Tarlatamab Delivered an Encouraging Objective
Response Rate of 40% and Median Overall Survival of 14.3 Months in
Patients with Advanced SCLC
Late-Breaking Data Presented at ESMO and
Published in the New England Journal of Medicine (NEJM)
Tarlatamab is an Investigational Delta-Like
Ligand 3 (DLL3) Targeting BiTE® Molecule
THOUSAND
OAKS, Calif., Oct. 20,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced results from the global Phase 2 DeLLphi-301 study,
evaluating tarlatamab, an investigational delta-like ligand 3
(DLL3) targeting BiTE® (bispecific T-cell engager)
molecule, in patients with advanced stage small cell lung cancer
(SCLC) who had failed two or more prior lines of treatment. The
data are being presented today at 3:20 PM
CEST at a Proffered Paper session as a late-breaking oral
presentation (LBA92) during the European Society for Medical
Oncology (ESMO) Congress 2023 in Madrid,
Spain, with publication in the New England Journal
of Medicine.
With a median follow-up of 10.6 months, an intention-to-treat
analysis that included 100 patients at the selected 10 mg dose for
tarlatamab demonstrated an objective response rate (ORR; primary
endpoint) of 40% (97.5% Confidence Interval (CI): 29, 52). For key
secondary endpoints, median progression-free survival (mPFS) was
4.9 months (95% CI: 2.9, 6.7) and median overall survival (mOS) was
14.3 months (95% CI: 10.8, NE). Median response duration was not
reached. Of the patients who responded to treatment with tarlatamab
at 10 mg dose, 58% experienced at least six months of response and
55% of responses were ongoing at data cutoff.
"Small cell lung cancer has represented one of the greatest
challenges in cancer treatment, where there has been little
progress against this deadly tumor type in decades," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "The tarlatamab
results show the potential for this BiTE® molecule
in a common solid tumor. We look forward to discussing these
potentially registrational data with regulatory authorities."
There were no new safety signals observed compared to Phase 1
study. Discontinuations due to treatment-related adverse events
(TRAEs) were infrequent (4%). The most common treatment-emergent
adverse events (TEAEs) reported among patients in the tarlatamab 10
mg group, were cytokine release syndrome (CRS; 49%), pyrexia (38%),
decreased appetite (25%) and dysgeusia (24%). CRS was largely
confined to the first and second dose, predominantly grade 1 or 2
and were generally managed with supportive care. At the tarlatamab
10 mg dose, grade 3 CRS was low (0%) and grade 3 immune effector
cell-associated neurotoxicity syndrome (ICANS) and associated
neurologic events were not observed (0%). There were no reported
grade 4 or 5 cases for either of these two adverse events.
"In the current third-line treatment of SCLC, patients face a
dire prognosis, with response rates ranging between 14 and 21
percent and median overall survival less than six months," said
Luis Paz-Ares, M.D., Ph.D.,
chairman, Medical Oncology Department, Hospital Doce de Octubre;
Head, Lung Cancer Unit, National Oncology Research Center (CNIO);
associate professor, Universidad Complutense.
About Tarlatamab
Tarlatamab is an investigational, targeted immunotherapy engineered
by Amgen researchers that brings a patient's own T cells in
close proximity to SCLC cells by binding both CD3 on T cells and
DLL3 on SCLC cells. This results in the formation of an
immunological synapse with lysis of the cancer
cell.1,2 DLL3 represents an
exciting therapeutic target for patients with SCLC, as
approximately 85% to 94% of patients have expression of DLL3 on the
cell surface of SCLC cells, with minimal expression in normal
cells.3,4,5
In a Phase 1 study, tarlatamab showed responses in 23.0% of
patients with encouraging durability in heavily pre-treated
patients with SCLC.
Amgen is currently investigating tarlatamab in multiple
trials, including DeLLphi-304, a Phase 3 study comparing tarlatamab
versus standard of care chemotherapy in second-line treatment of
SCLC that is enrolling patients. Amgen has plans to initiate two
additional Phase 3 studies of tarlatamab in earlier settings of
SCLC.
About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating solid tumors
with a median survival of approximately 12 months following initial
therapy and a 7% five-year relative survival rate across all stages
6,7,8 Of the 2.2M+ patients diagnosed with lung cancer
worldwide each year, SCLC comprises 15% of
cases.9,10
Despite initial high response rates to platinum-based first-line
chemotherapy, patients quickly develop resistance to second-line
and subsequent therapies and face a median time of survival of 10
to 12 months after diagnosis.11 Furthermore, there are
currently no approved therapeutic options in the third-line
treatment of SCLC.
About Tarlatamab Clinical Trials
Amgen's robust
tarlatamab development program includes the DeLLphi clinical
trials, which evaluate tarlatamab as a monotherapy and as part of
combination regimens in earlier stages of SCLC.
Tarlatamab is being investigated in multiple studies, including
DeLLphi-301, a potentially registrational Phase 2 study to evaluate
the efficacy, safety, tolerability, and pharmacokinetics of
tarlatamab in third-line or later relapsed/refractory SCLC.
Additional clinical studies underway include DeLLphi-302, a
Phase 1b combination study evaluating
tarlatamab in combination with an anti-PD-1 therapy in second-line
or later SCLC; DeLLphi-303, a Phase 1b study investigating tarlatamab in combination
with standard of care therapies in first-line SCLC; and
DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab
monotherapy with standard of care therapy in patients with SCLC who
have relapsed following first-line platinum-based
chemotherapy.12 Amgen also plans to initiate two
additional Phase 3 studies of tarlatamab in earlier settings of
SCLC.
For more information, please
visit www.tarlatamabclinicaltrials.com.
About BiTE®
Technology
BiTE® (bispecific T-cell engager)
technology is a targeted immuno-oncology platform that is designed
to engage patient's own T cells to any tumor-specific antigen,
activating the cytotoxic potential of T cells to eliminate
detectable cancer. The BiTE immuno-oncology platform has the
potential to treat different tumor types through tumor-specific
antigens. The BiTE platform has a goal of leading to off-the-shelf
solutions, which have the potential to make innovative T cell
treatment available to all providers when their patients need
it. Amgen is advancing more than a dozen BiTE molecules
across a broad range of hematologic malignancies and solid tumors,
further investigating BiTE technology with the goal of enhancing
patient experience and therapeutic potential. To learn more about
BiTE technology, visit
https://www.amgenoncology.com/bite-platform.html.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2023, Amgen was named one of "America's Greatest Workplaces" by
Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best
Companies" by TIME.
For more information, visit Amgen.com and follow us on
X (formerly known as Twitter), LinkedIn, Instagram, TikTok,
YouTube and Threads.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd. or
Kyowa-Kirin Co., Ltd.), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), the Teneobio, Inc. acquisition, the
ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc
acquisition (including the prospective performance and outlook of
Horizon's business, performance and opportunities and any potential
strategic benefits, synergies or opportunities expected as a result
of such acquisition), as well as estimates of revenues, operating
margins, capital expenditures, cash, other financial metrics,
expected legal, arbitration, political, regulatory or clinical
results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes, effects of
pandemics or other widespread health problems on our business,
outcomes, progress, and other such estimates and results.
Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products, including our devices, after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
subject to significant sanctions. Further, while we routinely
obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged,
invalidated or circumvented by our competitors, or we may fail to
prevail in present and future intellectual property litigation. We
perform a substantial amount of our commercial manufacturing
activities at a few key facilities, including in Puerto Rico, and also depend on third parties
for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
candidate development. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. The
discovery of significant problems with a product similar to one of
our products that implicate an entire class of products could have
a material adverse effect on sales of the affected products and on
our business and results of operations. Our efforts to collaborate
with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. There can be no
guarantee that we will be able to realize any of the strategic
benefits, synergies or opportunities arising from the Horizon
acquisition, and such benefits, synergies or opportunities may take
longer to realize than expected. We may not be able to
successfully integrate Horizon, and such acquisition or integration
may take longer, be more difficult or cost more than expected. A
breakdown, cyberattack or information security breach of our
information technology systems could compromise the
confidentiality, integrity and availability of our systems and our
data. Our stock price is volatile and may be affected by a number
of events. Our business and operations may be negatively affected
by the failure, or perceived failure, of achieving our
environmental, social and governance objectives. The effects of
global climate change and related natural disasters could
negatively affect our business and operations. Global economic
conditions may magnify certain risks that affect our business. Our
business performance could affect or limit the ability of our Board
of Directors to declare a dividend or our ability to pay a dividend
or repurchase our common stock. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates. Further, any
scientific information discussed in this news release relating to
new indications for our products is preliminary and investigative
and is not part of the labeling approved by the U.S. Food and Drug
Administration for the products. The products are not approved for
the investigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses.
CONTACT: Amgen, Thousand
Oaks
Elissa Snook, 609-251-1407
(media)
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
1 Paz-Ares
L, et al. J Clin Oncol. 2023.
DOI:10.1200/JCO.22.02823.
|
2 Giffin MJ,
et al. Clin Cancer Res. 2021;27:1526-1537.
|
3 Rojo F, et
al. Lung Cancer. 2020;147:237-243.
|
4 Saunders
LR, et al. Sci Transl Med. 2015;7:302ra136.
|
5 Paz-Ares
L, et al. J Clin Oncol. 2023;41:2893-2903.
|
6 American
Cancer Society. Lung Cancer Survival Rates. 2023. Available at:
https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed on October 11, 2023.
|
7 Paz-Ares
L, et al. ESMO Open. 2022;7:100408.
|
8 Liu SV, et
al. J Clin Oncol. 2021;39:619-630.
|
9 World
Health Organization. Lung. 2020. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed on October 11, 2023.
|
10 Oronsky B, et al. J Cancer.
2022;13:2945-2953.
|
11 Rudin CM,
et al. J Clin Oncol. 2015; 33:4106-4111.
|
12
ClinicalTrials.gov. DeLLphi-304. 2023. Available
at: https://classic.clinicaltrials.gov/ct2/show/NCT05740566.
Accessed on October 11, 2023.
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/amgen-presents-new-tarlatamab-data-in-small-cell-lung-cancer-301963139.html
SOURCE Amgen