Clinical outcomes from a tebentafusp UK expanded access program in patients with metastatic uveal melanoma (mUM)

BackgroundTebentafusp (T), a T Cell Receptor (TCR) bispecific therapeutic (gp100 x CD3) is licensed for the treatment of mUM in HLA A2.01 patients. Between July 2021 and June 2023, T was made available to HLA A2.01 positive patients with mUM in 17 treating centres in the UK.MethodsTreating centres were asked to complete an audit database of anonymised outcomes. Submitting centres ensured local data transfer regulations were satisfied. At the time of abstract submission, survival data had been received on 92 patients and additional clinical data on 75.ResultsThe audited population (n=75) had a median age of 62 years (range 18-82), 47% female, 53% male. 58% were ECOG PS 0, 39% PS1, 3% PS2. 66% had no previous systemic treatment. 25% had previous hepatic local treatment. 47% had hepatic only disease, 47% both hepatic + extra-hepatic, 6% extra-hepatic only. LDH was normal in 47%, 33% > 1x ULN, 20% > 2x ULNi.v. fluid support was required in 43% patients on wk 1, 37% wk 2, 29% wk 3, 13% wk 4, 4% week 5. G3-4 rash was seen in 17% of patients on wk 1, 16% wk 2, 14% wk 3, 4% wk 4. Corticosteroids were administered to 24% of patients wk1, 20% wk 2, 9% wk 3, 1% wk 4. Response data is currently available for 66 patients. Responses were investigator assessed: CR 3%, PR 12%, SD 51.5%, PD 33.5%. ORR 15%. Median PFS was 2.53 months (95% CI 2.3-2.76) (n=66) Median OS was 19 months (n=92).ConclusionsThis real-world dataset of patients with mUM receiving tebentafusp demonstrates clinically meaningful survival benefit compared with historical datasets. The proportion of patients requiring fluid or corticosteroid is of interest for resource planning. Updated data and additional clinical outcomes will be presented.Legal entity responsible for the studyThe authors.FundingImmunocore provided a grant for a data manager to PN's institution.DisclosureP. Nathan: Financial Interests, Personal, Advisory Board: BMS, Immunocore, Novartis, Merck, Pfizer, 4SC, IDEAYA; Financial Interests, Institutional, Other, research support: Immunocore; Financial Interests, Personal, Invited Speaker: Novartis, Immunocore; Financial Interests, Institutional, Coordinating PI: BMS, Novartis, Ipsen, Immunocore, Merck, Pfizer; Financial Interests, Personal, Steering Committee Member: 4SC. J.J. Sacco: Financial Interests, Personal, Advisory Board, I have received honoraria for participation on advisory boards, both personal and to institution: Immunocore; Financial Interests, Institutional, Advisory Board: Immunocore, Replimune; Financial Interests, Personal, Advisory Board: Delcath; Financial Interests, Institutional, Local PI: Immunocore, Replimune, Qbiotics, MSD; Financial Interests, Institutional, Research Grant: Immunocore, AstraZeneca, BMS; Other, Other, Travel and conference costs: MSD. A. Furness: Financial Interests, Personal, Invited Speaker, Speaker fees: Bristol Myers Squibb, Ipsen, Eisai; Financial Interests, Personal, Advisory Board, Advisory Board: Immunocore; Financial Interests, Personal, Invited Speaker, Educational event - speaker: Merck, Pfizer; Financial Interests, Personal, Invited Speaker, Speaker - travel/accommodation: ESMO; Financial Interests, Personal, Advisory Board, Travel/Accommodation: Iovance Biotherapeutics; Financial Interests, Personal, Advisory Board: Achilles Therapeutics, GSK, Neogene, Immunocore; Non-Financial Interests, Advisory Role: Erase Mesothelioma. D.J. McMahon: Financial Interests, Institutional, Research Grant, *LungCaDet Study“Temporal evolution of oncogenic driver mutations and biomarkers of non-small cell lung cancer (NSCLC) patients in serum and tumour tissue (Lung CaDet)�The LungCadet study is an ongoing prospective translational research study developed by Dr David McMahon and Dr Dearbhaile Collins aiming to identify and track the evolution of pre-identified oncogenic-driver mutation(s) in serum and tumour tissue of NSCLC patients with and without targeted treatment pressures: Pfizer, Roche; Other, Other, Travel: Takeda. L.T. Khoja: Financial Interests, Personal, Full or part-time Employment, I work as a global development lead in early medical oncology in research and development,. I also hold honorary contracts with my medical institution and university: Bayer AG. P. Serra-Bellver: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Almirall. O. Oladipo: Financial Interests, Personal, Advisory Board: MSD, BMS; Financial Interests, Institutional, Invited Speaker, Educational meetings: BMS; Other, Other, Registration sponsorship for virtual attendance at international meeting: Novartis. H. Shaw: Financial Interests, Personal, Invited Speaker: Novartis, ScanCell, MSD, BMS, Eisai, AstraZeneca, Sanofi; Financial Interests, Personal, Advisory Board: Immunocore, Therakos/Mallinkrodt, ScanCell, CDR-Life, Regeneron, MSD; Financial Interests, Personal, Writing Engagement: Sanofi; Financial Interests, Institutional, Coordinating PI: Immunocore, Iovance, Ideaya, MSD; Financial Interests, Institutional, Local PI: Immunocore, ScanCell, MSD; Financial Interests, Institutional, Steering Committee Member: Immunocore; Financial Interests, Personal, Steering Committee Member: BMS; Financial Interests, Institutional, Funding, Data manager funding: Immunocore; Financial Interests, Institutional, Funding, Immunotherapy nurse pilot project funding - JWP: MSD; Non-Financial Interests, Advisory Role, Non-remunerated advisory role: NovalGen; Non-Financial Interests, Advisory Role: iOnctura, Agenus. All other authors have declared no conflicts of interest.