Immunocore announces upcoming presentation and posters at ESMO 2023
Long-term survival data for KIMMTRAK in previously untreated patients with metastatic uveal melanoma to be presented as a late-breaking abstract in a mini oral session
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md, 07 October 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, will present three-year Phase 3 survival data for KIMMTRAK in metastatic uveal melanoma at the European Society for Medical Oncology (ESMO) Congress 2023 commencing on 20 October.
In addition to the oral presentation, the company will present three posters sharing data on the effect of subsequent therapies, including checkpoint inhibitors, on overall survival from KIMMTRAK treatment for metastatic uveal melanoma; the reprogramming effect of KIMMTRAK on immunosuppressive M2 macrophages; and the lack of impact of BRAF mutation on KIMMTRAK treatment in advanced cutaneous melanoma.
Presentation and poster details
Title: Three-year survival with tebentafusp in previously untreated metastatic uveal melanoma in a phase 3 trial (LBA50)
Presenting author: Sophie Piperno-Neumann
Session: Mini oral session – Melanoma and other skin tumours, Saturday 21 October, 2023
Title: Tebentafusp reprograms immunosuppressive tumor-associated M2 macrophages towards anti-tumoral M1 macrophages (2238P)
Presenting author: Josep M. Piulats
Session: Poster display, Saturday 21 October, 2023
Title: BRAF mutation status does not impact outcomes with tebentafusp in advanced cutaneous melanoma
Presenting author: Alexander N. Shoushtari
Session: Poster display, Sunday 22 October, 2023
Title: Effect of subsequent therapies including checkpoint inhibitors on overall survival in a phase 3 randomized trial of tebentafusp in first line metastatic uveal melanoma: long-term follow up
Presenting author: Marlana Orloff
Session: Poster display, Sunday 22 October, 2023
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About ImmTAC® molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize 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 tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.
About KIMMTRAK®
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
About Phase 3 IMCgp100-202 Trial
IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “can,” “will,” “believe,” “expect,” “plan,” “anticipate,” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the therapeutic potential and expected clinical benefits of our product candidates, including overall survival benefit; expectations regarding the effect of tebentafusp on immunosuppressive M2 macrophages; expectations indicating the lack of impact of BRAF mutation on tebentafusp treatment in advanced cutaneous melanoma. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond Immunocore’s control.
These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on Immunocore’s business, strategy, financial position and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates, or commercial supply of KIMMTRAK or any future approved products, including as a result of the COVID-19 pandemic, war in Ukraine or global geopolitical tension; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during pre-clinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of Immunocore’s clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the COVID-19 pandemic, war in Ukraine and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any product candidates it is developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 1, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Immunocore’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Immunocore undertakes no duty to update this information, except as required by law.
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