KIMMTRAK has been approved in Canada and Australia for the treatment of an aggressive form of ocular melanoma and follows approval in the United States and the European Union PETACH TIKVAH, Israel, June 8, 2022 /PRNewswire/ -- Today, Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, is pleased to announce the approval of KIMMTRAK(tebentafusp) by Health Canada and Therapeutics Goods Administration (TGA) for the treatment of unresectable or metastatic uveal melanoma (mUM), a rare and aggressive form of melanoma that affects the eye. KIMMTRAK was developed by Immunocore Holdings plc ("Immunocore"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. The approval will enable Medison to commercialize KIMMTRAK (tebentafusp) in Canada and Australia, as part of a multi-territorial agreement between Medison and Immunocore, covering a total of 24 markets in Canada, Israel,20 markets across Central Eastern Europe, as well as Australia and New Zealand. "We are pleased to provide patients in Canada and Australia with access to this breakthrough therapy, as part of our multi-territorial partnership with Immunocore", saidMeir Jakobsohn, Founder and CEO of Medison. "We look forward to continuing the momentum and reaching more patients around the globe". "The approvals of KIMMTRAK by Health Canada and TGA are a milestone for uveal melanoma patients in Canada and Australia," said Victor PapamoniodisVP International Markets at Medison. "We are proud to make this breakthrough treatment available to Canadian and Australian patients and we are working diligently to secure additional approvals in the rest of our countries." "The approval of KIMMTRAK by Health Canada and TGA represent another positive step forward for uveal melanoma patients. As a team, we are extremely proud that this groundbreaking treatment can now be made available to patients in over 30 countries around the world," said Mark Moyer, Head of Regulatory Affairs at Immunocore. "To have achieved this in such a short period of time demonstrates the impact that international initiatives such as Project Orbis, which enabled these rapid approvals, can have in providing faster patient access to innovative cancer treatments in countries outside of the US and EU." "For years, metastatic uveal melanoma patients have had to make do with therapeutic options not ideally suited for their condition," said. Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Medical Oncology Site Lead at Princess Margaret Cancer Centre in Toronto, Canada. "Today's approval of tebentafusp represents a paradigm shift in the treatment of unresectable or metastatic uveal melanoma and offers patients with new hope and a chance at longer survival." About Uveal Melanoma Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare. Up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK. About KIMMTRAK KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. KIMMTRAK Clinical Review Health Canada's approval is based on the results of Immunocore's Phase 3 IMCgp100-202 clinical trial, a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK compared to investigator's choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). IMPORTANT SAFETY INFORMATION Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS. In the randomised Phase 3 trial of KIMMTRAK, treatment-related adverse reactions were generally manageable and consistent with the proposed mechanism of action. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse events were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in <1% of patients and were generally well-managed. There were no Grade 4 or higher CRS events observed in the Phase 3 clinical trial. Skin Reactions Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions. Elevated Liver Enzymes Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior tothe start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity. Embryo-Fetal Toxicity KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose. The most common adverse reactions (30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate. For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS). About Medison Pharma Medison 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 glob