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February 3, 2022

Immunocore breaks new ground with a first FDA approval in uveal melanoma

Gaining a marketing authorisation in Europe will be crucial to Kimmtrak’s commercial success in the uveal melanoma space.

By GlobalData Healthcare

Uveal melanoma is a rare, intraocular cancer with localised presentation in the majority of cases. While metastatic uveal melanoma (mUM) is rare, the prognosis of such patients is very poor, as there are no approved therapies available. Last month, Immunocore achieved the first US Food and Drug Administration (FDA) approval of a systemic therapy for mUM patients for its T-cell receptor (TCR) bispecific agent Kimmtrak (tebentafusp-tebn). Importantly, this coincides with the first approval of any TCR therapeutic across oncology.

The FDA approval was based on results from the Phase II IMCgp100-202 trial, which randomised eligible patients at a 2:1 ratio to receive Kimmtrak or an investigator’s choice. In the intention-to-treat population, at the time of data cut-off, the median overall survival was 21.7 months in the Kimmtrak group compared with 16 months in the control group (hazard ratio:0.51). Kimmtrak led to 44% of patients treated experiencing Grade ≥ III adverse events (AEs) versus 17% in the control group. The most common Grade III or higher AE was rash. In addition, 89% of patients experienced cytokine release syndrome, which, however, was below Grade III. These AEs suggest a very manageable side effect profile for Kimmtrak.

Typical off-label options for mUM include immune checkpoint inhibitors (ICIs) and the chemotherapeutic dacarbazine. Kimmtrak is a bispecific fusion protein containing a human TCR that recognises the gp100 antigen on the surface of melanoma cells, as well as an anti-CD3 domain that binds and recruits cytotoxic T-cells to the tumour. The efficacy of this novel mechanism of action is an important milestone for immunotherapy in oncology. GlobalData expects the clinically proven superiority of Kimmtrak to lead to extremely high physician adoption, making it the de facto standard of care in the frontline therapy segment of mUM.

Gaining a marketing authorisation in Europe will be crucial to Kimmtrak’s commercial success. With an authorisation application submitted under accelerated assessment in August last year, Kimmtrak could see an entry in European markets as early as the third quarter of this year. Other late-stage trials for mUM include ICIs such as Merck’s Keytruda (pembrolizumab) and Bristol-Myers Squibbs’ Opdivo (nivolumab) in combination with relatlimab, and the tyrosine kinase inhibitor combination, Verastem’s defactinib + VS-6766. Given Kimmtrak’s first-mover advantage and clear trial outcome, however, it is unlikely that these competitors will erode significant market share from Kimmtrak in the absence of superiority evidence in a head-to-head comparison. GlobalData’s consensus analyst forecasts estimate Kimmtrak to achieve global sales of $122m by 2025.

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