Immunocore presents KIMMTRAK clinical data
demonstrating that patients with stable disease and confirmed tumor
reduction have similar clinical outcomes to patients with partial
response
Data were presented at ASCO 2024, where
Immunocore also presented Phase 1 data from its PRAME trial with
brenetafusp (IMC-F106C) in advanced cutaneous melanoma
(OXFORDSHIRE, England & CONSHOHOCKEN, PA
& ROCKVILLE, MD, US, June 1, 2024) Immunocore Holdings plc
(Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage
biotechnology company pioneering and delivering transformative
immunomodulating medicines to radically improve outcomes for
patients with cancer, infectious diseases and autoimmune diseases,
today presented three posters about KIMMTRAK® (tebentafusp-tebn)
for the treatment of patients with unresectable or metastatic uveal
melanoma (mUM) at the 2024 ASCO (American Society for Clinical
Oncology) Annual Meeting. These data showed that treatment benefit
for patients with stable disease and any confirmed tumor reduction
was similar to patients with partial response.
“In both Phase 2 and Phase 3 KIMMTRAK trials,
patients with stable disease and durable tumor reduction,
regardless of depth, had similar benefit as patients with RECIST
partial response,” said Mohammed Dar, Senior Vice
President, Clinical Development, and Chief Medical Officer,
Immunocore. “The data presented at ASCO builds upon the
mounting evidence confirming that disease control is the best early
radiographic measure of clinical benefit across our ImmTAC
platform.”
“KIMMTRAK is now the standard of care, in
launched countries, for HLA-A*02:01-positive patients with
metastatic or unresectable uveal melanoma,” said Ralph
Torbay, Immunocore’s Chief Commercial Officer. “Physicians
can now leverage these data, presented at ASCO today, to positively
inform their conversations with patients who have stable disease
and minor reductions in tumor size.”
Of the 127 patients treated with KIMMTRAK in the
Phase 2 trial (IMCgp100-102), 25% (32/127) had any tumor reduction
that was confirmed in at least one subsequent scan, including 6
partial responses (PR), an overall response rate of 5%, and 20%
(26/127) stable disease (SD). The clinical outcomes in the 26
patients with SD were similar to the 6 PR patients, including
durable duration of tumor reduction or response, ctDNA molecular
response, and overall survival. In the Phase 3 trial
(IMCgp100-202), KIMMTRAK-treated patients with SD who had any
confirmed tumor reduction had durability of tumor reduction of 11
months, which was the same as the durability of response for
patients with RECIST PR or CR.
Full poster details:
Stable disease with confirmed tumor reduction
has a similar clinical outcome as RECIST partial response for
tebentafusp in metastatic uveal melanomaPresenting author:
Alexandra Ikeguchi
Association between clinical and disease
characteristics and detectable or undetectable baseline ctDNA in
patients with metastatic uveal melanomaPresenting author: Paul
Nathan
Baseline and serial ctDNA dynamics predicts
outcomes in patients treated with first-line tebentafusp including
those who were and were not treated beyond progressionPresenting
author: Ryan Sullivan
###
About Immunocore
Immunocore is a commercial-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, autoimmune, and infectious disease.
Leveraging its proprietary, flexible, off-the-shelf ImmTAX
platform, Immunocore is developing a deep pipeline in multiple
therapeutic areas, including nine active clinical and pre-clinical
programs in oncology, infectious diseases, and autoimmune
diseases. The Company’s most advanced oncology TCR therapeutic,
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 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
2 IMCgp100-102 Trial
IMCgp100-102 (NCT02570308) was an
open-label, multi-center, single-arm trial of the safety and
efficacy of tebentafusp in patients with previously treated mUM.
The trial included 127 HLA-A*02:01+ 2L+ mUM patients, treated with
tebentafusp at the recommended Phase 2 dose of 68mcg following
intra-patient dose escalation of 20 mcg (week 1) and 30 mcg (week
2). The primary endpoint was objective response rate by blinded
independent central review, with secondary objectives being overall
survival (OS) and safety in 127 patients who had enrolled after
progressing on one or more prior therapies.
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).
IMPORTANT SAFETY
INFORMATION
Cytokine Release Syndrome (CRS), which
may be serious or life-threatening, occurred in patients receiving
KIMMTRAK. Monitor for at least 16 hours following first three
infusions and then as clinically indicated. Manifestations
of CRS may include fever, hypotension, hypoxia, chills, nausea,
vomiting, rash, elevated transaminases, fatigue, and headache. CRS
occurred in 89% of patients who received KIMMTRAK with 0.8% being
grade 3 or 4. Ensure immediate access to medications and
resuscitative equipment to manage CRS. Ensure patients are
euvolemic prior to initiating the infusions. Closely monitor
patients for signs or symptoms of CRS following infusions of
KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level
and provide appropriate therapy. Withhold or discontinue KIMMTRAK
depending on persistence and severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and
cutaneous edema occurred in 91% of patients treated with KIMMTRAK.
Monitor patients for skin reactions. If skin reactions occur, treat
with antihistamine and topical or systemic steroids based on
persistence and severity of symptoms. Withhold or permanently
discontinue KIMMTRAK depending on the severity of skin
reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of
patients treated with KIMMTRAK. Monitor alanine aminotransferase
(ALT), aspartate aminotransferase (AST), and total blood bilirubin
prior to the start of and during treatment with KIMMTRAK. Withhold
KIMMTRAK according to severity.
Embryo-Fetal Toxicity
KIMMTRAK may cause fetal harm. Advise pregnant
patients of potential risk to the fetus and patients of
reproductive potential to use effective contraception during
treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in
patients who received KIMMTRAK were cytokine release syndrome,
rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain,
edema, hypotension, dry skin, headache, and vomiting. The most
common (≥50%) laboratory abnormalities were decreased lymphocyte
count, increased creatinine, increased glucose, increased AST,
increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of
Product Characteristics (SmPC) or full U.S. Prescribing Information
(including BOXED WARNING for CRS).
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,” “will,” “believe,” “expect,” “plan,” “anticipate,”
“estimate,” 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 expected clinical
benefits of KIMMTRAK, including for mUM patients with stable
disease and any confirmed tumor reduction, brenetafusp and
Immunocore’s other product candidates, including RECIST response
rate, tumor reduction, including the durability of tumor reduction,
ctDNA molecular response, progression free survival and extended
overall survival benefit; the expectation that different baseline
characteristics and responses to therapy are prognostic factors for
benefit from treatment with KIMMTRAK; the benefit of Immunocore’s
clinical data for physicians treating patients with mUM; the value
proposition of Immunocore’s products and product candidates,
including KIMMTRAK and brenetafusp; and future development plans of
Immunocore’s products and product candidates, including KIMMTRAK
and brenetafusp. Any forward-looking statements are based on
management’s current expectations and beliefs of future events and
are subject to a number of risks and uncertainties that could cause
actual events or 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,
financial position, strategy 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 health
epidemics or pandemics, war in Ukraine, the conflict between Hamas
and Israel, the broader risk of a regional conflict in the Middle
East, 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 preclinical
studies or clinical trials; actions of regulatory agencies, which
may affect the initiation, timing and progress of 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
inflation, interest rates and unfavorable general market
conditions, and the impacts thereon of the war in Ukraine, the
conflict between Hamas and Israel, and global geopolitical tension;
Immunocore’s ability to obtain, maintain and enforce intellectual
property protection for KIMMTRAK or any of its product candidates
it or its collaborators are 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 10-K for
the year ended December 31, 2023 filed with the Securities and
Exchange Commission on February 28, 2024, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information, except as required by law.
Contact Information
Immunocore
Sébastien Desprez, Head of CommunicationsT: +44
(0) 7458030732E: sebastien.desprez@immunocore.comFollow on Twitter:
@Immunocore
Investor Relations
Clayton Robertson, Head of Investor RelationsT:
+1 (215) 384-4781E: ir@immunocore.com
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