership with Immunocore to commercialise KIMMTRAK® across more than 25 countries in five continents for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma. This partnership is central to Medison’s belief that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies.
[1] Pharmaceutical Benefits Advisory Committee Meeting Outcomes September 2023. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2023-09/september-2023-pbac-web-outcomes.pdf. Accessed 17 January 2024.
[2] Kimmtrak Product Information. January 2023. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-01048-1&d=20240118172310101. Accessed 16 January 2024.
[3] Kimmtrak Consumer Medicine Information. January 2023. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01950-1. Accessed 16 January 2024.
[4] Beasley AB, Preen D, et al. Incidence and mortality of uveal melanoma in Australia (1982–2014). Br J Ophthalmol 2021;0:1-6. Available at: https://ro.ecu.edu.au/cgi/viewcontent.cgi?article=12766&context=ecuworkspost2013. Accessed 17 January 2024.
[5] Kujala E, et al. Very long-term prognosis of patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci 2003;44:4651–9; DOI: 10.1167/iovs.03-0538. Available at: https://pubmed.ncbi.nlm.nih.gov/14578381/. Accessed 23 January 2024.
[6] Carvajal RD, et al. Metastatic disease from uveal melanoma: treatment options and future prospects. Br J Ophthalmol 2017;101:38–44. doi: 10.1136/bjophthalmol-2016-309034. Available at: https://pubmed.ncbi.nlm.nih.gov/27574175/. Accessed 23 January 2024.
[7] Kapoor A, et al. Management of uveal tract melanoma: A comprehensive review. J Egypt Natl Canc Inst 2016;28:65–72. doi: 10.1016/j.jnci.2016.02.003. Available at: https://pubmed.ncbi.nlm.nih.gov/26975730/. Accessed 23 January 2024.
[8] Wallace Z, Singh PK, Dorrell L. Combination strategies to durably suppress HIV-1: Soluble T cell receptors. J Virus Erad. 2022 Aug 24;8(3):100082. doi: 10.1016/j.jve.2022.100082. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9440443/. Accessed 23 January 2024.
[9] Damato BE, Dukes J, Goodall H, et al. Tebentafusp: T Cell Redirection for the Treatment of Metastatic Uveal Melanoma. Cancers (Basel). 2019 Jul 11;11(7):971. doi: 10.3390/cancers11070971
[10] Kaliki S, Shields CL. Uveal melanoma: relatively rare but deadly cancer. Eye (Lond). 2017 Feb;31(2):241-257. doi: 10.1038/eye.2016.275. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5306463/. Accessed 23 January 2024.
[11] Krantz BA, Dave N, Komatsubara KM, Marr BP, Carvajal RD. Uveal melanoma: epidemiology, etiology, and treatment of primary disease. Clin Ophthalmol. 2017 Jan 31;11:279-289. doi: 10.2147/OPTH.S89591. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5298817/. Accessed 23 January 2024.