On November 13, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer and infectious diseases, reported 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 (Press release, Immunocore, NOV 13, 2017, View Source [SID1234521949]).
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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) (Free SITC Whitepaper) 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 (Free SITC Whitepaper) website at View Source