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INDICATIONS

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. …READ MORE

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).

 * Now Approved
 * Important Safety Information
 * Indication
 * For Patients & Caregivers
 * Prescribing Information
 * Medication Guide
 * Request a rep

 * About IMDELLTRA™
 * Clinical Results
   * DeLLphi-301
   * Efficacy
 * Safety
 * Starting IMDELLTRA™
 * Resources
   & Support
   * Amgen® SupportPlus
   * Resources & links
 * Important Safety Information
 * Indication
 * Request a rep






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TAKE PATIENTS FORWARD WITH IMDELLTRA™

THE FIRST AND ONLY FDA-APPROVED DLL3-TARGETING BISPECIFIC T-CELL ENGAGER (BITE®)
THERAPY FOR 2L+ ES-SCLC WITH BREAKTHROUGH, DURABLE EFFICACY1

CLINICAL TRIAL
RESULTS

Efficacy

STARTING
IMDELLTRA™

Dosing & Administration

IMDELLTRA™
SUMMARY

Product Highlights

DeLLphi-301 was a phase 2, open-label, multicenter, multi-cohort clinical trial
evaluating IMDELLTRA™ 10 mg in 99 patients with 3L+ ES-SCLC, disease progression
after previous treatment with platinum‐based chemotherapy and at least one other
line of prior therapy, ECOG PS 0–1, and ≥ 1 measurable lesion (RECIST v1.1).
Overall response rate (ORR) was 40% (n=40/99; 95% CI: 31–51; CR: 2%, PR: 38%).
Median duration of response (mDOR) was 9.7 months (2.7–20.7+ months), and 68%
(n=27/40) of patients responded for ≥ 6 months.1,2


FOR ADULT PATIENTS WITH ES-SCLC WITH DISEASE PROGRESSION ON OR AFTER
PLATINUM-BASED CHEMOTHERAPY


CHOOSE IMDELLTRA™—THE FIRST AND ONLY DLL3-TARGETING BITE® THERAPY1


TO MANAGE AES, INCLUDING CRS AND ICANS, DOSE
MODIFICATIONS OR DISCONTINUATION MAY BE REQUIRED1

Dose reductions are not recommended with IMDELLTRA™1


Based on the IMDELLTRA™ full Prescribing Information, withhold or permanently
discontinue IMDELLTRA™ based on severity of adverse reactions.


CRS may, depending on grade, be managed with supplemental oxygen and IV fluids,
tocilizumab, corticosteroids, vasopressor care, and/or ICU care.

ICANS may, depending on grade, be managed with supportive care, corticosteroids,
ICU care, mechanical ventilation, and/or convulsive treatment.


Go to modifications & AE management strategies >

Please see the IMDELLTRA™ full Prescribing Information for Dosing &
Administration information and additional considerations for AEs, including
BOXED WARNINGS.


AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector
cell–associated neurotoxicity syndrome; ICU, intensive care unit; IV,
intravenous.

Activates a patient’s own T cells to attack DLL3-expressing cells1
DLL3 expression is consistent
across all stages of SCLC3
~ 85%–96%
of patients with SCLC
express DLL32,3,*,†
Delivers breakthrough, durable efficacy in a heavily pretreated population1
Primary endpoint:
ORR
(95% CI: 31–51)1,2,‡,§

(n=40/99)
Secondary endpoint:
mDOR was 9.7 months1,2,‡,§,**
(2.7–20.7+ months)

(n=27/40)

Safety and tolerability evaluated in 187 patients with ES-SCLC1,‡‡

The most common adverse reactions in patients (> 20%) were cytokine release
syndrome (CRS) (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased
appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%),
and nausea (22%)1,‡‡



Important Dosing Information

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 immune effector cell–associated neurotoxicity
syndrome (ICANS).1 Please see the IMDELLTRA™ full Prescribing Information for
Dosing & Administration information and additional considerations for AEs,
including BOXED WARNINGS.

Dose modifications

* Based on a multicenter, international, noninterventional study of 1,050
patients with SCLC, with 1 specimen and evaluable DLL3 expression. DLL3
positivity was based on immunohistochemistry staining with ≥ 25% of tumor cells
that expressed DLL3. DLL3 staining defined as present if tumor cells showed
punctate and/or diffuse cytoplasmic and/or partial or circumferential membranous
staining.3

† Based on the DeLLphi-301, phase 2, open-label study of 157 patients with
ES-SCLC and an evaluable tumor-tissue sample. 151 out of 157 patients were
DLL3-positive (96%). DLL3 expression was defined as detection of expression on
more than 0% of tumor cells.2

‡ Assessed by blinded independent central review (BICR).1

§ Based on 40 patients in the DeLLphi-301 study who received at least 1 dose of
IMDELLTRA™ 10 mg, had measurable disease at baseline per BICR, and responded to
treatment.1

** Based on Kaplan-Meier estimate.1

†† Based on observed duration of response.1

‡‡ Based on the pooled safety population of 187 patients enrolled in DeLLphi-300
and DeLLphi-301 who received IMDELLTRA™ 1 mg on Cycle 1 Day 1 followed by 10 mg
on Days 8, 15, and then Q2W until disease progression or intolerable toxicity.1

PLAN AHEAD FOR YOUR PATIENT’S TREATMENT JOURNEY WITH IMDELLTRA™

Learn about
Amgen® SupportPlus
2L, second line; 3L, third line; AE, adverse event; CI, confidence interval; CR,
complete response; DLL3, delta-like ligand 3; ECOG PS, Eastern Cooperative
Oncology Group performance status; ES-SCLC, extensive-stage small cell lung
cancer; PR, partial response; Q2W, every 2 weeks; RECIST, Response Evaluation
Criteria in Solid Tumors; SCLC, small cell lung cancer.
Close

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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 IMDELLTRA™ was 29.5 days (range: 1 to 154
   days). ICANS can occur several weeks following administration of IMDELLTRA™.
   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™.


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).

Please see IMDELLTRA™ full Prescribing Information, including BOXED WARNINGS.



Reference: IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Ahn M-J, et al. N Engl J Med. 2023;389:2063-2075. 3. Rojo F, et al. Lung Cancer.
2020;147:237-243.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Ahn M-J, et al. N Engl J Med. 2023;389:2063-2075. 3. Ahn M-J, et al. N Engl J
Med. 2023;389(suppl):2063-2075. 4. Shimabukuro-Vornhagen A, et al. J Immunother
Cancer. 2018;6:56. 5. Lee DW, et al. Biol Blood Marrow Transplant.
2019;25:625-638.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Lee DW, et al. Biol Blood Marrow Transplant. 2019;25:625-638.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Ahn M-J, et al. N Engl J Med. 2023;389:2063-2075. 3. Ahn M-J, et al. N Engl J
Med. 2023;389(suppl):2063-2075.

References: 1. Rudin CM, et al. Nat Rev Dis Primers. 2021;7:3. 2. Sabari JK, et
al. Nat Rev Clin Oncol. 2017;14:549-561. 3. National Cancer Institute.
www.cancer.gov. Accessed March 22, 2024. 4. IMDELLTRA™ (tarlatamab-dlle)
prescribing information, Amgen. 5. Leonetti A, et al. Cell Oncol (Dordr).
2019;42:261-273. 6. Rojo F, et al. Lung Cancer. 2020;147:237-243. 7. Ahn M-J, et
al. N Engl J Med. 2023;389:2063-2075.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Ahn M-J, et al. N Engl J Med. 2023;389:2063-2075. 3. ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT05060016. Accessed October 30, 2023.

See more




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

About IMDELLTRA™
 * ES-SCLC
 * Mechanism of action
 * IMDELLTRA™ summary

Clinical Results
 * DeLLphi-301
 * Study design
 * Baseline characteristics
 * Efficacy
 * ORR
 * mDOR
 * mPFS
 * mOS

Safety
 * Common adverse reactions
 * CRS
 * Neurologic toxicity/ICANS

Starting IMDELLTRA™
 * Dosing & administration
 * Dose modifications & management strategies
 * Preparation

Resources & Support
 * Amgen SupportPlus
 * Resources & links
 * For your practice
 * For your patients

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