Data Supporting Summit’s Planned Phase III
Trial for First-line Metastatic Squamous NSCLC Patients on
Display
Phase II ORR of 67% with a mDOR of 15 months in
1L SQ-NSCLC Patients
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) today announced promising data for its novel, potential
first-in-class investigational bispecific antibody, ivonescimab,
that is being presented today from 8:00 to 11:00am at the 2023
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, IL.
AK112-201 (NCT04736823) is an open-label Phase II study
evaluating ivonescimab plus chemotherapy for 174 patents across
three cohorts of patients. The poster features data from 135
patients in Cohort 1 of this study: patients who are
treatment-naïve with advanced or metastatic non-small cell lung
cancer (NSCLC) whose tumors do not have actionable genomic
alterations (i.e., patients’ tumors do not have actionable
mutations in endothelial growth factor receptor (EGFR) or
anaplastic lymphoma kinase (ALK)).
Notably, this Phase II data set summarizes results to date from
63 patients with squamous histology. These patients experienced a
median progression-free survival (PFS) of 11.0 months (95% CI: 9.5
to 16.8 months) and an overall response rate (ORR) of 67% (95% CI:
53% to 78%). After a median follow-up time of 13.3 months, median
overall survival (OS) was not reached; although, estimated 9-month
OS was 93.2%. The frequency of Grade ≥3 treatment-related adverse
events (TRAEs) was 41%. The most frequent treatment-emergent
adverse events were anemia, decreased neutrophil counts, and
alopecia.
Summit has begun clinical development activities on the Phase
III HARMONi-3 study, which intends to evaluate ivonescimab combined
with chemotherapy in first-line metastatic squamous NSCLC patients.
Summit intends to treat patients in the HARMONi-3 trial during the
second half of 2023.
The poster is being presented by Dr. Li Zhang, Sun Yat-Sen
University Cancer Center,1 with data generated and analyzed by our
collaboration and licensing partner, Akeso, Inc. (HKEX Code:
9926.HK).
In addition to the patients with squamous histology described
above, Cohort 1 includes updated data from 72 patients with
non-squamous histology. Median PFS experienced by these patients
was 12.3 months (95% CI: 8.3 to 19.3 months) and median overall
survival was not reached after 13.3 months of median follow-up
time. The frequency of Grade ≥3 TRAEs was 19%. The most frequent
treatment-emergent adverse events were anemia, decreased neutrophil
counts and constipation.
The poster also contains brief updates related to the two other
cohorts in this trial:
- Cohort 2: Advanced or metastatic non-squamous EGFR-mutated
NSCLC patients whose tumor has progressed following treatment with
an EGFR-TKI
- Cohort 3: Advanced or metastatic NSCLC patients whose tumor has
progressed following PD-(L)1 therapy combined with doublet-platinum
chemotherapy.
Of the 19 patients in Cohort 2, median PFS of 8.5 months was
experienced; median overall survival was not reached. The ORR for
patients in this cohort was 68% and the median duration of response
(DOR) was 8.5 months. Approximately 32% of patients in this cohort
remained on treatment at 12 months.
There were 20 patients in Cohort 3; these patients experienced a
median PFS of 7.1 months and median OS was 15.6 months. The ORR for
patients in this cohort was 40% and the median DOR was 12.4 months.
Approximately 35% of patients in this cohort remained on treatment
at 12 months.
Ivonescimab had an acceptable safety profile in combination with
platinum-doublet chemotherapy for patients with advanced or
metastatic NSCLC who had progressed following an EGFR-TKI, as well
as in combination with chemotherapy for patients who had progressed
following treatment with a PD-(L)1 inhibitor plus platinum-doublet
chemotherapy in this clinical study.
In May 2023, the first patient was treated in Summit’s license
territories in the Phase III HARMONi clinical trial. HARMONi
intends to evaluate ivonescimab combined with chemotherapy in
patients with EGFR-mutated, locally advanced or metastatic
non-squamous NSCLC who have progressed after treatment with a
third-generation EGFR tyrosine kinase inhibitor (TKI) (AK112-301,
NCT05184712).
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 (four binding sites) 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.2 This tetravalent structure, the
intentional 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 is
intended to improve side effects and safety concerns associated
with these targets and has the potential to focus the antitumor
activity of both targets. Over 750 patients have been treated with
ivonescimab across multiple clinical studies in different
indications in China and Australia.
Lung cancer is believed to impact approximately 238,0003 people
in the United States each year and approximately 477,0004 in
Europe. NSCLC is the most prevalent type of lung cancer and
represents approximately 80% to 85% of all incidences.5 Among
patients with non-squamous NSCLC, approximately 15% have
EGFR-sensitizing mutations in the United States and Europe.6
Patients with squamous histology represent approximately 25% to 30%
of NSCLC patients.7
About the ASCO Poster
Poster Title: Phase II results of Ivonescimab (AK112/SMT112) a
novel PD-1/VEGF bispecific in combination with chemotherapy for
first line treatment of advanced or metastatic non-small cell lung
cancer (NSCLC) without actionable genomic alterations (AGA) in
EGFR/ALK
ASCO Poster Board Number: 75
ASCO Abstract No.: 9087
ASCO Poster Session: Lung Cancer – Non-Small Cell Metastatic
Poster Session.
Session Date & Time: Sunday June 4, 8:00 to 11:00am CT
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.
For more information, please visit https://www.smmttx.com and
follow us on Twitter @summitplc.
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) and
is currently engaged in multiple Phase III clinical trials in
China. Summit has begun its clinical development of ivonescimab in
NSCLC, enrolling the first patient in its license territory in
2023, with multiple Phase III clinical trials intended to be
initiated in 2023. Over 750 patients have been treated 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.
1 Poster Authors: Li Zhang, Wenfeng Fang, Yuanyuan Zhao, Yunpeng
Yang, Ningning Zhou, Likun Chen, Yan Huang, Jianhua Chen, Li
Zhuang, Yingying Du, Qitao Yu, Wu Zhuang, Yanqiu Zhao, Ming Zhou,
Weidong Zhang, Yu Zhang, Yixin Wan, Weifeng Song, Michelle Xia
2 Zhong et al, SITC 2022
3 American Cancer Society: Lung Cancer Statistics | How Common
is Lung Cancer?
4 World Health Organization: 908-europe-fact-sheets.pdf
(iarc.fr)
5 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung
Cancer. Cancer Epidemiology, Biomarkers & Prevention.
(2019).
6 About EGFR-Positive Lung Cancer | Navigating EGFR
(lungevity.org)
7 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung
Cancer. Cancer Epidemiology, Biomarkers & Prevention.
(2019).
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version on businesswire.com: https://www.businesswire.com/news/home/20230604005026/en/
Contact Summit Therapeutics: Dave Gancarz SVP,
Stakeholder Relations, Business Development, & Corporate
Strategy investors@smmttx.com
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