On December 3, 2020 Immunocore (or the "Company"), a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that it will present new clinical results on tebentafusp (IMCgp100) at the European Society of Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress on the 12th December (Press release, Immunocore, DEC 3, 2020, View Source [SID1234572135]). These data represent the primary clinical results from a Phase 2 study of tebentafusp in previously treated, metastatic uveal melanoma (mUM) patients.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Phase 2 study investigated the overall response rate (ORR), with secondary objectives being overall survival (OS) and safety in 127 patients who had enrolled after progressing on one or more prior therapies. During the session, Dr. Joseph Sacco, Consultant in Medical Oncology, Clatterbridge Cancer Centre, will present the clinical results from the trial.
"In this phase 2 study of previously treated metastatic uveal melanoma, we observed a promising survival that replicates the overall survival benefit we recently reported in our randomized phase 3 study in previously untreated patients," said David Berman, Head of Research and Development at Immunocore. "TCR bispecifics represent a new frontier in IO which will require matching science to clinical observation. Because the proposed mechanism of action includes redirecting T cells into a solid tumor, the survival benefit in patients treated with tebentafusp showed the potential to extend beyond RECIST-defined response rate to also include immune-related responses."
In this Phase 2 study, the overall RECIST-defined response rate (ORR) was 5%, with 45% of patients achieving stable disease. Among patients with evaluable tumours, 44% had reduction in the sum of target lesions, including demonstration of immune-related responses.
Median overall survival (OS) was 16.8 months, with a 12-month OS rate of 62%. The historical 12-month OS rate in previously treated patients is approximately 40%.
Patients who developed a rash, a proposed on-target adverse event (AE), within 7 days of starting tebentafusp had a 12-month OS rate of 77% compared to approximately 40% of those who did not develop a rash. Patients with any reduction in the sum of target lesions, including those with immune-related responses, had a 12-month OS rate of 86%.
Treatment-related AEs were consistent with the proposed mechanism of action, and were generally manageable and decreased in severity after the first three doses; only 3.7% of patients discontinued treatment due to a related AE and there were no fatal treatment-related AEs.