Imdelltra (tarlatamab) is a bispecific T-cell engager targeting DLL3-CD3. It received accelerated approval from the U.S. FDA in 2024 for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has progressed following platinum-based chemotherapy.

How to Use Imdelltra (Tarlatamab)

Dosing Regimen

Stepwise Dose Escalation: To reduce the risk of cytokine release syndrome (CRS), a stepwise dosing approach is required:

Cycle 1: 1 mg on Day 1, 10 mg on Day 8, and 10 mg on Day 15.

Subsequent Cycles: Maintenance treatment with 10 mg every 2 weeks until disease progression or unacceptable toxicity occurs.

Infusion Requirements: Administer via intravenous infusion over 1 hour at a constant rate using an infusion pump. The first dose must be administered in a healthcare facility equipped to manage CRS.

Premedication and Monitoring

Administer 8 mg of dexamethasone intravenously (or an equivalent agent) within 1 hour prior to infusion.

Immediately after the infusion, administer 1 liter of normal saline intravenously, to be completed within 4-5 hours.

Monitoring Requirements

Cycle 1, Days 1 and 8: In-hospital monitoring for 22-24 hours after infusion. A caregiver is required within 48 hours, and the patient must reside within 1 hour of a healthcare facility.

Cycle 1, Day 15 and Subsequent Cycles: Observe for 6-8 hours after infusion (Cycle 2), 3-4 hours (Cycles 3-4), or 2 hours (starting from Cycle 5).

Dose Adjustments for Imdelltra (Tarlatamab)

Dose Adjustments for CRS

Grade 1-2 CRS: Hold administration until symptoms resolve, then resume according to the original schedule.

Grade 3 CRS: Hold administration and initiate hospital care (e.g., ICU support). After recovery, reinitiate treatment with stepwise dose escalation.

Grade 4 CRS or Recurrent Grade 3 CRS: Discontinue treatment permanently.

Dose Adjustments for Neurotoxicity (Including ICANS)

Grade 1-2 Neurotoxicity: Hold administration until symptoms resolve, then resume treatment.

Grade 3 Neurotoxicity: Hold administration and conduct a neurological evaluation. Discontinue treatment permanently if no improvement occurs within 7 days or if symptoms recur.

Grade 4 Neurotoxicity: Discontinue treatment permanently.

Use in Special Populations for Imdelltra (Tarlatamab)

Pregnancy and Lactation

Pregnant Women: May cause fetal harm. Confirm pregnancy status before initiating treatment. Effective contraception is required during treatment and for 2 months after the last dose.

Lactation: Breastfeeding is prohibited during treatment and for 2 months after discontinuing treatment.

Hepatic and Renal Impairment

Mild to Moderate Renal Impairment or Mild Hepatic Impairment: No dose adjustment is needed.

Severe Renal Impairment or Moderate to Severe Hepatic Impairment: The efficacy is unknown; careful assessment is required.

Pediatric Use

The efficacy of Imdelltra in patients under 18 years of age has not been established.