Immunocore presents Phase 2 tebentafusp clinical results at ESMO Immuno-Oncology Virtual Congress 2020

PRESS RELEASE

Immunocore presents Phase 2 tebentafusp clinical results at
ESMO Immuno-Oncology Virtual Congress 2020

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 3 December 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, today announced 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 12^th December. These data represent the primary clinical results from a Phase 2 study of tebentafusp in previously treated, metastatic uveal melanoma (mUM) patients.

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.

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About Immunocore

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore’s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated monotherapy activity in a Phase 2 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, and is currently being studied in an ongoing Phase 3 clinical trial.  Collaboration partners include Genentech, GlaxoSmithKline, AstraZeneca, Eli Lilly and Company, and the Bill and Melinda Gates Foundation. Immunocore is headquartered at Milton Park, Oxfordshire, U.K., with offices in Conshohocken, Pennsylvania and Rockville, Maryland in the United States. For more information, please visit www.immunocore.com.

About ImmTAC® Molecules

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumours. 

About Tebentafusp

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Fast Track Designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment.[1],[2] Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases/year in the US).[3],[4],[5] Up to 50% of people with uveal melanoma will eventually develop metastatic disease.1,2 When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.[6]

For more information, please contact:

Immunocore
Debra Nielsen, Head of Communications
T: +1 (610) 368-8602
E: [email protected]
Follow on Twitter: @Immunocore

Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji
T: +44 (0)203 709 5700
E: [email protected]

[1] Damato BE, Dukes J, Goodall H, Carvajal RD. Tebentafusp: T cell redirection for the treatment of metastatic uveal melanoma. Cancers. 2019;11(7):971.

[2] Carvajal, RD, Schwartz, GK, Tezel, T, et al., 2017. Metastatic disease from uveal melanoma: treatment options and future prospects. British Journal of Ophthalmology, 101(1), 38-44.

[3]   Pandiani C, Béranger GE, Leclerc J, Ballotti R, Bertolotto C. Focus on cutaneous and uveal melanoma specificities. Genes Dev. 2017;31(8):724-743.

[4]   Jovanovic P, Mihajlovic M, Djordjevic-Jocic J, Vlajkovic S, Cekic S, Stefanovic V. Ocular melanoma: an overview of the current status. Int J Clin Exp Pathol. 2013;6(7):1230-1244.

[5]   About ocular melanoma. Ocular Melanoma Foundation website. www.ocularmelanoma.org​/about-om.htm. Accessed September 2019.

[6]   Rantala ES, Hernberg M, Kivelä TT. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res 2019