Immunocore Holdings Limited
Immunocore receives optimistic CHMP opinion for KIMMTRAK® (tebentafusp) for the remedy of unresectable or metastatic uveal melanoma
If accepted by the European Medicines Agency, KIMMTRAK would be the first and solely remedy possibility accepted in Europe to deal with sufferers with unresectable or metastatic uveal melanoma
KIMMTRAK demonstrated statistically and clinically significant total survival (OS) profit, hazard ratio of 0.51, with median OS of just about 22 months
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 25 February 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology firm pioneering the event of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to deal with a broad vary of ailments, together with most cancers, autoimmune and infectious ailments as we speak proclaims that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a optimistic opinion recommending the approval of KIMMTRAK® (tebentafusp) for the remedy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM).
The CHMP optimistic opinion is among the last steps earlier than advertising and marketing authorization is granted by the EMA, which has the authority to approve medicines to be used all through the European Union. If accepted, KIMMTRAK® can be the primary T cell receptor remedy commercially obtainable in Europe. Immunocore’s Marketing Authorisation Application was reviewed beneath EMA’s accelerated evaluation process, which is given if the CHMP determines the remedy is of main curiosity from a public well being perspective and represents a therapeutic innovation.
“The CHMP’s advice of KIMMTRAK brings us nearer to offering a much-needed remedy choice to sufferers in Europe,” mentioned Bahija Jallal, Chief Executive Officer of Immunocore. “This 12 months, tons of of individuals throughout the EU will likely be identified with metastatic uveal melanoma. Left with minimal-to-no choices, these sufferers have a devastating prognosis. KIMMTRAK is the primary remedy to show a survival profit in sufferers with this illness, offering new hope to those people and to the medical doctors treating them.”
The advice comes only one month after regulatory approval of KIMMTRAK by the United States Food and Drug Administration (FDA) final month (January 25), making it the primary and now solely remedy for the remedy of unresectable or metastatic uveal melanoma to be accepted by the FDA.
The CHMP advice of KIMMTRAK is predicated on the outcomes of Immunocore’s Phase 3 IMCgp100-202 scientific trial, which have been revealed within the September 23, 2021 difficulty of the New England Journal of Medicine. The randomized pivotal trial evaluated total survival (OS) of KIMMTRAK in comparison with investigator’s alternative (both pembrolizumab, ipilimumab, or dacarbazine) in sufferers with beforehand untreated mUM. 378 sufferers have been randomized in a 2:1 ratio to both KIMMTRAK or investigator’s alternative. Data from the trial, the biggest Phase 3 trial undertaken in mUM, confirmed that KIMMTRAK demonstrated unprecedented median OS profit as a first-line remedy. The OS Hazard Ratio (HR) within the intent-to-treat inhabitants favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s alternative (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the scientific trials, throughout each arms, sufferers stopped remedy for illness development, until the affected person was in any other case deriving profit, or for unacceptable toxicity.1
Dr. Paul Nathan, uveal melanoma lead for the European Organisation for Research and Treatment of Cancer, mentioned: “Metastatic uveal melanoma has traditionally been related to a very poor prognosis and, up till now, has been refractory to most therapies. KIMMTRAK represents a big new type of remedy, providing the prospect at an extended life for sufferers with the illness, and with it, hope.”
In the randomised Phase 3 trial of KIMMTRAK (tebentafusp), treatment-related antagonistic reactions have been manageable and according to the proposed mechanism of motion. Among the sufferers handled with KIMMTRAK, the commonest Grade 3 or larger antagonistic occasions have been rash (18%), pyrexia (4%), and pruritus (5%). In the 245 sufferers handled with KIMMTRAK, Grade 3 cytokine launch syndrome (CRS) occurred in <1% of sufferers and have been typically well-managed. There have been no Grade 4 CRS occasions noticed within the Phase 3 scientific trial.
The United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have every accepted the submission of the Company’s Marketing Authorisation Application. In April of 2021, Immunocore launched a worldwide early entry program to make KIMMTRAK available to mUM sufferers. The Company is targeted on persevering with to deal with these sufferers with KIMMTRAK as regulatory approval is sought within the EU and the person EU Member States. There are at present over 200 sufferers within the early entry program.
About Uveal Melanoma
Uveal melanoma is a uncommon and aggressive type of melanoma, which impacts the attention. Although it’s the commonest main intraocular malignancy in adults, the prognosis is uncommon, and as much as 50% of individuals with uveal melanoma will finally develop metastatic illness. Unresectable or metastatic uveal melanoma sometimes has a poor prognosis and had no accepted remedy till KIMMTRAK.
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector perform. KIMMTRAK particularly targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the primary molecule developed utilizing Immunocore’s ImmTAC know-how platform designed to redirect and activate T cells to acknowledge and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA within the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation beneath the UK Early Access to Medicines Scheme for metastatic uveal melanoma.
About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated total survival (OS) of KIMMTRAK (tebentafusp-tebn) in comparison with investigator’s alternative (both pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive grownup sufferers with beforehand untreated mUM. KIMMTRAK demonstrated an unprecedented OS profit with a Hazard Ratio (HR) within the intent-to-treat inhabitants favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s alternative (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
IMPORTANT U.S. SAFETY INFORMATION Regarding FDA Approval
Cytokine Release Syndrome (CRS), which can be severe or life-threatening, occurred in sufferers receiving KIMMTRAK. Monitor for at the least 16 hours following first three infusions after which as clinically indicated. Manifestations of CRS might embrace fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of sufferers who obtained KIMMTRAK with 0.8% being grade 3 or 4. Ensure rapid entry to medicines and resuscitative gear to handle CRS. Ensure sufferers are euvolemic previous to initiating the infusions. Closely monitor sufferers for indicators or signs of CRS following infusions of KIMMTRAK. Monitor fluid standing, important indicators, and oxygenation degree and supply applicable remedy. Withhold or discontinue KIMMTRAK relying on persistence and severity of CRS.
Skin reactions, together with rash, pruritus, and cutaneous edema occurred in 91% of sufferers handled with KIMMTRAK. Monitor sufferers for pores and skin reactions. If pores and skin reactions happen, deal with with antihistamine and topical or systemic steroids primarily based on persistence and severity of signs. Withhold or completely discontinue KIMMTRAK relying on the severity of pores and skin reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of sufferers handled with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and complete blood bilirubin previous to the beginning of and through remedy with KIMMTRAK. Withhold KIMMTRAK in keeping with severity.
KIMMTRAK might trigger fetal hurt. Advise pregnant sufferers of potential threat to the fetus and sufferers of reproductive potential to make use of efficient contraception throughout remedy with KIMMTRAK and 1 week after the final dose.
The most typical antagonistic reactions (≥30%) in sufferers who obtained KIMMTRAK have been cytokine launch syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, belly ache, edema, hypotension, dry pores and skin, headache, and vomiting. The most typical (≥50%) laboratory abnormalities have been decreased lymphocyte depend, elevated creatinine, elevated glucose, elevated AST, elevated ALT, decreased hemoglobin, and decreased phosphate.
Please see full Prescribing Information, together with BOXED WARNING for CRS.
About ImmTAC® Molecules
Immunocore’s proprietary T cell receptor (TCR) know-how generates a novel class of bispecific biologics known as ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules which are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular most cancers antigens with ultra-high affinity and selectively kill these most cancers cells through an anti-CD3 immune-activating effector perform. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of motion holds the potential to deal with hematologic and stable tumours, no matter mutational burden or immune infiltration, together with immune “chilly” low mutation charge tumours.
Immunocore is a commercial-stage biotechnology firm pioneering the event of a novel class of TCR bispecific immunotherapies known as ImmTAX – Immune mobilizing monoclonal TCRs Against X illness – designed to deal with a broad vary of ailments, together with most cancers, autoimmune, and infectious illness. Leveraging its proprietary, versatile, off-the-shelf ImmTAX platform, Immunocore is growing a deep pipeline in a number of therapeutic areas, together with 5 scientific stage applications in oncology and infectious illness, superior pre-clinical applications in autoimmune illness and a number of earlier pre-clinical applications. Immunocore’s most superior oncology TCR therapeutic, KIMMTRAK (tebentafusp-tebn), has been accepted by the U.S. FDA for the remedy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM) having demonstrated an total survival profit in a randomized Phase 3 scientific trial in metastatic uveal melanoma, a most cancers that has traditionally confirmed to be insensitive to different immunotherapies.
1Nathan P., et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021; 385:1196-1206.
Forward Looking Statements
This press launch accommodates “forward-looking statements” inside the that means of the protected harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, aside from statements of historic details, included on this press launch are forward-looking statements. These statements embrace, however aren’t restricted to, statements relating to the European Commission’s last choice on Immunocore’s Marketing Authorisation Application and approval of KIMMTRAK within the European Union; advertising and marketing and therapeutic potential of KIMMTRAK for metastatic uveal melanoma (mUM); the anticipated scientific advantages of KIMMTRAK together with prolonged total survival profit; expectations relating to the power to succeed in sufferers in a well timed method together with receiving future regulatory approval in respective European international locations, the United Kingdom, Australia and Canada; the worth proposition of KIMMTRAK in mUM and profit as an orphan indication together with expectations relating to the potential market measurement alternative; Immunocore’s gross sales and advertising and marketing plans within the United States and the European Union; and future growth plans of tebentafusp, together with the timing or chance of growth into further markets or geographies. Any forward-looking statements are primarily based on administration’s present expectations of future occasions and are topic to a lot of dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements, a lot of that are past the Company’s management. These dangers and uncertainties embrace, however aren’t restricted to, the affect of the continued COVID-19 pandemic and the Omicron variant on the Company’s enterprise, technique scientific trials and monetary place; Immunocore’s skill to keep up regulatory approval of KIMMTRAK; its skill to execute its commercialization technique for KIMMTRAK; its skill to develop, manufacture and commercialize its different product candidates together with plans for future growth of tebentafusp and different product candidates, together with the timing or chance of growth into further markets or geographies; business provide of KIMMTRAK or any future accepted merchandise, and launching, advertising and marketing and promoting of KIMMTRAK or any future accepted merchandise; Immunocore’s skill and plans in persevering with to ascertain and increase a business infrastructure and to efficiently launch, market and promote KIMMTRAK; actions of regulatory businesses, which can have an effect on the initiation, timing and progress of scientific trials or future regulatory approval; Immunocore’s skill to acquire, keep and implement mental property safety for KIMMTRAK or any product candidates it’s growing; surprising security or efficacy information noticed throughout preclinical research or scientific trials; scientific trial web site activation or enrollment charges which are decrease than anticipated; modifications in anticipated or current competitors; Immunocore’s skill to acquire, keep and implement mental property safety for KIMMTRAK or any product candidates it’s growing; and the success of Immunocore’s present and future collaborations, partnerships or licensing preparations. These and different dangers and uncertainties are described in higher element within the part titled “Risk Factors” in Immunocore’s filings with the Securities and Exchange Commission, together with Immunocore’s most up-to-date Annual Report on Form 20-F for the 12 months ended December 31, 2020 filed with the Securities and Exchange Commission on March 25, 2021, in addition to discussions of potential dangers, uncertainties, and different vital components within the Company’s subsequent filings with the Securities and Exchange Commission. All info on this press launch is as of the date of the discharge, and the Company undertakes no responsibility to replace this info, besides as required by regulation.
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