Immunocore Presents Single Agent IMCgp100 data in Metastatic Uveal Melanoma Showing Durability, Doubling in One-Year Overall Survival Rate
~ Data shows a 73% one-year survival rate for metastatic uveal melanoma patients treated in two Phase I studies of IMCgp100 ~
(Oxford, UK and Conshohocken, US, 13 November 2017) Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer and infectious diseases, today announces durable tumour responses and strong overall survival data from two Phase I clinical trials of its wholly owned, lead programme, IMCgp100, in metastatic uveal melanoma.
The data, which show a near doubling in the average rate of overall survival compared with studies of other agents, was presented at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting on Saturday 11th November 2017, at the Gaylord National Resort & Convention Center in National Harbor, Maryland, USA.
Immunocore’s intra-patient dose escalation Phase I IMCgp100 study in metastatic uveal melanoma patients demonstrates a one-year overall survival (OS) rate of 73% (95% confidence interval [46, 88]) and a one-year progression-free-survival (PFS) rate of 62% based on the irRC criteria as of the data cut-off in October 2017. Median OS has not been reached with median follow-up of 12.8 months in this cohort. The overall survival data from this study compare very favourably to studies with other agents, which show one-year OS rates of approximately 25-45%*.
Pharmacodynamic analysis demonstrated evidence of T cell infiltration and immune activation in tumours after IMCgp100 administration, with persistence of T cell infiltration in the setting of resistance, underpinning confidence in the efficacy observed with the T cell redirection technology of IMCgp100.
Commenting on the results, Dr Richard Carvajal, Head of Experimental Therapeutics at Columbia University, said: “Metastatic uveal melanoma is a condition with exceptionally high unmet medical need with no current standard of care in this setting. No therapies to date have shown survival benefits in trials. The exciting one-year overall survival and progression-free survival data we have observed with IMCgp100 have given us confidence to move into pivotal trials measuring survival in this disease setting.”
Christina Coughlin, Chief Medical Officer at Immunocore, said: “We believe this therapy has the potential to be a game-changer for medical practice in this devastating condition. At Immunocore, we’re optimistic that the exceptionally strong data we have seen with IMCgp100 in metastatic uveal melanoma have the potential to read across to other ImmTAC® programmes, especially when addressing ‘cold’ tumours which are challenging for checkpoint inhibitors and other novel immuno-oncology agents to address. We believe that this underscores the broader applicability of Immunocore’s soluble TCR technology in cancer and beyond.”
The details of the clinical trial can be found on clinicaltrials.gov.
Poster Presentation Information
Title: Safety, efficacy and biology of the gp100 TCR-based bispecific T cell redirector, IMCgp100 in advanced uveal melanoma in two Phase 1 trials
Authors: Richard Carvajal, Takami Sato, Alexander N. Shoushtari, Joseph Sacco, Paul Nathan, Marlana Orloff, Pippa Corrie, Neil Steven, Jeff Evans, Jeffrey Infante, Mario Sznol, Clive Mulatero, Omid Hamid, Leonel Hernandez-Aya, Nicola Little, Cheryl McAlpine, David Krige, Namir J. Hassan, Sanjay Patel, Ann-Marie Hulstine, Christina M. Coughlin, Mark R. Middleton
Category: Clinical Trials (Completed)
Date: Saturday 11 November 2017
Time: 12:30 – 14:00 & 18:30 – 20:00
Abstract Number: P208
To view the abstract, please visit the SITC website at https://www.sitcancer.org/2017/abstracts/info
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Notes for editors
Immunocore is the world’s leading T cell receptor (TCR) company, a global biotech striving to change medical practice in the most challenging disease areas. Immunocore is focused on delivering first-in-class biological therapies for patients, deploying its pioneering soluble TCR technology. This new class of TCR-based bi-functional drug with ultra-high affinity for intracellular cancer targets is based on synthetic, soluble TCRs that naturally recognize cells containing disease specific targets and selectively kill them. Unlike most biological treatment modalities, this technology can address both extra and intracellular disease targets. These TCR-based therapeutics can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies. Immunocore’s TCR technology has a broad applicability to a wide range of intracellular targets and disease indications including solid tumours, infectious diseases and autoimmune diseases.
Across the oncology pipeline, Immunocore has collaborations with Genentech, GlaxoSmithKline, MedImmune (the biologics division of AstraZeneca) and a co-discovery and co-development partnership with Lilly across a range of solid tumours. Immunocore’s wholly-owned lead programme, IMCgp100, is in a pivotal monotherapy trial in patients with metastatic uveal melanoma. This study trial builds on the first ever demonstration of compelling single agent efficacy in a solid, ‘cold’, low mutation tumour, which is challenging for most currently available immuno-oncology agents to address. The Company has also entered into combination trials with IMCgp100 in metastatic cutaneous melanoma with MedImmune and in metastatic uveal melanoma with Lilly.
Immunocore is headquartered near Oxford, UK, with offices near Philadelphia, US. The Company is privately held by a broad international and private investor base. For more information, please visit www.immunocore.com.
IMCgp100 is a novel bispecific biologic, an ImmTAC® which is capable of redirecting T cells against the melanocyte-associated antigen gp100. It has a molecular weight of 77 kilo Dalton (kD). IMCgp100 is manufactured in E. coli and scaled to commercial scale. The drug is administered on a weekly basis. In the first-in-human (FIH) clinical trial (IMCgp100-01), preliminary efficacy of IMCgp100 in advanced uveal and cutaneous melanoma was observed. IMCgp100 is the only novel agent that has initiated pivotal studies in metastatic uveal melanoma. IMCgp100 was granted orphan drug designation by the US Food and Drug Administration in 2016.
Immunocore is also conducting a clinical combination study with IMCgp100, combining it with MedImmune’s checkpoint inhibitors durvalumab and tremelimumab in patients with metastatic cutaneous melanoma who are refractory to anti-PD-1 therapies.
In addition to the uveal melanoma study, IMCgp100 is currently in a clinical combination study with MedImmune’s checkpoint inhibitors durvalumab (anti-PDL-1) and tremelimumab (anti-CTLA-4) in patients with metastatic cutaneous melanoma who no longer respond to anti-PD-1 therapies.
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma which affects the eye with a poor prognosis and no standard of care. Although uveal melanoma is the most common primary intraocular malignancy in adults, representing approximately 3-4% of all melanomas, the diagnosis is rare with approximately 4,000 new patients globally diagnosed per year (1,500 cases/year in US) all stages combined (Chattopadhyay, 2016). Despite aggressive local therapy with surgery and/or radiation therapy, the 5-year survival rate (76%) has not changed in over 30 years (Mahendraraj, 2017) and up to 50% of patients with local disease will develop metastates (Carvajal, 2017; Kujala, 2003). Despite extensive investigation of metastatic uveal melanoma in the clinic, to date no systemic treatment has demonstrated improved survival and no effective therapy has been identified in this disease setting (Carvajal, 2017).
Checkpoint inhibitors and other novel therapies that have transformed the management of cutaneous melanoma, only have limited efficacy in uveal melanoma with an overall response rate (ORR) of only ~5%. The median progressive free survival is no more than 3 months with a median overall survival (OS) ranging from 5 to 10 months. Consequently, there is a critical unmet need for new treatment approaches.
About ImmTAC® Molecules
Immunocore’s best in class proprietary TCR technology is focused on a small protein drug called the ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecule that enables the immune system to recognise and kill cancerous cells. Immunocore’s world-leading competitive advantage is its ImmTAC molecules, a new class of drug with ultra-high affinity for intracellular cancer targets, which is based on synthetic, soluble T cell receptors (TCRs) that naturally recognize cells containing disease specific targets and selectively kill them.
ImmTAC molecules can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies. Immunocore’s TCR technology has a broad applicability to a wide range of intracellular targets and disease indications including solid tumours and can expand into infectious diseases and autoimmune diseases. In oncology, the molecules have the unique ability to tackle solid “cold” low mutation rate tumours – the majority of tumours.
The technology has an encouraging safety profile and is highly scalable, with a low cost of goods.