Immunocore Holdings plc...announces that the European Commission (EC) has approved KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.

KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Systemic for distant metastatic disease...Preferred regimens...Tebentafusp-tebn in patients who are HLA A*02:01-positive (category 1)

At a minimum follow-up of 36 months, median overall survival was 21.6 months in the tebentafusp group and 16.9 months in the control group (hazard ratio for death, 0.68; 95% confidence interval, 0.54 to 0.87)….This 3-year analysis supported a continued long-term benefit of tebentafusp for overall survival among adult HLA-A*02:01–positive patients with previously untreated metastatic uveal melanoma.

Immunocore Holdings plc...today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Treatment with tebentafusp resulted in longer overall survival than the control therapy among previously untreated patients with metastatic uveal melanoma.

FDA grants Priority Review to tebentafusp for the treatment of HLA-A*02:01-positive patients with metastatic uveal melanoma; with an expected Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2022...United States and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM).

Immunocore...today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Immunocore...announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A*0201-positive with previously untreated, metastatic uveal melanoma (mUM).

...blood for HLA-A testing must be submitted during Screening, and HLA-A*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method....

The eligibility criteria for each trial were very similar (Table 1) with the main distinction being the requirement for patients in the IMCgp100-202 trial to be positive for the HLA-A*02:01 allele...The median OS and 1-year OS rate was 21.7 months and 73% for tebentafusp and 12.6 months and 50% for nivolumab plus ipilimumab....Tebentafusp was previously shown to provide an OS benefit compared to checkpoint inhibitors or chemotherapy in untreated mUM.

Tebe significantly improved overall survival (OS) compared to investigator’s choice of pembrolizumab, ipilimumab or dacarbazine (HR 0.51) in first line (1L) mUM [NCT03070392]. Here we evaluated the impact of subsequent therapy on long-term survival….When adjusting for the effect of subsequent therapy (any or CPI), the OS benefit from the ITT analysis was maintained. In an analysis of survival from the start of any first subsequent therapy, prior tebe patients tended to have longer OS compared to prior IC patients, HR (95% CI) 0.75 (0.55, 1.04)....Based on IPCW analysis, the OS benefit in first line HLA-A*02:01+ mUM patients is predominantly due to tebentafusp and not due to subsequent therapy.

We conducted a Ph2 study of tebe in mUM pts. HLA-A*0201+ pts...While the 1° endpoint of ORR was 5%, 44% pts had reduction in TL. 12 mo OS rate (62% all pts, 86% in pts with TL reduction) was promising.