Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma Following recent consultation with FDA, all patients randomized from start of TEBE-AM Phase 2/3 trial will be included in the Phase 3 intent-to-treat population Phase 3 will continue three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control Expected to accelerate time to final Phase 3 overall survival analysis (OXFORDSHIRE, England & CONSHOHOCKEN, PA & ROCKVILLE, MD, US, 29 May 2024) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced that the TEBE-AM Phase 2/3 clinical trial has been converted into a Phase 3 trial.

Immunocore将2/3期TEBE-AM临床试验转化为注册3期试验，评估KIMMTRAK治疗先前治疗的晚期皮肤黑色素瘤最近与FDA协商后，从TEBE-AM 2/3期试验开始随机分组的所有患者将被纳入3期意向治疗人群3期将继续进行三个阶段：KIMMTRAK单一疗法，KIMMTRAK联合pembrolizumab，以及有望加速最终3期总体生存分析的控制（英国牛津郡和宾夕法尼亚州康舍霍肯和罗克维尔，美国马里兰州，2024年5月29日）Immunocore Holdings plc（纳斯达克：IMCR）（“Immunocore”或“公司”），a商业阶段的生物技术公司开创并提供变革性免疫调节药物，以从根本上改善癌症，传染病和自身免疫性疾病患者的预后，今天宣布TEBE-AM 2/3期临床试验已转化为3期试验。

The Phase 2/3 TEBE-AM trial was designed to evaluate KIMMTRAK® (tebentafusp-tebn), as monotherapy and in combination with pembrolizumab, versus a control arm, for the treatment of patients with previously treated advanced cutaneous melanoma. The trial was originally designed as an adaptive Phase 2/3 trial with the optionality to review Phase 2 data and drop an arm.

2/3期TEBE-AM试验旨在评估KIMMTRAK®（tebentafusp-tebn）作为单一疗法，并与pembrolizumab联合使用，与对照组相比，用于治疗先前治疗的晚期皮肤黑色素瘤患者。该试验最初设计为适应性2/3期试验，可选择审查第2阶段数据并放下手臂。

Following consultation with the FDA, the Company has decided to conduct the trial solely as a Phase 3 with the primary endpoint of overall survival. As a result of the recent rapid accrual, the Company projects that the Phase 3 trial would be mostly enrolled by the time the Phase 2 overall survival would have matured.

在与FDA协商后，该公司决定将该试验仅作为第三阶段进行，主要终点为总生存期。由于最近的快速累积，该公司预计，到第二阶段总体生存期成熟时，第三阶段试验将大部分登记。

In addition, the three arm Phase 3 will allow more robust testing of KIMMTRAK as monotherapy and in combination versus a control arm. Finally, with all pa.

此外，三臂第三阶段将允许对KIMMTRAK进行更强大的测试，作为单一疗法，并与对照组进行组合。最后，所有pa。