Tarlatamab-dlle (Imdelltra)

Tarlatamab: tar-LA-tah-mab

Imdelltra: im-DEL-trah

Small cell lung cancer (SCLC)

Imdelltra is approved for:

• Patients with extensive stage small cell lung cancer (ES-SCLC) whose disease got worse during or after treatment with a platinum-based chemotherapy.

Limitations of use

Limitations: Imdelltra should only be administered in a treatment center and by adequately trained healthcare professionals who can ensure proper monitoring and immediate management of side effects associated with the drug.
Age: The safety and efficacy of Imdelltra in patients under 18 years of age have not been established.
Pregnancy/Breastfeeding: Imdelltra is not recommended for use during pregnancy due to potential for harm to the fetus. Patients who can become pregnant are advised to use contraception during treatment with Imdelltra and for 2 months after the last dose of Imdelltra. The risks associated with Imdelltra during breastfeeding are not known and cannot be ruled out. Due to the potential for adverse reactions in the breastfed child, patients are advised not to breastfeed during treatment with Imdelltra and for 2 months after the last dose of Imdelltra.

Antibody therapy

• Bispecific antibody therapy

Targets:

• DLL3 on small cell lung cancer cells
• CD3 receptor on T cells

Imdelltra is a “bispecific antibody”. Antibodies are molecules that can bind to a particular target molecule. Bispecific antibodies are artificially made in the laboratory and can bind to two different targets at the same time. Imdelltra binds to:

• a molecule called delta-like ligand 3 (DLL3) on the surface of cells. DLL3 is present at much higher quantities on the surface of small cell lung cancer cells than normal, healthy cells.
• a molecule called CD3 on the surface of T cells – the primary immune cells involved in killing cancer cells. CD3 is part of the T cell receptor, which is critical to the function of the T cell and is involved in stimulating the T cell to become active.

Because Imdelltra can bind to one molecule on cancer cells and another on T cells at the same time, it acts as a bridge and keeps the T cell in close contact with the cancer cell. By binding CD3 on the T cell, Imdelltra also stimulates the T cell to become activated and kill the cell it is bound to. Bispecific antibodies that direct T cells to kill cancer cells by binding to both cells at the same time are known as bispecific T cell engagers (BiTEs).

Imdelltra is given as an infusion into a vein (intravenous, i.v.) over the course of one hour. To start, a partial “step-up” dose of Imdelltra is given on day 1, followed by a full treatment dose on day 8 and another full treatment dose on day 15. The doses given on days 1 and 8 are accompanied by an infusion of a corticosteroid (dexamethasone) just prior to treatment to reduce the risk of serious reactions to treatment, and each require a 24-hour hospital stay to monitor for such reactions. After each hospital stay, patients should remain within 1 hour of the hospital and in the company of a caregiver for an additional 24 hours. The dose given on day 15 is accompanied by an i.v. infusion of saline given over 4-5 hours. Starting on day 15, treatment is given every 2 weeks, with progressively less monitoring time required in the hospital for subsequent doses.

It is important to keep in mind that each patient’s outcome is individual and may be different from the results found in the clinical studies. In addition, immunotherapy can sometimes take several months to yield an observable treatment response.

Small cell lung cancer

In a clinical study, 99 patients with small cell lung cancer who had previously received treatment with a platinum-containing chemotherapy and at least one other treatment, but whose cancer did not respond or stopped responding were treated with Imdelltra. 40% of patients had a response, with 2% achieving a complete response. Responses lasted for a median of 10 months, with 40% of responses lasting 1 year or longer.

The most common side effects of Imdelltra include cytokine release syndrome, fatigue, fever, a bad taste in the mouth, decreased appetite, pain in the muscles and bones, constipation, reduced blood cells, and nausea. Some side effects, such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome (ICANS), other neurologic toxicities, infections, low white blood cell counts (neutropenia), liver toxicity/damage, and hypersensitivity (an extreme immune reaction to Imdelltra infusion) can become serious or life-threatening. Patients and caregivers receive careful instructions to monitor for signs and symptoms of side effects. These conditions are managed by the healthcare provider.

Cytokine release syndrome (CRS)

CRS is caused by a widespread release of molecules called cytokines, which can cause inflammation and can affect the function of various organs. Cytokines may be released by the T cells to which Imdelltra binds, or by other immune cells in the patient’s body. Signs and symptoms of CRS include fever, low blood pressure, hypoxia (low oxygen levels), fast heartbeat rate, shortness of breath, chills, headache, and elevated liver enzymes. CRS typically occurs within hours or a few days after the first or second step-up dose of Imdelltra in treatment cycle 1. A healthcare provider should be immediately notified if symptoms occur.

Immune effector cell-associated neurotoxicity syndrome (ICANS)

Some of the cytokines released during CRS can result in disruption of the blood–brain barrier, leading to the development of neurological toxicities. ICANS typically occurs within 4 days after the most recent dose of Imdelltra in treatment cycle 1. Symptoms of ICANS include shaking, problems with movement, lethargy, seizures, confusion, and difficulty with speech or handwriting. A healthcare provider should be immediately notified if symptoms occur.

For a more complete list of possible side effects, see the full prescribing information.

Manufacturer

Amgen Inc.

Approval

FDA

Links to drug websites

• US: https://www.Imdelltra.com

Last updated: July 3, 2025

This drug has not been approved in Europe.