Imdelltra

Extensive-stage small cell lung cancer (ES-SCLC) in adults with disease progression on or after platinum-based chemotherapy.

Step-up dosing (Cycle 1): Day 1: 1 mg IV, Day 8: 10 mg IV, Day 15: 10 mg IV
Subsequent cycles (Cycle 2+): 10 mg IV on Day 1 of each 14-day cycle
Infusion time: Over 1 hour
Hospitalization: 24 hours after Day 1 and Day 8 of Cycle 1 for CRS monitoring
Pre-medication: Dexamethasone 8 mg IV before each dose in Cycle 1; subsequent cycles per clinical judgment

Injection: 10 mg per single-dose vial (lyophilized powder for reconstitution)

None listed.

• Cytokine Release Syndrome (CRS): Occurred in 53% (1% Grade 3+). Median onset: 10 hours after Cycle 1 Day 1. Pre-medicate with dexamethasone. Manage with tocilizumab per CRS grading.
• Neurologic Toxicity (ICANS): Immune effector cell-associated neurotoxicity in 10% (3% Grade 3+). Includes confusional state, somnolence, dysarthria, aphasia. Monitor and withhold for Grade ≥2.
• Infections: Serious infections reported. Monitor and treat promptly.
• Hepatotoxicity: ALT/AST elevations reported. Monitor LFTs.

Cytokine release syndrome (53%), fatigue (41%), pyrexia (35%), dysgeusia (26%), constipation (25%), decreased appetite (23%), musculoskeletal pain (22%), nausea (21%), anemia (18%), rash (16%), lymphopenia (14%), hypotension (14%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tarlatamab is a bispecific T-cell engager (BiTE) antibody construct that binds simultaneously to DLL3 (delta-like ligand 3) on tumor cells and CD3 on T cells. DLL3 is an inhibitory Notch ligand that is aberrantly expressed on the surface of SCLC cells but has minimal expression on normal adult tissues. By bridging DLL3-positive tumor cells with cytotoxic T cells, tarlatamab activates T cells to release perforin and granzymes, inducing targeted tumor cell lysis independent of MHC recognition.

Half-life: approximately 13-18 days at 10 mg dose. Steady-state reached by approximately Cycle 4. Non-linear pharmacokinetics at lower doses with target-mediated drug disposition. Volume of distribution approximately 4-5 L.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• DeLLphi-301 — Tarlatamab in relapsed/refractory SCLC after ≥2 prior lines. Phase II, n=220.
  🔬 NCT05060016 ↗ 📄 Primary Publication ↗

Imdelltra has FDA-approved indications across the following cancer types covered on PipelineEvidence: