N Engl J Med 2021: The overall survival benefit of tebentafusp in patients with metastatic uveal melanoma

Uveal melanoma is the most common intraocular malignant tumor in adults, accounting for 3% to 5% of all melanomas .
Although uveal melanoma originates from melanocytes, it is different from skin melanoma.
The two have different molecular driving factors and metastasis patterns, as well as different tumor- immune microenvironments .
It is currently believed that these differences lead to poor clinical efficacy after systemic treatment (including immune checkpoint suppression therapy) in patients with uveal melanoma .
As many as 50% of patients with uveal melanoma will have metastases, the main site of metastasis is the liver, and the prognosis of such patients is very poor; the median overall survival is about 1 year, and there is currently a lack of data on the survival benefits of systemic therapy .
 

Uveal melanoma is the most common intraocular malignant tumor in adults, accounting for 3% to 5% of all melanomas .

Although uveal melanoma originates from melanocytes, it is different from skin melanoma.
The two have different molecular driving factors and metastasis patterns, as well as different tumor- immune microenvironments .
It is currently believed that these differences lead to poor clinical efficacy after systemic treatment (including immune checkpoint suppression therapy) in patients with uveal melanoma .
Up to 50% of patients with uveal melanoma metastasis occurs, the liver is the major site of metastasis, and poor prognosis of these patients; median overall survival is about one year, immunization is currently lacking on data survival benefit of systemic therapy .

The molecule called the anti-cancer immune mobilization monoclonal T cell receptor (ImmTAC) is a new class of T cell redirection bispecific fusion proteins that use engineered high affinity T cell receptors to target any protein, including Intracellular antigens appear on the surface of target cells in the form of peptide-HLA complexes

In a single-group phase 2 study involving 127 previously treated patients with metastatic uveal melanoma, tebentafusp monotherapy showed a more promising overall survival than historical controls

Experimental method: Experimental method: Experimental method:

Patients were randomly assigned to receive tebentafusp (tebentafusp group) or the single agent pembrolizumab, ipilimumab, or dacarbazine selected by the investigator at a 2:1 ratio (control group)
.

It has previously been shown that increasing the dose of tebentafusp in patients can reduce toxic effects

Patients were randomly assigned to receive tebentafusp (tebentafusp group) or the single agent pembrolizumab, ipilimumab, or dacarbazine selected by the investigator at a 2:1 ratio (control group)

Primary endpoint The primary endpoint is the overall survival as assessed in the time-to-event analysis

Secondary endpoints Secondary endpoints include disease control (defined as complete response, partial response, or stable disease for ≥12 weeks, according to RECIST version 1.

Result: Result: Result:

A total of 378 patients were randomly assigned to the tebentafusp group (252 patients) or the control group (126 patients)
.

In intention-to-treat, the 1-year overall survival rate was 73% in the tebentafusp group and 59% in the control group (hazard ratio of death, 0.

A total of 378 patients were randomly assigned to the tebentafusp group (252 patients) or the control group (126 patients)

In patients with previously untreated metastatic uveal melanoma, treatment with tebentafusp resulted in longer overall survival than control treatment
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