First major breakthrough in 40 years! New TCR therapy tebentafusp treatment of vine melanoma (UM) Phase 3 clinical significantly extended survival!

November 23, 2020 // -- Immunocore is a late-stage clinical biotechnology company that pioneered the development of a new class of T-cell-specific immunotherapy for a wide range of diseases, including cancer, infectious diseases and autoimmune diseases.
recently, the company announced positive results in phase 3 IMCgp100-202 clinical trial (NCT03070392) in the treatment of metastasis grape membrane melanoma (mUM) in the study of TCR therapy tebentafusp (IMCgp100).
data show that the study reached its main endpoint: tebentafusp therapy showed strong therapies and significantly extended total survival (OS) compared to the treatment options chosen by the researchers.
note that this is the first Phase 3 clinical trial of any TCR therapy to achieve positive results and the first phase 3 clinical trial of any dual-specific therapy in solid tumors.
mUM patients had poor prognostication and had not changed significantly for decades.
approved, tebentafusp would be the first new treatment to improve OS in mUM patients in 40 years.
tebentafusp is a new type of dual-specific protein, which is composed of soluble TCR and anti-CD3 immuno-effector domain.
tebentafusp is designed to specifically target gp100, a genealogy antigen expressed in melanin cells and melanoma.
is the first molecule developed using Immucore's ImTAC technology platform to redirect and activate T cells to identify and kill tumor cells.
addition, the FDA has granted tebentafusp orphan drug eligibility (ODD) and fast-track (FTD) for the treatment of vine melanoma (UM).
IMCgp100-202 study was conducted in patients with (primary) mUM who had not been treated in the past, a total of 378 patients were randomly assigned to tebentafusp or the treatment options chosen by the researchers on a 2:1 scale.
the study, the researchers selected treatment options that included: dacabazine, anti-CTLA-4 therapy Yeervoy (ipilimumab, ipliplumma), anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pabliju monoanti).
end point of this study is total lifetime (OS).
results show that in the first pre-planned interim analysis, based on the assessment of the Independent Data Monitoring Board (IDMC), the study reached a predefined boundary of statistically significant total lifetime (OS) end points.
in the intentional therapy (ITT) population, the risk of OS is better than that of (HR) compared to the treatment options selected by the researchers (82% dakabazine, 12% Yervoy, 6% Keytruda) tebentafusp (HR-0.51; 95% CI: 0.36-0.71; p<0.0001), equivalent to a 49% reduction in risk of death.
although OS data are premature, Kaplan-Meier predicts a one-year survival rate of 73 percent for the tebentafusp treatment group and 58 percent for the control group.
these efficacy data confirm promising OS data observed in phase 2 IMCgp100-102 studies conducted in patients with previously treated (treated) mUM.
," said Bahija Jallal, chief executive of Immunocore.com, which has a low survival rate and is in dire need of new treatments.
the positive survival benefits of tebentafusp represent an important step towards bringing a potentially innovative therapy to a group of MUM patients with highly unsoolved medical needs.
approved, tebentafusp would be the first new treatment in 40 years to improve total survival (OS).
look forward to sharing this data with the healthcare industry and regulators in the near future.
", said David Berman, head of research and development at Immunocore, "To our knowledge, this is the first positive Phase 3 study of any TCR therapy to demonstrate survival benefits, and the first positive Phase 3 study of any dual-specific therapy to demonstrate survival benefits in solid tumors."
The survival benefits observed in this randomized Phase 3 clinical trial of checkpoint inhibitors have validated the effectiveness of our ImTAC platform, and we are currently expanding our research on other types of cancer where medical needs have not yet been met.
grape membrane melanoma (UM) is one of the types of tumors with the lowest tumor mutation burden (TMB), these results show that our ImTAC platform should be evaluated in tumors with low or high TMB status.
"ImmTAC molecular structure (Photo: Immunocore Website) Immunocore's core technology is ImTAC (anti-tumor immuno-excited monoclonal T-cell subject), a new type of dual-specific biological large molecule consisting of engineered T-cells (TCR) and anti-CD3 scFv, where: The modified TCR specifically identifies and binds to the antigen peptide-human le white blood cell antigen complex (pHLA) on the surface of the tumor cell with a significantly improved affinity (9 times higher than the antigen antibody affinity), while the anti-CD30 scFv attracts, recruits and activates T cells around the tumor cell to act as tumor killer.
ImTAC aims to overcome the limitations of other immuno-oncology drugs by combining TCR systems and anti-CD3 effector functions to activate highly effective, specific T-cell responses to cancer cells.
with ImTAC technology, Immunocore has reached extensive immuno-oncology partnerships with pharmaceutical giants including Roche, GlaxoSmithKline, Lilly and AstraZeneta.
tebentafusp is one of the fastest clinically advanced ImTACs, designed to specifically target melanoma-related antigen gp100 and enable T-cells to respond strongly and specifically to cancer cells directly.
currently, tebentafusp treatment of vine melanoma (UM) is in Phase 3 clinical.
grape melanoma (UM) is an invasive melanoma that originates in melanin cells in the grape membrane region of the eye.
since the 1970s, the survival rate of UM has remained basically the same, with the greatest burden of disease on metastasis UM.
currently, there is no proven standard of treatment for metastasis UM, and various therapies, including checkpoint inhibitors, are used in cases where there is no clear evidence of benefit to this group of patients.
origin of the original text: Immunocore's tebentafusp provs superior survival survival compared to investigator's choice in a Phase 3 clinical trial of patients with patients with previously untre metaatedstatic uveal melanoma<!--/ewebeditor:page->