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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).

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About IMDELLTRA®

Explore appropriate use of IMDELLTRA®
in patients with ES-SCLC.

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About IMDELLTRA®

Explore appropriate use of
IMDELLTRA®

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IMDELLTRA® clinical
results

Examine data from the
DeLLphi-301 study

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IMDELLTRA® in practice

Discover expert insights on the use
of IMDELLTRA® in clinical practice

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For adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy

Choose IMDELLTRA®—the first and only DLL3-targeting Bispecific T-cell Engager (BiTE®) therapy1

IMDELLTRA® is an innovative approach to treating 2L+ ES‑SCLC. This BiTE® therapy activates the patient’s own T cells to attack DLL3-expressing cells1

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Tarlatamab-dlle is an NCCN Category 1, Preferred subsequent treatment option for adult patients (PS 0‑2) with ES-SCLC with disease progression on or after platinum-based chemotherapy2National Comprehensive Cancer Network® (NCCN®)

DISCOVER MORE ABOUT IMDELLTRA®

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

2L, second line; DLL3, delta-like ligand 3; ES-SCLC, extensive-stage small cell lung cancer; NCCN, National Comprehensive Cancer Network®; PS, performance status.

References: 1. IMDELLTRA® (tarlatamab-dlle) prescribing information, Amgen. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer V.4.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 24, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

Dr Byeong Yoon meets with a multidisciplinary group of healthcare professionals to explore the integration of IMDELLTRA® into clinical practice for patients with ES-SCLC.

ES-SCLC, extensive-stage small cell lung cancer.

EXPLORE MORE ABOUT IMDELLTRA®
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IMDELLTRA® in practice

Discover expert insights on the use of IMDELLTRA® in clinical practice for patients with ES-SCLC.

ES-SCLC, extensive-stage small cell lung cancer.

DeLLphi-301 study design:

Phase 2, open-label, multicenter, multi-cohort clinical trial evaluating IMDELLTRA® 10 mg in 99 patients with 3L+ ES-SCLC, with disease progression after previous treatment with platinum‑based chemotherapy and at least one other line of prior therapy. The primary outcome measure was ORR. Select secondary outcome measures included DOR, PFS, OS, and AEs during the treatment period.1,2

Breakthrough, durable efficacy with sustained responses1

Primary endpoint:
Overall response rate
(ORR)1,2,*,†

40%

(n=40/99) (95% CI: 31–51)

2% (n=2/99) had a complete response (CR)

38% (n=38/99) had a partial response (PR)

Select secondary endpoint:
Median duration of response
(mDOR)1,2,*,‡,§

9.7months

(2.7–20.7+ months)

68% (n=27/40) responded for ≥ 6 months**

Assessed by blinded independent central review (BICR).1

Based on 99 patients in the DeLLphi-301 study who received at least 1 dose of IMDELLTRA® 10 mg and had measurable disease at baseline per 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

Median based on Kaplan-Meier estimate.1

Based on observed duration of response.1

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,††

Permanent discontinuation of IMDELLTRA® due to adverse reactions occurred in 7% of patients1,††

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

Administer IMDELLTRA® as a 1-hour IV infusion, according to the step-up dosing schedule, in an appropriate healthcare setting until disease progression or unacceptable toxicity1

Administer 1 mg step-up dose on Cycle 1, Day 1 to reduce the incidence and severity of CRS, followed by a 10 mg dose on Days 8 and 15 and every 2 weeks thereafter1

Dosing icon
  • For Cycle 1, administer recommended concomitant medications before and after IMDELLTRA® infusions1
  • 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
  • Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be monitored 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 setting1
  • 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 caregiver1
  • Prior to administration of IMDELLTRA®, evaluate complete blood count, liver enzymes, and bilirubin before each dose, and as clinically indicated1
  • Ensure patients are well hydrated prior to administration of IMDELLTRA®1

Please see additional information in the Dosage and Administration section of the full Prescribing Information.

LEARN MORE ABOUT IMDELLTRA®

3L, third line; AE, adverse event; CI, confidence interval; DOR, duration of response; ES-SCLC, extensive-stage small cell lung cancer; IV, intravenous; OS, overall survival; PFS, progression-free survival; Q2W, every two weeks.

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

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IMDELLTRA® clinical results

Examine data from the DeLLphi-301 study evaluating IMDELLTRA® in ES-SCLC.

ES-SCLC, extensive-stage small cell lung cancer.

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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®.

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