Immunocore converts Phase 2/3 TEBE-AM clinical
trial into registrational Phase 3 trial evaluating KIMMTRAK for
previously treated advanced cutaneous melanoma
Following recent consultation with FDA,
all patients randomized from start of TEBE-AM Phase 2/3 trial will
be included in the Phase 3 intent-to-treat population
Phase 3 will continue three arms:
KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab,
and control
Expected to accelerate time to final
Phase 3 overall survival analysis
(OXFORDSHIRE, England & CONSHOHOCKEN, PA
& ROCKVILLE, MD, US, 29 May 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 announced that the TEBE-AM Phase 2/3 clinical trial has been
converted into a Phase 3 trial.
The Phase 2/3 TEBE-AM trial was designed to
evaluate KIMMTRAK® (tebentafusp-tebn), as monotherapy and in
combination with pembrolizumab, versus a control arm, for the
treatment of patients with previously treated advanced cutaneous
melanoma. The trial was originally designed as an adaptive Phase
2/3 trial with the optionality to review Phase 2 data and drop an
arm. Following consultation with the FDA, the Company has decided
to conduct the trial solely as a Phase 3 with the primary endpoint
of overall survival. As a result of the recent rapid accrual, the
Company projects that the Phase 3 trial would be mostly enrolled by
the time the Phase 2 overall survival would have matured. In
addition, the three arm Phase 3 will allow more robust testing of
KIMMTRAK as monotherapy and in combination versus a control arm.
Finally, with all patients randomized to date to be included in the
intent-to-treat population, the time to final analysis of the Phase
3 trial will be accelerated.
Mark Moyer, SVP, Regulatory Affairs,
Immunocore said: “The decision to launch a registrational
trial in cutaneous melanoma was based on KIMMTRAK’s overall
survival benefit in uveal melanoma, and promising clinical activity
as monotherapy and in combination with immune checkpoint therapy in
Phase 1 cutaneous melanoma trials. To allow robust testing of two
KIMMTRAK regimens and to accelerate the time to primary analysis,
we decided, in consultation with the FDA, to amend the protocol
into a single Phase 3 registrational study.”
The registrational TEBE-AM trial was initiated
following results from a Phase 1b trial of tebentafusp in
combination with checkpoint inhibitors in metastatic cutaneous
melanoma (mCM). The Phase 1b data showed that the maximum target
doses of tebentafusp (68 mcg) plus durvalumab (20 mg/kg) were well
tolerated, and that, in mCM patients who progressed on prior
anti-PD(L)1, the combination demonstrated a one-year overall
survival rate of ~75%.
About ImmTAC®
molecules for cancer
Immunocore’s proprietary T cell receptor (TCR)
technology generates a novel class of bispecific biologics called
ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules
that are designed to redirect the immune system to recognize and
kill cancerous cells. ImmTAC molecules are soluble TCRs engineered
to recognize 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 tumors, the ImmTAC
mechanism of action holds the potential to treat hematologic and
solid tumors, regardless of mutational burden or immune
infiltration, including immune “cold” low mutation rate tumors.
About TEBE-AM - Phase 3 registrational
trial with tebentafusp in previously treated advanced cutaneous
melanoma
The Phase 3 TEBE-AM trial is randomizing
patients with second-line or later cutaneous melanoma who have
progressed on an anti-PD1, received prior ipilimumab and, if
applicable, received a BRAF kinase inhibitor. Patients are
randomized to one of three arms, including tebentafusp, as
monotherapy or in combination with an anti-PD1, and a control arm.
The primary endpoint is overall survival.
About Cutaneous Melanoma
Cutaneous melanoma (CM) is the most common form
of melanoma. It is the most aggressive skin carcinoma and is
associated with the vast majority of skin cancer-related
mortality. The majority of patients with CM are diagnosed
before metastasis and survival remains poor for the large
proportion of patients with metastatic disease. Despite recent
progress in advanced melanoma therapy, there is still an unmet need
for new therapies that improve first-line response rates
and duration of response as well as for patients who are
refractory to first-line treatments.
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of
melanoma, which affects the eye. Although it is the most common
primary intraocular malignancy in adults, the diagnosis is rare,
and up to 50% of people with uveal melanoma will eventually develop
metastatic disease. Unresectable or metastatic uveal melanoma
typically has a poor prognosis and had no approved treatment until
KIMMTRAK.
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.
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).
About KIMMTRAKConnect
Immunocore is committed to helping patients who
need KIMMTRAK obtain access via our KIMMTRAKConnect program. The
program provides services with dedicated nurse case managers who
provide personalized support, including educational resources,
financial assistance, and site of care coordination. To learn more,
visit KIMMTRAKConnect.com or call 844-775-2273.
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.
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; the potential of KIMMTRAK for patients with
uveal and cutaneous melanoma; and the Company’s expectations
regarding the design, progress, timing, randomization and scope of
the Phase 3 trial evaluating KIMMTRAK for previously treated
advanced cutaneous melanoma. 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 the Company’s
control. These risks and uncertainties include, but are not limited
to, the impact of worsening macroeconomic conditions on the
Company’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
Communications
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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