FDA Accepts Biologics License Application for Tebentafusp in Metastatic Uveal Melanoma


Tebentafusp has demonstrated promising responses in metastatic uveal melanoma, leading to FDA and European Medicines Agency approval of a biologics license application and marketing authorization application for the agent.

The FDA and European Medicines Agency have approved a biologics license application (BLA) and marketing authorization application for tebentafusp (IMCgp100) in the treatment of patients with HLA-A*02:01–positive metastatic uveal melanoma, according to a press release from agent’s developer, Immunocore Holdings.1

The submissions are based on findings from the phase 3 IMCgp100-202 trial (NCT03070392), which evaluated tebentafusp in a population of patients with previously untreated metastatic uveal melanoma.2 Data from the study, which were presented at the 2021 American Association for Cancer Research Annual Meeting, indicated that after a median follow up of 14.1 months, patients treated with the experimental agent experienced a median overall survival (OS) of 21.7 months (95% CI, 18.6-23.6) compared with investigator’s choice of pembrolizumab (Keytruda), ipilimumab (Yervoy), or dacarbazine at 16.0 months (95% CI, 9.7-19.4; stratified HR, 0.51; 95% CI, 0.37-0.71; P <.0001). Moreover, the 1-year OS rate was 73.2% in the tebentafusp arm vs 58.5% in the control arm.

The priority review designation for the novel T-cell receptor bispecific immunotherapy agent could shorten the review period from a standard 10 months to 6 months from the filing acceptance. As such, the anticipated Prescription Drug User Fee Act date is February 23, 2022.

The BLA is currently being reviewed under the Real-Time Oncology pilot program, which is designed to expedite the delivery of tolerable and efficacious treatments for patients with cancer. Tebentafusp is also being assessed by the FDA’s Orbis initiative, which allows for concurrent review by health authorities in partner countries. Previously, the FDA had granted tebentafusp a breakthrough therapy designation as a treatment for adult patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma.

Patients who enrolled on the IMCgp100-202 trial (n = 378) were randomized 2:1 to receive either 20 mcg of tebentafusp on day 1 followed by 30 mcg on day 8 of cycle 1 and 68 mcg on day 15+ or 2 mg/kg of pembrolizumab every 3 weeks, 3 mg/kg of ipilimumab every 3 weeks, or 1000/mg/m2 of dacarbazine every 3 weeks.

With regard to safety, nearly all patients treated with tebentafusp (99.6%) experienced any-grade adverse effects (AEs) and 45% had grade 3/4 AEs. The most common any-grade cytokine-mediated AEs associated with tebentafusp included cytokine release syndrome (89%), pyrexia (76%), chills (47%), nausea (43%), fatigue (41%), and hypotension (38%). Additionally, grade 3/4 rash was reported in 18% of patients and pruritus was reported in 5% of patients.


  1. Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorization application for tebentafusp in metastatic uveal melanoma. News release. August 24, 2021. Accessed August 25, 2021. https://bit.ly/3sTdtwD
  2. Piperno-Neumann S, Hassel JC, Rutkowski P, et al. Phase 3 randomized trial compared tebentafusp with investigator’s choice in first line metastatic uveal melanoma. Cancer Res. 2021;81(13):CT002. doi:10.1158/1538-7445.AM2021-CT002
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