Currently There are no Approved Therapeutic
Options for Third-Line Treatment of Advanced
SCLC1
If Approved, Tarlatamab Would be the First
BiTE® Therapy for a Major Solid Tumor
FDA Target Action Date is June 12, 2024
THOUSAND
OAKS, Calif., Dec. 13,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted and granted Priority Review for the Company's Biologics
License Application (BLA) for tarlatamab.
Tarlatamab is a potential first-in-class, investigational
delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager
(BiTE®) therapy for the treatment of adult patients with
advanced small cell lung cancer (SCLC) with disease progression on
or after platinum-based chemotherapy.
"The FDA's Priority Review designation for this application
underscores the urgency to provide new treatment options for
patients with advanced SCLC who have progressed following treatment
with platinum-based chemotherapy," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "While first-line treatments
often show strong responses, patients can experience aggressive
recurrences and long-term survival remains a
challenge.2,3 Unfortunately, for patients who relapse,
there are limited treatment options, emphasizing the importance of
bringing new therapies to this patient population with advanced
disease."
The FDA grants Priority Review to applications for medicines
that offer, if approved, significant improvements over available
options or may provide a treatment option where no adequate therapy
currently exists. Based on the Priority Review designation, the
Prescription Drug User Fee Action (PDUFA) date for tarlatamab is
June 12, 2024.
The BLA is based on the Phase 2 results from the DeLLphi-301
clinical trial that studied patients with advanced SCLC with
disease progression on or after platinum-based chemotherapy.
Results from the study were recently featured as part of a
late-breaking presentation during the 2023 European Society for
Medical Oncology (ESMO) Congress and simultaneously published in
the New England Journal of Medicine.4,5 The
data presented demonstrated antitumor activity with a durable
response and encouraging survival outcomes in previously treated
SCLC. The safety profile was consistent with the Phase 1
trial.6
Tarlatamab is being investigated in multiple studies including
DeLLphi-302, a Phase 1b 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; DeLLphi-304, a
randomized Phase 3 trial comparing tarlatamab monotherapy with
standard of care chemotherapy in second-line treatment of SCLC that
is enrolling patients; DeLLphi-306, a recently-initiated,
randomized Phase 3 trial of tarlatamab following chemoradiotherapy
in earlier settings of SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or
treatment-emergent neuroendocrine prostate cancer.7
Amgen also plans to initiate an additional Phase 3 study of
tarlatamab in first-line treatment of SCLC.
In October, tarlatamab was granted Breakthrough Therapy
Designation by the FDA. The application is being reviewed by the
FDA under the Project Orbis framework and Real Time Oncology Review
(RTOR). Project Orbis is an initiative from the FDA Oncology Center
of Excellence that provides a framework for concurrent submission
of oncology products among certain countries.
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 when all stages are
combined.8-10 Of the more than 2.2 million patients
diagnosed with lung cancer worldwide each year, SCLC comprises 15%
of cases.11,1 Despite initial high response rates to
platinum-based first-line chemotherapy, patients quickly relapse
and require subsequent treatment options.1
About Tarlatamab
Tarlatamab is an investigational,
targeted therapy 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 a cytolytic synapse with lysis of the cancer
cell.12,13 DLL3 represents an exciting therapeutic
target for patients with SCLC, as approximately 85% to 96% of
patients have expression of DLL3 on the cell surface of SCLC cells,
with minimal expression in normal cells.6,14-16
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, and DeLLpro
clinical trials, which evaluate tarlatamab in neuroendocrine
prostate cancer.
In the Phase 1 DeLLphi-300 study, tarlatamab showed responses in
23.4% of patients with encouraging durability in heavily
pre-treated patients with SCLC. In the Phase 2 DeLLphi-301 study,
tarlatamab administered as 10 mg dose every two weeks demonstrated
an objective response rate of 40% in patients with advanced SCLC
who had failed two or more prior lines of treatment. In both
DeLLphi-300 and DeLLphi-301, the most frequent treatment-related
adverse events were cytokine release syndrome (CRS; 52-55%),
pyrexia (31-37%), and dysgeusia (22-26%), which were primarily
grade 1-2. Treatment discontinuation for adverse events occurred in
3-4% of patients in the two trials.5,6
For more information, please visit
www.tarlatamabclinicaltrials.com.
About BiTE® Technology
Bispecific
T-cell Engager (BiTE®) 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 multiple 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
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(apremilast) (including anticipated Otezla sales growth and the
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the ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc
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CONTACT: Amgen, Thousand
Oaks
Elissa Snook, 609-251-1407
(media)
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
References
- Oronsky B, et al. J Cancer. 2022;13:2945-2953.
- Sabari JK, et al. Nat Rev Clin
Oncol. 2017;14:549-561.
- Petty WJ, et al. Jama Oncol.
2023;9(3):419-429.
- Paz-Ares L, et al. Presented at ESMO 2023 Congress.
Oct. 20-24, 2023; Madrid, Spain. Abstract #LBA92.
- Ahn MJ, et al. N Engl J Med.
2023;389:2063-2075.
- Paz-Ares L, et al. J Clin Oncol.
2023;41:2893-2903.
- ClinicalTrials.gov tarlatamab clinical trial listings.
Available at www.clinicaltrials.gov. Accessed Dec. 4, 2023.
- 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 November 7, 2023.
- Paz-Ares L, et al. ESMO Open. 2022;7:100408.
- Liu SV, et al. J Clin Oncol. 2021;39:619-630
- World Health Organization. Lung Cancer Factsheet. 2020.
Available
at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed on November 7, 2023.
- Baeuerle PA, et al. Curr Opin Mol Ther.
2009;11:22-30.
- Giffin MJ, et al. Clin Cancer
Res. 2021;27:1526-1537.
- Rojo F, et al. Lung Cancer. 2020;147:237-243.
- Saunders LR, et al. Sci Transl Med. 2015;7:302ra136.
- Ahn MJ, et al. N Engl J Med.
2023;349:2063-2075.
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