Phase III Study Designed to Establish the
Effect of Ivonescimab in Lung Cancer Patients Whose Tumors
Progressed after EGFR-TKI Therapy
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) today announced that the first United States-based
patient has been enrolled in the Phase III HARMONi study.
HARMONi is a Phase III multiregional, randomized, double-blinded
study. The study will evaluate the efficacy and safety of
ivonescimab combined with chemotherapy in patients with epidermal
growth factor receptor (EGFR)-mutated, locally advanced or
metastatic non-squamous non-small cell lung cancer (NSCLC) who have
progressed after treatment with a third-generation EGFR tyrosine
kinase inhibitor (TKI) such as osimertinib. Specifically, the study
will compare ivonescimab combined with pemetrexed and carboplatin
chemotherapies against a placebo plus pemetrexed and carboplatin.
The study, designed with registration intent, has two primary
endpoints: overall survival (OS) and progression-free survival
(PFS).
HARMONi, also referred to as AK112-301, will enroll patients
from the United States, Canada, Europe, and China in conjunction
with our high-achieving partner, Akeso Inc. (Akeso). Akeso is
responsible for enrollment in China, which has previously
commenced; Summit is responsible for enrollment in the United
States, Canada, and Europe. Over 400 patients are planned to be
enrolled in the study.
“Advanced or metastatic non-small cell lung cancer is such a
devastating diagnosis for patients,” said Ian Anderson, M.D.,
Medical Oncologist at Providence Medical Foundation, who treated
the first patient in HARMONi. “While we are making great strides as
a medical community to improve the quality and duration of
patients’ lives, there remains significant room for improvement in
the treatment options available for these patients. In particular,
for patients with an EGFR-mutated tumor whose tumor has progressed
after their initial TKI therapy, there are limited options. We are
particularly excited to evaluate the potential of ivonescimab in
the HARMONi study to make a meaningful impact on the lives of these
patients facing this difficult disease.”
Ivonescimab, known as SMT112 in the United States, Canada,
Europe, and Japan, and as AK112 in China and Australia, is a novel,
potential first-in-class investigational bispecific antibody
combining the effects of immunotherapy via a blockade of PD-1 with
the anti-angiogenesis effects associated with blocking VEGF into a
single molecule. There is higher expression (presence) of both PD-1
and VEGF in tumor tissue and the tumor microenvironment (TME) as
compared to normal, healthy tissue in the body. Ivonescimab’s
tetravalent structure enables higher avidity (accumulated strength
of multiple binding interactions) with over 10 fold increased
binding affinity to PD-1 in the presence of VEGF in vitro in tumor
cells.1 This tetravalent structure, the design of the molecule, and
bringing these two targets into a single bispecific antibody have
the potential to steer ivonescimab to the tumor tissue versus
healthy tissue, which are intended to improve side effects and
safety concerns associated with these targets and have the
potential to focus the antitumor activity of both targets. We look
forward to continuing to share additional details regarding
ivonescimab at upcoming medical conferences.
Over 750 patients have been treated with ivonescimab across
multiple clinical studies in China and Australia.
“Team Summit is committed to our mission to improve the quality
of lives and potential duration of lives of patients suffering from
serious unmet medical needs, starting with lung cancer,” stated Dr.
Maky Zanganeh, Co-CEO & President of Summit. “The combined work
of all involved in launching HARMONi, from the closing of deal with
Akeso to in-license ivonescimab three and a half months ago, to
ensuring alignment with the US FDA regarding study design,
preparing clinical study sites to enroll patients, readying
ivonescimab for US clinical trials, and all of the foundational
work needed to launch a clinical study, including contracts,
Institutional Review Boards’ approvals, and quality reviews, is
significant. Our commitment and dedication is clear, and we cannot
be more excited about the future of ivonescimab and its potential
to help patients who can benefit from this novel therapy.”
“I would like to sincerely thank the investigators,
coordinators, and their teams who have joined or will be a part of
our study: without your commitment, patients would not have the
opportunity to benefit from highly innovative investigational
therapies,” added Robert W. Duggan, Chairman and Co-CEO of Summit.
“Most importantly, I would like to both thank and truly appreciate
the courage of each patient around the world who will enroll in
HARMONi: your actions are the reason why each person facing a
cancer diagnosis has improved odds with each day that passes.”
Lung cancer is believed to impact approximately 238,0002 people
in the United States each year and approximately 477,0003 in
Europe. NSCLC is the most prevalent type of lung cancer and
represents approximately 80% of all incidences. Among patients with
non-squamous NSCLC, approximately 15% have EGFR-sensitizing
mutations in the United States and Europe.4
Ivonescimab is an investigational product and is not approved
for use by any health authority. Its efficacy and safety for the
treatment of any indication have not been established.
More information on the HARMONi study (NCT05184712) is available
at clinicaltrials.gov.
___________________________ 1 Zhong et al, SITC 2022 2 American
Cancer Society: Lung Cancer Statistics | How Common is Lung Cancer?
3 World Health Organization: 908-europe-fact-sheets.pdf (iarc.fr) 4
About EGFR-Positive Lung Cancer | Navigating EGFR
(lungevity.org)
Summit Therapeutics’ Mission Statement
To build a viable, long-lasting health care organization that
assumes full responsibility for designing, developing, trial
execution and enrollment, regulatory submission and approval, as
well as successful commercialization of patient, physician,
caregiver, and societal-friendly medicinal therapy intended to:
improve quality of life, increase potential duration of life, and
resolve serious medical healthcare needs. To identify and control
promising product candidates based on exceptional scientific
development and administrational expertise, develop our products in
a rapid, cost-efficient manner, and to engage commercialization
and/or development partners when appropriate.
We accomplish this by building a team of world class
professional scientists and business administrators that apply
their experience and knowledge to this mission. Team Summit exists
to pose, strategize, and execute a path forward in medicinal
therapeutic health care that places Summit in a well-deserved, top
market share, leadership position. Team Summit assumes full
responsibility for stimulating continuous expansion of knowledge,
ability, capability, and well-being for all involved stakeholders
and highly-valued shareholders.
About Summit Therapeutics
Summit was founded in 2003 and our shares are listed on the
Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Menlo
Park, California, and we have additional offices in Oxford, UK and
Cambridge, UK.
For more information, please visit https://www.smmttx.com and
follow us on Twitter @summitplc.
About HARMONi (AK112-301)
HARMONi, also known as AK112-301, is a Phase III multiregional,
randomized, double-blinded study. The intent of the study is to
compare ivonescimab combined with pemetrexed and carboplatin
chemotherapies against a placebo plus pemetrexed and carboplatin
chemotherapies. Patients will be randomized 1:1 between the two
arms of the study. The Phase III study will evaluate the efficacy
and safety of ivonescimab combined with chemotherapy in patients
with epidermal growth factor receptor (EGFR)-mutated, locally
advanced or metastatic non-squamous non-small cell lung cancer
(NSCLC) who have progressed after treatment with a third-generation
EGFR tyrosine kinase inhibitor (TKI).
There are two primary endpoints for this study: overall survival
(OS) and progression-free survival (PFS). HARMONi will enroll
patients from the United States, Canada, Europe, and China in
conjunction high-achieving partners, Akeso Inc. (Akeso). Akeso is
responsible for enrollment in China, which has previously
commenced; Summit is responsible for enrollment in the United
States, Canada, and Europe.
For more information, visit www.smmttx.com
About Ivonescimab
Ivonescimab, known as SMT112 in the United States, Canada,
Europe, and Japan (Summit’s license territories), and as AK112 in
China and Australia, is a novel, potential first-in-class
investigational bispecific antibody combining the effects of
immunotherapy via a blockade of PD-1 with the anti-angiogenesis
effects associated with blocking VEGF into a single molecule.
Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK,
“Akeso”) and is currently engaged in multiple Phase III clinical
trials in China. Summit intends to begin multiple Phase III
clinical trials in its license territories in 2023. Over 750
patients have been treating with ivonescimab in clinical studies in
China and Australia.
Summit Forward-looking Statements
Any statements in this press release about the Company’s future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company’s product candidates, entry into and actions related to the
Company’s partnership with Akeso Inc., the therapeutic potential of
the Company’s product candidates, the potential commercialization
of the Company’s product candidates, the timing of initiation,
completion and availability of data from clinical trials, the
potential submission of applications for marketing approvals, the
impact of the COVID-19 pandemic on the Company’s operations and
clinical trials, potential acquisitions and other statements
containing the words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"predict," "project," "should," "target," "would," and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including the results of our evaluation of the underlying
data in connection with the development and commercialization
activities for SMT112, the outcome of discussions with regulatory
authorities, including the Food and Drug Administration, the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials, the results of such trials, and their success, and global
public health crises, including the coronavirus COVID-19 outbreak,
that may affect timing and status of our clinical trials and
operations, whether preliminary results from a clinical trial will
be predictive of the final results of that trial or whether results
of early clinical trials or preclinical studies will be indicative
of the results of later clinical trials, whether business
development opportunities to expand the Company’s pipeline of drug
candidates, including without limitation, through potential
acquisitions of, and/or collaborations with, other entities occur,
expectations for regulatory approvals, laws and regulations
affecting government contracts and funding awards, availability of
funding sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements and other
factors discussed in the "Risk Factors" section of filings that the
Company makes with the Securities and Exchange Commission. Any
change to our ongoing trials could cause delays, affect our future
expenses, and add uncertainty to our commercialization efforts, as
well as to affect the likelihood of the successful completion of
clinical development of SMT112. Accordingly, readers should not
place undue reliance on forward-looking statements or information.
In addition, any forward-looking statements included in this press
release represent the Company’s views only as of the date of this
release and should not be relied upon as representing the Company’s
views as of any subsequent date. The Company specifically disclaims
any obligation to update any forward-looking statements included in
this press release.
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Contact Summit Therapeutics: Dave Gancarz SVP,
Stakeholder Relations, Business Development, & Corporate
Strategy investors@smmttx.com
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