Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Summary

To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Timeline

Start

2017-10-16

Primary completion

2020-10-13

Completion

2025-09-17

Outcome

Met primary endpoint

registry analysis (superiority test); Tebentafusp vs Investigator's Choice; p <0.0001; Hazard Ratio (HR) 0.51 (95% CI 0.37 to 0.71); Log Rank NCT03070392 ↗

release “KIMMTRAK demonstrated long-term survival benefit in HLA-A*02:01 positive patients with previously untreated metastatic uveal melanoma” immunocore.com ↗

release “The OS Hazard Ratio (HR) favored KIMMTRAK, HR=0.68 (95% CI: 0.54 to 0.87), over investigator’s choice.” immunocore.com ↗

Publications

• Piperno-Neumann S, Rutkowski P, Hassel JC, Butler MO, Schlaak M, Sullivan RJ, Dummer R, Kirkwood JM, Sacco JJ, Shoushtari AN, Piulats JM, Salama AKS, Orloff MM, Joshua AM, Ochsenreither S, Gastaud L, Curti BD, Demidov LV, Milhem MM, Chmielowski B, Kendra KL, Ascierto PA, Bernicker EH, Carvajal RD, Collins L, Lockwood S, Patel JM, Hamid OA, Baurain JF, Nathan PD. Five-year survival with tebentafusp in metastatic uveal melanoma. Ann Oncol. 2026 May 19:S0923-7534(26)00879-3. doi: 10.1016/j.annonc.2026.05.695. Online ahead of print.
• Hassel JC, Piperno-Neumann S, Rutkowski P, Baurain JF, Schlaak M, Butler MO, Sullivan RJ, Dummer R, Kirkwood JM, Orloff M, Sacco JJ, Ochsenreither S, Joshua AM, Gastaud L, Curti B, Piulats JM, Salama AKS, Shoushtari AN, Demidov L, Milhem M, Chmielowski B, Kim KB, Carvajal RD, Hamid O, Collins L, Ranade K, Holland C, Pfeiffer C, Nathan P. Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2023 Dec 14;389(24):2256-2266. doi: 10.1056/NEJMoa2304753. Epub 2023 Oct 21.
• Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dacarbazine	Small molecule	1000 mg/m2	Intravenous
Comparator	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Comparator	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous
Comparator	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Tebentafusp	Protein / enzyme biologic	68 ug	Intravenous

Indications