Publication Entitled: Ivonescimab Plus
Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant: A
Randomized Clinical Trial
HARMONi-A was Featured in Oral Presentation at
ASCO 2024 on May 31, 2024
Conference Call to be Held at 8:00am ET on
Monday, June 3, 2024
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) announced that the Journal of the American Medical
Association (JAMA) published a manuscript titled, “Ivonescimab Plus
Chemotherapy in Non-Small Cell Lung Cancer with EGFR Variant: A
Randomized Clinical Trial.” The publication is based on the results
of HARMONi-A, a single region, multi-center, Phase III study
conducted in China sponsored by Akeso, Inc. (Akeso, HKEX Code:
9926.HK), with data generated and analyzed by Akeso.
HARMONi-A evaluated ivonescimab combined with platinum-doublet
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 an EGFR tyrosine kinase inhibitor (TKI) against
placebo plus platinum-doublet chemotherapy. This is a clinical
setting with a patient population where PD-1 monoclonal antibodies
have previously been unsuccessful in Phase III global clinical
trials. The Phase III HARMONi-A study provides further evidence
supporting the differentiated mechanism of action of ivonescimab, a
PD-1 / VEGF bispecific antibody evidencing cooperative binding
characteristics.
Conference Call
Summit Therapeutics Inc. will host a conference call to discuss
recent updates related to ivonescimab, including data released at
ASCO, on Monday, June 3, 2024, before the market opens.
Summit will host a live webcast of the conference call at 8:00am
ET, which will be accessible through our website www.smmttx.com,
and can also be accessed via the following link:
https://events.q4inc.com/attendee/130822402.
The dial-in information for US attendees is toll-free at (800)
715-9871. Additionally, all attendees may access through the toll
number, (646) 307-1963. The Conference ID is 4259251.
An archived edition of the webcast will be available on our
website later in the day on Monday.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
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. Ivonescimab displays unique
cooperative binding to each of its intended targets with higher
affinity when in the presence of both PD-1 and VEGF.
This could differentiate ivonescimab as there is potentially
higher expression (presence) of both PD-1 and VEGF in tumor tissue
and the tumor microenvironment (TME) as compared to normal tissue
in the body. Ivonescimab’s tetravalent structure (four binding
sites) enables higher avidity (accumulated strength of multiple
binding interactions) in the tumor microenvironment with over
18-fold increased binding affinity to PD-1 in the presence of VEGF
in vitro, and over 4-times increased binding affinity to VEGF in
the presence of PD-1 in vitro.1 This tetravalent structure, the
intentional novel design of the molecule, and bringing these two
targets into a single bispecific antibody with cooperative binding
qualities have the potential to direct ivonescimab to the tumor
tissue versus healthy tissue. The intent of this design, together
with a half-life of 6 to 7 days,1 is to improve upon previously
established efficacy thresholds, in addition to side effects and
safety profiles associated with these targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK)
and is currently engaged in multiple Phase III clinical trials.
Over 1,600 patients have been treated with ivonescimab in clinical
studies globally. Summit has begun its clinical development of
ivonescimab in non-small cell lung cancer (NSCLC), commencing
enrollment in 2023 in two Phase III clinical trials, HARMONi and
HARMONi-3.
HARMONi is a Phase III clinical trial which intends to evaluate
ivonescimab combined with chemotherapy compared to placebo plus
chemotherapy in patients with EGFR-mutated, locally advanced or
metastatic non-squamous NSCLC who have progressed after treatment
with a 3rd generation EGFR TKI (e.g., osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to
evaluate ivonescimab combined with chemotherapy compared to
pembrolizumab combined with chemotherapy in patients with
first-line metastatic squamous NSCLC.
Ivonescimab is an investigational therapy that is not approved
by any regulatory authority in Summit’s license territories,
including the United States and Europe. Ivonescimab was approved
for marketing authorization in China in May 2024.
About Lung Cancer
Lung cancer is believed to impact approximately 600,000 people
across the United States, United Kingdom, Spain, France, Italy,
Germany, and Japan.2 NSCLC is the most prevalent type of lung
cancer and represents approximately 80% to 85% of all incidences.3
Among patients with non-squamous NSCLC, approximately 15% have
EGFR-sensitizing mutations in the United States and Europe.4
Patients with squamous histology represent approximately 25% to 30%
of NSCLC patients.5
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company
focused on the discovery, development, and commercialization of
patient-, physician-, caregiver- and societal-friendly medicinal
therapies intended to improve quality of life, increase potential
duration of life, and resolve serious unmet medical needs.
Summit was founded in 2003 and our shares are listed on the
Nasdaq Global Market (symbol "SMMT"). We are headquartered in
Miami, Florida, and we have additional offices in Menlo Park,
California, and Oxford, UK.
For more information, please visit https://www.smmttx.com and
follow us on X @summitplc.
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 Company's anticipated
spending and cash runway, 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,
potential acquisitions, statements about the previously disclosed
At-The-Market equity offering program (“ATM Program”), the expected
use proceeds and uses thereof, 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
Company’s ability to sell shares of our common stock under the ATM
Program, the conditions affecting the capital markets, general
economic, industry, or political conditions, including the results
of our evaluation of the underlying data in connection with the
development and commercialization activities for ivonescimab, 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, 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 ivonescimab. 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.
________________________________ 1 Zhong, et al, SITC 2023 2
American Cancer Society:
www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html.
Accessed April 2024; World Health Organization: International
Agency for Research on Cancer, Globocan data by country (UK, Spain,
France, Italy, Germany); Japan National Cancer Registry. 3 Schabath
MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer
Epidemiology, Biomarkers & Prevention. (2019). 4 About
EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org). 5
Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer.
Cancer Epidemiology, Biomarkers & Prevention. (2019).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240601936827/en/
Contact Summit Investor Relations: Dave Gancarz Chief
Business & Strategy Officer
Nathan LiaBraaten Senior Director, Investor Relations
investors@smmttx.com
Grafico Azioni Summit Therapeutics (NASDAQ:SMMT)
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