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This article, adapted from CytoCaresImmunocore, pioneered the development of a novel class of T-cell receptor (TCR) bispecific immunotherapies for the treatment of a variety of diseases including cancer, infectious diseases and autoimmune diseases
.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Kimmtrak (tebentafusp-tebn, IMCgp100): for the treatment of HLA-A*02:01 positive unresectable or metastatic uveal melanoma (mUM) adult patients
.
It is worth mentioning that the approval of Kimmtrak has created many firsts: (1) the first TCR therapy to receive FDA regulatory approval; (2) the first FDA regulatory approval to receive bispecific T cell engagement for the treatment of solid tumors (3) the first and only FDA-approved therapy for unresectable or metastatic mUM
.
Uveal melanoma (UM) is a highly aggressive and devastating disease with poor survival rates, which has historically resulted in the death of many patients within a year of metastases
.
The prognosis for patients with metastatic disease is poor, and the situation has not improved significantly in decades
.
The approval of Kimmtrak represents a major paradigm change in the treatment of metastatic uveal melanoma (mUC) and brings hope for the first time to patients with these aggressive cancers
.
In a Phase 3 clinical trial, Kimmtrak treatment demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit: a 49% reduction in the risk of death (HR=0.
51) compared to the investigator's chosen regimen, with a median OS nearly 22 months
.
The active pharmaceutical ingredient of Kimmtrak is tebentafusp, a novel bispecific protein composed of a soluble TCR fused to an anti-CD3 immune effector domain
.
tebentafusp was designed to specifically target gp100, a lineage antigen expressed in melanocytes and melanoma
.
Tebentafusp is the first molecule developed using Immucore's ImmTAC technology platform and is designed to redirect and activate T cells to recognize and kill tumor cells
.
Previously, tebentafusp has been granted Breakthrough Drug Designation (BTD), Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the US FDA for the treatment of metastatic uveal melanoma (mUM), and has been granted early access medicine designation (EAMS) in the UK ) was awarded Breakthrough Innovative Medicine (PIM)
.
Uveal melanoma (Image source: springernature.
com) The US FDA approved Kimmtrak based on robust efficacy data from the randomized Phase 3 IMCgp100-202 clinical trial (NCT03070392)
.
The trial evaluated the efficacy and safety of tebentafusp as monotherapy in previously untreated (treatment-naive) patients with mUM
.
A total of 378 patients were randomized 2:1 to either tebentafusp (study group) or the investigator's choice of treatment (control group)
.
In this study, the treatment options selected by the investigators include: dacarbazine, anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab), anti-PD-1 therapy Keytruda (Kreida, generic name: pembrolizumab, paclitaxel) bolizumab)
.
The primary endpoint of the study was overall survival (OS)
.
In the final analysis of the trial, the study met its primary efficacy endpoint: tebentafusp monotherapy compared with investigator-selected regimens (82% Keytruda, 12% Yervoy, 6% dacarbazine) in clinical and Statistically significant survival advantage was demonstrated: significantly prolonged overall survival (OS) and reduced risk of death by 49% (HR = 0.
51 [95% CI: 0.
37-0.
71]; p < 0.
0001)
.
One-year overall survival was 73.
2% in the tebentafusp group and 58.
5% in the investigator-selected regimen
.
In addition, tebentafusp treatment significantly reduced the risk of disease progression or death (PFS) by 27% (HR=0.
73) compared with the investigator-selected regimen
.
In this study, treatment-related adverse events were manageable and consistent with the proposed mechanism of action
.
Phase 2 and 3 clinical data of tebentafusp in mUM (click image to see larger image) Immunocore's core technology is ImmTAC (anti-tumor immune agonist monoclonal T cell receptor), a novel bispecific biomacromolecule , consisting of engineered T cell receptors (TCRs) and anti-CD3 scFvs, of which: The engineered TCRs can specifically recognize and bind to the surface of tumor cells with significantly improved affinity (9 times higher than antigen-antibody affinity) The antigenic peptide-human leukocyte antigen complex (pHLA), anti-CD30 scFv can attract and recruit T cells to the surrounding tumor cells and activate T cells to play a tumor-killing role
.
ImmTAC is designed to overcome the limitations of other immuno-oncology drugs by combining the TCR system and anti-CD3 effector functions to activate highly specific T cell responses against cancer cells
.
With ImmTAC technology, Immunocore has reached extensive immuno-oncology collaborations with several pharmaceutical giants including Roche, GlaxoSmithKline, Eli Lilly and AstraZeneca
.
The molecular structure of ImmTAX (click the image to view the larger image) tebentafusp is the fastest clinically advanced ImmTAC, designed to specifically target the melanoma-associated antigen gp100 and enable T cells to directly target cancer cells to generate a potent and specific response
.
Uveal melanoma (UM) is an aggressive melanoma that arises from melanocytes in the uveal area of the eye
.
Survival rates for UM have remained largely unchanged since the 1970s, with metastatic UM having the greatest disease burden
.
Prior to the approval of tebentafusp, there was no proven standard of care for metastatic UM; in addition, various therapies, including checkpoint inhibitors, were used without clear evidence of benefit in this patient population
.
Original source: Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Kimmtrak (tebentafusp-tebn, IMCgp100): for the treatment of HLA-A*02:01 positive unresectable or metastatic uveal melanoma (mUM) adult patients
.
It is worth mentioning that the approval of Kimmtrak has created many firsts: (1) the first TCR therapy to receive FDA regulatory approval; (2) the first FDA regulatory approval to receive bispecific T cell engagement for the treatment of solid tumors (3) the first and only FDA-approved therapy for unresectable or metastatic mUM
.
Uveal melanoma (UM) is a highly aggressive and devastating disease with poor survival rates, which has historically resulted in the death of many patients within a year of metastases
.
The prognosis for patients with metastatic disease is poor, and the situation has not improved significantly in decades
.
The approval of Kimmtrak represents a major paradigm change in the treatment of metastatic uveal melanoma (mUC) and brings hope for the first time to patients with these aggressive cancers
.
In a Phase 3 clinical trial, Kimmtrak treatment demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit: a 49% reduction in the risk of death (HR=0.
51) compared to the investigator's chosen regimen, with a median OS nearly 22 months
.
The active pharmaceutical ingredient of Kimmtrak is tebentafusp, a novel bispecific protein composed of a soluble TCR fused to an anti-CD3 immune effector domain
.
tebentafusp was designed to specifically target gp100, a lineage antigen expressed in melanocytes and melanoma
.
Tebentafusp is the first molecule developed using Immucore's ImmTAC technology platform and is designed to redirect and activate T cells to recognize and kill tumor cells
.
Previously, tebentafusp has been granted Breakthrough Drug Designation (BTD), Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the US FDA for the treatment of metastatic uveal melanoma (mUM), and has been granted early access medicine designation (EAMS) in the UK ) was awarded Breakthrough Innovative Medicine (PIM)
.
Uveal melanoma (Image source: springernature.
com) The US FDA approved Kimmtrak based on robust efficacy data from the randomized Phase 3 IMCgp100-202 clinical trial (NCT03070392)
.
The trial evaluated the efficacy and safety of tebentafusp as monotherapy in previously untreated (treatment-naive) patients with mUM
.
A total of 378 patients were randomized 2:1 to either tebentafusp (study group) or the investigator's choice of treatment (control group)
.
In this study, the treatment options selected by the investigators include: dacarbazine, anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab), anti-PD-1 therapy Keytruda (Kreida, generic name: pembrolizumab, paclitaxel) bolizumab)
.
The primary endpoint of the study was overall survival (OS)
.
In the final analysis of the trial, the study met its primary efficacy endpoint: tebentafusp monotherapy compared with investigator-selected regimens (82% Keytruda, 12% Yervoy, 6% dacarbazine) in clinical and Statistically significant survival advantage was demonstrated: significantly prolonged overall survival (OS) and reduced risk of death by 49% (HR = 0.
51 [95% CI: 0.
37-0.
71]; p < 0.
0001)
.
One-year overall survival was 73.
2% in the tebentafusp group and 58.
5% in the investigator-selected regimen
.
In addition, tebentafusp treatment significantly reduced the risk of disease progression or death (PFS) by 27% (HR=0.
73) compared with the investigator-selected regimen
.
In this study, treatment-related adverse events were manageable and consistent with the proposed mechanism of action
.
Phase 2 and 3 clinical data of tebentafusp in mUM (click image to see larger image) Immunocore's core technology is ImmTAC (anti-tumor immune agonist monoclonal T cell receptor), a novel bispecific biomacromolecule , consisting of engineered T cell receptors (TCRs) and anti-CD3 scFvs, of which: The engineered TCRs can specifically recognize and bind to the surface of tumor cells with significantly improved affinity (9 times higher than antigen-antibody affinity) The antigenic peptide-human leukocyte antigen complex (pHLA), anti-CD30 scFv can attract and recruit T cells to the surrounding tumor cells and activate T cells to play a tumor-killing role
.
ImmTAC is designed to overcome the limitations of other immuno-oncology drugs by combining the TCR system and anti-CD3 effector functions to activate highly specific T cell responses against cancer cells
.
With ImmTAC technology, Immunocore has reached extensive immuno-oncology collaborations with several pharmaceutical giants including Roche, GlaxoSmithKline, Eli Lilly and AstraZeneca
.
The molecular structure of ImmTAX (click the image to view the larger image) tebentafusp is the fastest clinically advanced ImmTAC, designed to specifically target the melanoma-associated antigen gp100 and enable T cells to directly target cancer cells to generate a potent and specific response
.
Uveal melanoma (UM) is an aggressive melanoma that arises from melanocytes in the uveal area of the eye
.
Survival rates for UM have remained largely unchanged since the 1970s, with metastatic UM having the greatest disease burden
.
Prior to the approval of tebentafusp, there was no proven standard of care for metastatic UM; in addition, various therapies, including checkpoint inhibitors, were used without clear evidence of benefit in this patient population
.
Original source: Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
