Breakthrough DLL3-Targeting
Therapy Regimen for a Major Solid Tumor
IMDELLTRA Demonstrated Impressive 40%
Objective Response Rate, 9.7 Month Median Duration of Response and
14.3 Month Median Overall Survival in Pivotal DeLLphi-301
Study
Amgen to Host Webcast Investor Call on
May 20, 2024 at 1:00 p.m. PT
THOUSAND
OAKS, Calif., May 16, 2024
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S.
Food and Drug Administration (FDA) has approved IMDELLTRA™
(tarlatamab-dlle) for the treatment of adult patients with
extensive-stage small cell lung cancer (ES-SCLC) with disease
progression on or after platinum-based chemotherapy. IMDELLTRA has
received accelerated approval based on the encouraging response
rate and duration of response (DoR) observed in clinical
studies. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s).
Experience the full interactive Multichannel News Release
here:
https://www.multivu.com/players/English/9246451-fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer/
"The FDA's approval of IMDELLTRA marks a pivotal moment for
patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC
comprises a transformative option demonstrating long-lasting
responses in pretreated patients," said Jay
Bradner, M.D., executive vice president, Research and
Development, and chief scientific officer at Amgen. "This approval
further demonstrates our commitment to addressing aggressive
cancers through our second FDA-approved Bispecific T-cell Engager
(BiTE®) molecule. IMDELLTRA offers these patients who
are in urgent need of new innovative therapies hope, and we're
proud to deliver this long-awaited effective treatment to
them."
"Lung cancer is a complex and devastating disease, and less than
3% of patients with ES-SCLC live longer than five years," said
David P. Carbone, M.D., Ph.D.,
professor of internal medicine and director of the James Thoracic
Oncology Center at the Ohio State
University Medical Center.1 "In the DeLLphi-301
trial, the median overall survival was 14.3 months, with 40% of
patients responding to treatment with tarlatamab. These responses
were remarkably durable, representing a major advancement in the
SCLC treatment paradigm."
IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell
Engager therapy that activates the patient's own T cells to attack
DLL3-expressing tumor cells.2
"After decades of minimal advancements in the SCLC treatment
landscape, there is now an effective and innovative treatment
option available," said Laurie Fenton
Ambrose, co-founder, president, and CEO of GO2 for Lung
Cancer. "Today's FDA approval marks a significant milestone for the
SCLC community as the availability of a targeted bispecific therapy
brings forward new possibilities to those living with this
aggressive disease."
The FDA accelerated approval of IMDELLTRA is
based on results from the Phase 2 DeLLphi-301 clinical trial that
evaluated IMDELLTRA in patients with SCLC who had failed two or
more prior lines of treatment, and who had received the 10 mg every
two weeks dosing (Q2W) regimen. Results from the study found that
IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust
objective response rate (ORR) of 40% (95% Confidence Interval [CI]:
31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median
overall survival (mOS) was 14.3 months, with final and complete
survival data yet to mature.3
The IMDELLTRA label includes a Boxed Warning for cytokine
release syndrome (CRS) and neurologic toxicity, including immune
effector cell-associated neurotoxicity syndrome (ICANS), in
addition to warnings and precautions for cytopenias, infections,
hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The
most common (> 20%) adverse reactions reported among patients
were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%),
decreased appetite (34%), musculoskeletal pain (30%), constipation
(30%), anemia (27%), and nausea (22%). Permanent discontinuations
due to treatment-emergent adverse events (TEAEs) were infrequent
(7%). CRS was largely confined to the first and second dose,
predominantly grade 1 or 2, and was generally managed with
supportive care. Details of the Important Safety Information are
included below.
Amgen's Commitment to Patient Support
Amgen is
committed to supporting patients with ES-SCLC and to helping ensure
appropriate patients with access to IMDELLTRA. Patients,
caregivers, and physicians who need support, tools, or resources
can contact Amgen® SupportPlus. Amgen also provides
patient assistance for its medicines marketed in the U.S. in a
variety of ways, including for uninsured or under-insured patients
through the Amgen Safety Net Foundation, a nonprofit patient
assistance program sponsored by Amgen that helps qualifying
patients access Amgen medicines at no cost.
Amgen to Webcast Investor Call on IMDELLTRA FDA
Approval
Amgen will host a webcast call for the investment
community on Monday, May 20, 2024 at
1:00 p.m. PT (4:00 p.m. ET). Jay
Bradner, M.D., executive vice president, Research and
Development, and chief scientific officer at Amgen, Murdo Gordon, executive vice president of Global
Commercial Operations, and other members of the Amgen team will
participate.
Live audio of the investor call will be simultaneously broadcast
over the internet and will be available to members of the news
media, investors, and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given by management at certain
investor and medical conferences, can be found on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability, and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the event.
About IMDELLTRA™ (tarlatamab-dlle)
IIMDELLTRA is a
first-in-class immunotherapy engineered by Amgen researchers that
binds to both DLL3 on tumor cells and CD3 on T cells,
activating T cells to kill DLL3-expressing SCLC cells. This
results in the formation of a cytolytic synapse with lysis of the
cancer cell.2,4 DLL3 is a protein that is expressed on
the surface of SCLC cells in ~85-96% of patients with SCLC, but is
minimally expressed on healthy cells, making it an exciting
target.3,5
IMDELLTRA™ (tarlatamab-dlle) U.S.
Indication
IMDELLTRA™ (tarlatamab-dlle) is indicated for the
treatment of adult patients with extensive-stage small cell lung
cancer (ES-SCLC) with disease progression on or after
platinum-based chemotherapy.
This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s).
IMDELLTRA™ (tarlatamab-dlle) Important Safety
Information
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY
including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY
SYNDROME
- Cytokine release syndrome (CRS), including serious or
life-threatening reactions, can occur in patients receiving
IMDELLTRA™. Initiate treatment with IMDELLTRA™ using the
step-up dosing schedule to reduce the incidence and severity of
CRS. Withhold IMDELLTRA™ until CRS resolves or permanently
discontinue based on severity.
- Neurologic toxicity, including immune effector
cell-associated neurotoxicity syndrome (ICANS), including serious
or life-threatening reactions, can occur in patients receiving
IMDELLTRA™. Monitor patients for signs and symptoms of neurologic
toxicity, including ICANS, during treatment and treat promptly.
Withhold IMDELLTRA™ until ICANS resolves or permanently
discontinue based on severity.
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): IMDELLTRA™ can
cause CRS including serious or life-threatening reactions. In the
pooled safety population, CRS occurred in 55% of patients who
received IMDELLTRA™, including 34% Grade 1, 19% Grade 2, 1.1% Grade
3 and 0.5% Grade 4. Recurrent CRS occurred in 24% of patients,
including 18% Grade 1 and 6% Grade 2.
Most events (43%) of CRS occurred after the
first dose, with 29% of patients experiencing any grade CRS after
the second dose and 9% of patients experiencing CRS following the
third dose or later. Following the Day 1, Day 8, and Day 15
infusions, 16%, 4.3% and 2.1% of patients experienced ≥ Grade 2
CRS, respectively. The median time to onset of all grade CRS from
most recent dose of IMDELLTRA™ was 13.5 hours (range: 1 to 268
hours). The median time to onset of ≥ Grade 2 CRS from most recent
dose of IMDELLTRA™ was 14.6 hours (range: 2 to 566 hours).
Clinical signs and symptoms of CRS included
pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia,
nausea, and vomiting. Potentially life-threatening complications of
CRS may include cardiac dysfunction, acute respiratory distress
syndrome, neurologic toxicity, renal and/or hepatic failure, and
disseminated intravascular coagulation (DIC).
Administer IMDELLTRA™ following the
recommended step-up dosing and administer concomitant medications
before and after Cycle 1 IMDELLTRA™ infusions as described in
Table 3 of the Prescribing Information (PI) to reduce the risk of
CRS. Administer IMDELLTRA™ in an appropriate health care
facility equipped to monitor and manage CRS. Ensure patients are
well hydrated prior to administration of IMDELLTRA™.
Closely monitor patients for signs and symptoms
of CRS during treatment with IMDELLTRA™. At the first sign of CRS,
immediately discontinue IMDELLTRA™ infusion, evaluate the
patient for hospitalization and institute supportive care based on
severity. Withhold or permanently discontinue IMDELLTRA™ based
on severity. Counsel patients to seek medical attention should
signs or symptoms of CRS occur.
- Neurologic Toxicity, Including ICANS:
IMDELLTRA™ can cause serious or life-threatening neurologic
toxicity, including ICANS. In the pooled safety population,
neurologic toxicity, including ICANS, occurred in 47% of patients
who received IMDELLTRA™, including 10% Grade 3. The most frequent
neurologic toxicities were headache (14%), peripheral neuropathy
(7%), dizziness (7%), insomnia (6%), muscular weakness (3.7%),
delirium (2.1%), syncope (1.6%), and neurotoxicity (1.1%).
ICANS occurred in 9% of IMDELLTRA™-treated
patients. Recurrent ICANS occurred in 1.6% of patients. Most
patients experienced ICANS following Cycle 2 Day 1 (24%). Following
Day 1, Day 8, and Day 15 infusions, 0.5%, 0.5% and 3.7% of patients
experienced ≥ Grade 2 ICANS, respectively. The median time to onset
of ICANS from the first dose of IMDELLTRATM was 29.5
days (range: 1 to 154 days). ICANS can occur several weeks
following administration of IMDELLTRATM. The median time
to resolution of ICANS was 33 days (range: 1 to 93 days).
The onset of ICANS can be concurrent with CRS,
following resolution of CRS, or in the absence of CRS. Clinical
signs and symptoms of ICANS may include but are not limited to
confusional state, depressed level of consciousness,
disorientation, somnolence, lethargy, and bradyphrenia.
Patients receiving IMDELLTRA™ are at risk
of neurologic adverse reactions and ICANS resulting in depressed
level of consciousness. Advise patients to refrain from driving and
engaging in hazardous occupations or activities, such as operating
heavy or potentially dangerous machinery, in the event of any
neurologic symptoms until they resolve.
Closely monitor patients for signs and symptoms
of neurologic toxicity and ICANS during treatment. At the first
sign of ICANS, immediately evaluate the patient and provide
supportive therapy based on severity. Withhold IMDELLTRA™ or
permanently discontinue based on severity.
- Cytopenias: IMDELLTRA™ can cause cytopenias
including neutropenia, thrombocytopenia, and anemia. In the pooled
safety population, decreased neutrophils occurred in 12% including
6% Grade 3 or 4 of IMDELLTRA™-treated patients. The median time to
onset for Grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213).
Decreased platelets occurred in 33% including 3.2% Grade 3 or 4.
The median time to onset for Grade 3 or 4 decreased platelets was
50 days (range: 3 to 420). Decreased hemoglobin occurred in 58%
including 5% Grade 3 or 4. Febrile neutropenia occurred in 0.5% of
patients treated with IMDELLTRA™.
Monitor patients for signs and symptoms of
cytopenias. Perform complete blood counts prior to treatment with
IMDELLTRA™, before each dose, and as clinically indicated. Based on
the severity of cytopenias, temporarily withhold, or permanently
discontinue IMDELLTRA™.
- Infections: IMDELLTRA™ can cause serious
infections, including life-threatening and fatal infections. In the
pooled safety population, infections, including opportunistic
infections, occurred in 41% of patients who received IMDELLTRA™.
Grade 3 or 4 infections occurred in 13% of patients. The most
frequent infections were COVID-19 (9%, majority during the COVID-19
pandemic), urinary tract infection (10%), pneumonia (9%),
respiratory tract infection (3.2%), and candida infection
(3.2%).
Monitor patients for signs and symptoms of
infection prior to and during treatment
with IMDELLTRA™ and treat as clinically indicated.
Withhold or permanently discontinue IMDELLTRA™ based on
severity.
- Hepatotoxicity: IMDELLTRA™ can cause
hepatotoxicity. In the pooled safety population, elevated ALT
occurred in 42%, with Grade 3 or 4 ALT elevation occurring in 2.1%.
Elevated AST occurred in 44% of patients, with Grade 3 or 4 AST
elevation occurring in 3.2%. Elevated bilirubin occurred in 15% of
patients; Grade 3 or 4 total bilirubin elevations occurred in 1.6%
of patients. Liver enzyme elevation can occur with or without
concurrent CRS. Monitor liver enzymes and bilirubin prior to
treatment with IMDELLTRA™, before each dose, and as clinically
indicated. Withhold IMDELLTRA™ or permanently discontinue
based on severity.
- Hypersensitivity: IMDELLTRA™ can cause severe
hypersensitivity reactions. Clinical signs and symptoms of
hypersensitivity may include, but are not limited to, rash and
bronchospasm. Monitor patients for signs and symptoms of
hypersensitivity during treatment with IMDELLTRA™ and manage
as clinically indicated. Withhold or consider permanent
discontinuation of IMDELLTRA™ based on severity.
- Embryo-Fetal Toxicity: Based on its mechanism of
action, IMDELLTRA™ may cause fetal harm when administered to a
pregnant woman. Advise patients of the potential risk to a fetus.
Advise females of reproductive potential to use effective
contraception during treatment with IMDELLTRA™ and for 2
months after the last dose.
ADVERSE REACTIONS
- The most common (> 20%) adverse reactions were CRS (55%),
fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite
(34%), musculoskeletal pain (30%), constipation (30%), anemia (27%)
and nausea (22%). The most common (≥ 2%) Grade 3 or 4 laboratory
abnormalities were decreased lymphocytes (57%), decreased sodium
(16%), increased uric acid (10%), decreased total neutrophils (6%),
decreased hemoglobin (5%), increased activated partial
thromboplastin time (5%), decreased potassium (5%), increased
aspartate aminotransferase (3.2%), decreased white blood cells
(3.8%), decreased platelets (3.2%), and increased alanine
aminotransferase (2.1%).
- Serious adverse reactions occurred in 58% of patients. Serious
adverse reactions in > 3% of patients included CRS (24%),
pneumonia (6%), pyrexia (3.7%), and hyponatremia (3.6%). Fatal
adverse reactions occurred in 2.7% of patients including pneumonia
(0.5%), aspiration (0.5%), pulmonary embolism (0.5%), respiratory
acidosis (0.5%), and respiratory failure (0.5%).
DOSAGE AND ADMINISTRATION: Important Dosing
Information
- Administer IMDELLTRA™ as an intravenous infusion over one
hour.
- Administer IMDELLTRA™ according to the step-up dosing
schedule in the IMDELLTRA™ PI (Table 1) to reduce the
incidence and severity of CRS.
- For Cycle 1, administer recommended concomitant medications
before and after Cycle 1 IMDELLTRA™ infusions to reduce the
risk of CRS reactions as described in the PI (Table 3).
- IMDELLTRA™should only be administered by a qualified healthcare
professional with appropriate medical support to manage severe
reactions such as CRS and neurologic toxicity including ICANS.
- Due to the risk of CRS and neurologic toxicity, including
ICANS, monitor patients from the start of the
IMDELLTRA™ infusion for 22 to 24 hours on Cycle 1 Day 1 and
Cycle 1 Day 8 in an appropriate healthcare setting.
- Recommend that patients remain within 1 hour of an appropriate
healthcare setting for a total of 48 hours from start of the
infusion with IMDELLTRA™ following Cycle 1 Day 1 and Cycle 1
Day 8 doses, accompanied by a caregiver.
- Prior to administration of IMDELLTRA™ evaluate complete
blood count, liver enzymes, and bilirubin before each dose, and as
clinically indicated.
- Ensure patients are well hydrated prior to administration of
IMDELLTRA™.
Please see
IMDELLTRA™ full Prescribing Information, including
BOXED WARNINGS.
About Small Cell Lung Cancer (SCLC)
SCLC is one of the
most aggressive and devastating solid tumor malignancies, with a
median survival of approximately 12 months following initial
therapy and a 3% five-year relative survival rate for
ES-SCLC.1,6,7 Current second-line treatments impart
a short duration of response (median DoR: 3.3–5.3 months) and
limited survival (median OS: 5.8-9.3 months), while current
third-line treatments for SCLC, which consist primarily of
chemotherapy, yield a short median DoR of 2.6 months and a
median OS of 4.4-5.3 months.8-12 SCLC comprises ~15% of
the 2.4 million plus patients diagnosed with lung cancer worldwide
each year.13-15 Despite initial high response rates to
first-line platinum-based chemotherapy, most patients quickly
relapse within months and require subsequent treatment
options.13
About Tarlatamab Clinical Trials
Amgen's robust
tarlatamab development program includes the DeLLphi clinical
trials, which evaluate tarlatamab as both a monotherapy and in
combination regimens in earlier lines of SCLC, and DeLLpro clinical
trials, which evaluate the efficacy and safety of 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.16 In the Phase 2
DeLLphi-301 study, tarlatamab administered as 10 mg dose every two
weeks demonstrated an ORR of 40% in patients with advanced SCLC who
had failed two or more prior lines of treatment. In the
DeLLphi-301 Phase 2 trial, the most frequent treatment-related
adverse events seen with 10 mg Q2W dosing regimen were CRS (51%),
pyrexia (32%), and decreased appetite (23%). CRS events were
predominantly grade 1 or 2 and occurred most often after the first
or second dose.2 Treatment discontinuation for adverse
events occurred in 4-7% of patients in the two
trials.3,16
Tarlatamab is being investigated in multiple studies including
DeLLphi-303, a Phase 1b study
investigating tarlatamab in combination with standard of care
therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3
trial comparing tarlatamab monotherapy with standard of care
chemotherapy in second-line treatment of SCLC; DeLLphi-305, a
randomized Phase 3 trial comparing tarlatamab in combination with
durvalumab versus durvalumab alone as first-line maintenance
treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled
Phase 3 trial of tarlatamab following concurrent chemoradiotherapy
in limited-stage SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or
treatment-emergent neuroendocrine prostate cancer.17
For more information, please visit
www.tarlatamabclinicaltrials.com.
About Bispecific T-Cell Engager (BiTE®)
Technology
BiTE technology is a targeted immuno-oncology
platform that is designed to engage a 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 cancer 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. For more than a decade, Amgen has been advancing
this innovative technology, which has demonstrated strong efficacy
in hematological malignancies and now a solid tumor with the
approval of IMDELLTRA. Amgen remains committed to progressing
multiple BiTE molecules across a broad range of hematologic and
solid tumor malignancies, paving the way for additional
applications in more tumor types. Amgen is further investigating
BiTE technology with the goal of enhancing patient experience and
therapeutic potential. To learn more about BiTE
technology, visit BiTE® Technology 101.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
medicines to help millions of patients in their fight against some
of the world's toughest diseases. More than 40 years ago, Amgen
helped to establish the biotechnology industry and remains on the
cutting-edge of innovation, using technology and human genetic data
to push beyond what's known today. Amgen is advancing a broad and
deep pipeline that builds on its existing portfolio of medicines to
treat cancer, heart disease, osteoporosis, inflammatory diseases
and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative
Companies" by Fast Company and one of "America's Best Large
Employers" by Forbes, among other external
recognitions Amgen is one of the 30 companies that comprise
the Dow Jones Industrial Average®, and it is also part
of the Nasdaq-100 Index®, which includes the largest and
most innovative non-financial companies listed on the Nasdaq Stock
Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X,
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(apremilast) (including anticipated Otezla sales growth and the
timing of non-GAAP EPS accretion), our acquisitions of Teneobio,
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CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407
(media)
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References
- American Cancer Society. Lung Cancer Survival Rates.
www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed on March 15, 2024.
- Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a Half-Life
Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High
Potency and Sensitivity in Preclinical Models of Small-Cell Lung
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SOURCE Amgen