Business Wire

New IMCgp100-102 Data Show Durable Response and Robust Overall Survival Rate in Patients with Metastatic Uveal Melanoma

Share

Patients with metastatic uveal melanoma (mUM) treated with IMCgp100 continued to experience a durable tumour response with a median follow up of 19.1 months, without yet reaching median overall survival (OS), according to new Phase I research to be presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.2 IMCgp100 is the wholly-owned, lead programme from Immunocore Limited, a leading T-cell receptor (TCR) company focused on delivering first-in-class biological therapies that transform lives.

Although rare, uveal melanoma is the most common form of adult eye cancer.3 When it metastasises beyond the eye, less than half of patients will survive for one year.4 Of the 19 HLA-A*0201+ patients enrolled in Phase I of the Phase I/II dose escalation trial, 17 were evaluated for efficacy. Among these patients, treatment with IMCgp100 was associated with an objective response rate of 18% (90% confidence interval [4,30]) and a one-year overall survival rate of 74% (95% confidence interval [48,88]) at the time of data cut-off.2

Survival rates in uveal melanoma have remained largely unchanged for decades, and it is difficult to treat once it advances to metastatic disease,” said Dr. Takami Sato, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University and lead investigator. “These data provide compelling evidence that IMCgp100 may offer hope to this underserved patient population.”

Additional exploratory survival analyses also indicated prolonged OS was associated with a number of pharmacodynamic outcomes, including lymphocyte trafficking, providing encouraging evidence supporting the proposed mechanism of action of IMCgp100.2

Immunocore is focused on transforming the lives of patients with some of the most challenging diseases, such as metastatic uveal melanoma, for which there is currently no standard of care,” said Andrew Hotchkiss, Chief Executive Officer at Immunocore. “Although these are early findings, we are encouraged by the emerging clinical data and focused on advancing our pivotal trials.”

The most common adverse events in the Phase I arm included pruritus (severe itching of the skin; 90%), pyrexia (fever) and fatigue (84%), and hypotension (74%).2 Dose limiting toxicities were observed in 3 patients; all were reversible abnormalities in liver function tests (Grade 3 or 4 ALT/AST changes). There were no IMCgp100-related AEs that resulted in discontinuation or death.2

About Metastatic Uveal Melanoma

Uveal melanoma is an aggressive form of melanoma which affects the eye, with a poor prognosis and no standard of care.5 Although it is the most common primary intraocular malignancy in adults,3 the diagnosis is rare, with approximately 4,000 new patients diagnosed globally each year (1,500 cases/year in US).1 Up to 50% of people with uveal melanoma will eventually develop metastatic disease.5,6 When the cancer spreads beyond the eye, only approximately 40% of patients will survive for one year.4

About the IMCgp100-102 Phase I/II Trial

In this study, IMCgp100 is administered on a weekly basis with an intra-patient escalation dosing regimen. The dose escalation portion of the study has been completed, which identified the recommended Phase II intra-patient dose. The Phase II portion of the study is ongoing evaluating both the safety and efficacy in patients with metastatic uveal melanoma. The currently enrolling cohort is assessing IMCgp100 in patients who have experienced disease progression after 1 or 2 prior lines of therapy, which may include up to 1 line of liver directed therapy. Approximately 150 patients will be enrolled in the Phase II portion and the estimated enrolment completion date is September 2019.

About the IMCgp100 Programme

IMCgp100 is a novel bi-specific biologic T cell redirection therapy that specifically targets the melanoma-associated antigen gp100, and which is now in pivotal studies for mUM. IMCgp100 was granted Orphan Drug Designation by the US Food and Drug Administration in 2016 and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme in 2017. For more information about enrolling IMCgp100 clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT02570308 , NCT03070392).

About ImmTAC® Molecules

Immunocore’s proprietary TCR (T Cell Receptor) technology generates a novel class of bi-specific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that enable the immune system to recognise and kill cancerous cells. ImmTAC molecules are based on synthetic, soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill cancer cells via an anti-CD3 immune-redirecting effector function. ImmTAC molecules can access up to nine-fold more target antigens than typical antibody-based approaches, including monoclonal antibodies. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to tackle solid “cold” low mutation rate tumours, the majority of tumours that do not adequately respond to currently available immunotherapies.

About Immunocore

Immunocore, a leading T Cell Receptor (TCR) biotechnology company, is focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases. The Company’s primary therapeutic focus is oncology and it also has programs in infectious and autoimmune diseases. Immunocore has a pipeline of proprietary and partnered programs in development and the lead programme, IMCgp100, has entered pivotal clinical studies as a treatment for patients with metastatic uveal melanoma. Partners include Genentech, GlaxoSmithKline, AstraZeneca, Lilly, and the Bill and Melinda Gates Foundation. Immunocore is headquartered at Milton Park, Oxfordshire, UK, with an office outside Philadelphia, USA. The Company is privately held by a broad international investor base. For more information, please visit www.immunocore.com.

   
1 Data on file
2

Sato, T. et al. Redirected T cell lysis in patients with metastatic uveal melanoma with gp100-directed TCR IMCgp100: Overall survival findings. Presented at ASCO 2018 (abstract 9521).

3

Mahendraraj K, Lau CS, Lee I, et al., 2016. Trends in incidence, survival, and management of uveal melanoma: a population-based study of 7,516 patients from the surveillance, epidemiology, and end results database (1973–2012). Clinical Ophthalmology, 10, 2113.

4

Khoja L, Atenafu E, Joshua A, and The International Rare Cancer's Initiative-Ocular Melanoma Group. 2016. Meta-analysis of phase II trials in metastatic uveal melanoma (MUM) to determine progression-free (PFS) and overall survival (OS) benchmarks for future phase II trials: An irci-ocular melanoma initiative. Journal of Clinical Oncology 34:15_suppl, 9567-9567.

5

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.

6

Kujala E, Mäkitie T, Kivelä T. 2003. Very long-term prognosis of patients with malignant uveal melanoma. Investigative Ophthalmology & Visual Science, 44, 4651.

 

Contact information

Immunocore
Andrew Hotchkiss, +44 (0) 1235 438600
Chief Executive Officer
info@immunocore.com
Follow on Twitter: @Immunocore
or
Syneos Health Communications (IMCgp100)
Hannah Silver, 212-849-9483
ImmunocorePR@syneoshealth.com
or
Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/Jessica Hodgson/Laura Thornton
+44 (0) 203 709 5700
Immunocore@consilium-comms.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Gilead Sciences to Release Second Quarter 2019 Financial Results on Tuesday, July 30, 201916.7.2019 20:05:00 CESTPress release

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2019 financial results will be released on Tuesday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the second quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 8696029 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the confere

MSCI Schedules Investor Conference Call to Review Second Quarter 2019 Results16.7.2019 14:49:00 CESTPress release

MSCI Inc. (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, announced today it will release its results for second quarter 2019 on Thursday, August 1, 2019. MSCI's senior management will review the second quarter 2019 results on Thursday, August 1, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 7743929 within the United States. International callers dial 1-720-405-2251 conference ID: 7743929. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conclusion of the live event. Through August 4, 2019,

Keio Plaza Hotel Tokyo Offers “Tea Ceremony Experience and Luxurious Accommodations for Families” Package16.7.2019 14:05:00 CESTPress release

Keio Plaza Hotel Tokyo (KPH), one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, will begin offering a special summer accommodation package entitled “Tea Ceremony Experience and Luxurious Accommodations for Families” from July 20 to September 1, 2019. This accommodation package has been specially designed to keep families with children entertained by providing the unique cultural experience of a Japanese tea ceremony as fond memories of their summer vacation at our Hotel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190716005325/en/ With the accommodation package, guests with children could experience unique cultural Japanese tea ceremony to learn how to make a green tea and its history. (Photo: Business Wire) The rooms offered in this accommodation package are the very popular “Two Queen Beds Rooms” located on the “Premier Grand” club floors with use of the Club Lounge included. The rooms are

Andersen Global Enters Senegal, Expands Presence in Africa16.7.2019 13:30:00 CESTPress release

Andersen Global is proud to announce a collaboration agreement with Cabex, one of the oldest legal and tax consulting firms in Senegal. Senegal thus becomes the thirteenth African country where Andersen Global has a member or collaborating firm offering legal services. Located in Dakar, Cabex has been offering services to local and foreign clients from the public and para-public sectors on matters relating to national and international issues for nearly thirty years. “Collaborating with Andersen Global shall expand our international scope and our transborder capabilities while giving us additional opportunities to expand into new markets,” Papa Alassane Ndir, Partner & General Manager at Cabex, said. “Henceforth, we are going to collaborate with many colleagues and experts from around the world and will be in a position to provide our clients more in-depth expertise.” Cherif Diaite, Partner & Technical Manager at Cabex, indicated that, “Owing to the challenge at an international level,

Mercatus Opens UK Office; Hires Chris Webb to Lead European Operations16.7.2019 13:00:00 CESTPress release

Mercatus, a leading asset and investment management platform for alternative investors and asset managers, today announced the opening of its European Headquarters in London, UK and the addition of Chris Webb as Senior Director leading the office in London. Chris was formerly a Global Director of Strategic Business Growth at FIS, with a deep focus on, and expertise in, alternative investments. “As Alternative fund managers and investors across Europe continue to embrace technology – and data – as a competitive weapon to drive future accelerated growth, we’re putting our resources in some of the largest markets. Our London office will be a critical hub for our workings in the UK, expanding upon our other offices in Silicon Valley, New York, Austin, Rome and Pune, India,” said Haresh Patel CEO of Mercatus. “We will continue to expand our local presence across Europe and Asia as our customers have deal and asset management teams in 118 countries with $540B AUM operating within the Mercatu

LivaNova Combats Leg Ischemia with Breakthrough Bidirectional Cannula16.7.2019 13:00:00 CESTPress release

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today launched its innovative arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery. LivaNova Bi-Flow received CE Mark earlier this year and is the only bidirectional arterial cannula designed to prevent leg ischemia during cardiac surgery procedures requiring femoral artery cannulation. In a clinical study, Bi-Flow was easily inserted and removed without complications and was proven to provide simultaneous systemic and distal perfusion of the limb in a safe and reproducible way.1 Leg ischemia is caused by compromised blood flow to a lower limb and can affect up to 11% of patients undergoing complex cardiac surgery procedures.2 Consequences can include higher mortality, higher morbidity and longer hospital stays.3 The first procedure in Europe using a Bi-Flow cannula was performed by Patrick Perier M.D., FACS, at the Cardiovascular Center of Bad Neustadt, Germany. “I truly bel