First-in-class therapy PBS listed for rare cancer of the eye

Pharma News: Unlocking a treatment for uveal melanoma, a rare form of eye cancer, has long challenged scientists. Starting February 1st, patients with this aggressive cancer have access to Kimmtrak (tebentafusp), a first-in-class therapy Pharmaceutical Benefits Scheme (PBS) listed for unresectable or metastatic uveal melanoma.

Professor Anthony Joshua, Chair of the Australasian Ocular Melanoma Alliance (AOMA), emphasised the critical need for effective treatment, stating, “Advanced uveal melanoma is a particularly aggressive form of melanoma with a poor prognosis.” He went on to explain the mechanism of Kimmtrak, likening it to “velcro between the tumour and the immune system,” allowing immune cells to target and attack cancer cells.

The significance of this milestone was underscored by Professor Georgina Long AO, Co-Medical Director of Melanoma Institute Australia and 2024 Australian of the Year. She stated “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.”

The therapy was PBS listed through a first Pharmaceutical Benefits Advisory Committee (PBAC) submission by Medison, the commercialisation partner for Immunocore in Australia. This is Medison’s first PBS launch locally.

Gil Gurfinkel, CEO of Medison Pharma, commented “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.”

The efficacy of Kimmtrak was established through a phase 3 trial involving 378 newly diagnosed patients. The trial compared Kimmtrak to three established treatments, including two immune checkpoint inhibitors and a chemotherapy drug. Of those in the control group, 82% were provided with MSD’s Keytruda. The results demonstrated a significant improvement in the median overall survival (OS), with Kimmtrak showing 21.7 months compared to 16 months for patients in the control group, along with a nearly 50% lower risk of death.

The most severe side effect of the therapy is cytokine release syndrome, necessitating a 16-hour monitoring period after the administration of the first three doses.

Ralph Torbay, Head of Commercial of Immunocore, stated “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, General Manager of Medison Australia, echoed this sentiment, saying, “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.”

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