Tebentafusp is the first investigational therapy to improve Overall Survival (OS) in patients with metastatic uveal melanoma
First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor
OXFORDSHIRE, UK & CONSHOHOCKEN, PA & ROCKVILLE, MD, USA I April 12, 2021 IImmunocore (Nasdaq: IMCR), a late-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 and autoimmune disease, presented data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) in the clinical trial plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021.
Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.
“This is the first investigational therapy to demonstrate improved OS in metastatic uveal melanoma,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We believe these data demonstrate that tebentafusp has the potential to provide a meaningful difference in the treatment of metastatic uveal melanoma, a highly aggressive disease for which there is no effective standard of care.”
In a separate oral presentation on Monday April 12, Marcus O. Butler shared an analysis of previously treated uveal melanoma patients who had prolonged survival.
Two posters from the phase 2 IMCgp100-102 study are also available for on-demand viewing at the AACR website. These analyses investigated the proposed mechanism of action (MoA), including inducing an increase in cytokines and T cell trafficking into the tumor.
Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021.
The Company will host a conference call for industry, health and investment professionals on Tuesday, April 13th at 7:30 am ET to discuss the phase 3 IMCgp100-202 trial. The webcast can be accessed directly through this link. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Investor Relations section of the Company’s website for at least 90 days.
PLENARY AND ORAL PRESENTATIONS
Title: Phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma
- Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am – 1:30pm ET
- Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
- Abstract #: 5342
- Session Title: Phase III Clinical Trials
Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival
- Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
- Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
- Abstract #: 5338
- Session Title: Disease-Oriented Innovative Clinical Research and Trials
POSTER PRESENTATIONS
Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells
- Poster #: 517
- Presenter: Marcus O. Butler (PI)
Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp
- Poster #: 1673
- Presenter: Jessica Hassel (PI)
About Immunocore
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore’s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.
About ImmTAC® Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise 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 tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumours.
About Tebentafusp
Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.
SOURCE: Immunocore
Post Views: 163
Tebentafusp is the first investigational therapy to improve Overall Survival (OS) in patients with metastatic uveal melanoma
First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor
OXFORDSHIRE, UK & CONSHOHOCKEN, PA & ROCKVILLE, MD, USA I April 12, 2021 IImmunocore (Nasdaq: IMCR), a late-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 and autoimmune disease, presented data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) in the clinical trial plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021.
Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.
“This is the first investigational therapy to demonstrate improved OS in metastatic uveal melanoma,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We believe these data demonstrate that tebentafusp has the potential to provide a meaningful difference in the treatment of metastatic uveal melanoma, a highly aggressive disease for which there is no effective standard of care.”
In a separate oral presentation on Monday April 12, Marcus O. Butler shared an analysis of previously treated uveal melanoma patients who had prolonged survival.
Two posters from the phase 2 IMCgp100-102 study are also available for on-demand viewing at the AACR website. These analyses investigated the proposed mechanism of action (MoA), including inducing an increase in cytokines and T cell trafficking into the tumor.
Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021.
The Company will host a conference call for industry, health and investment professionals on Tuesday, April 13th at 7:30 am ET to discuss the phase 3 IMCgp100-202 trial. The webcast can be accessed directly through this link. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Investor Relations section of the Company’s website for at least 90 days.
PLENARY AND ORAL PRESENTATIONS
Title: Phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma
- Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am – 1:30pm ET
- Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
- Abstract #: 5342
- Session Title: Phase III Clinical Trials
Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival
- Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
- Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
- Abstract #: 5338
- Session Title: Disease-Oriented Innovative Clinical Research and Trials
POSTER PRESENTATIONS
Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells
- Poster #: 517
- Presenter: Marcus O. Butler (PI)
Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp
- Poster #: 1673
- Presenter: Jessica Hassel (PI)
About Immunocore
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore’s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.
About ImmTAC® Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise 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 tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumours.
About Tebentafusp
Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.
SOURCE: Immunocore
Post Views: 163
