OnCo
drugsProductApproved2024🇯🇵

Tarlatamab

The first T-cell engager to improve survival in a common solid tumour, small-cell lung cancer.

Accelerated approval May 2024 (DeLLphi-301, ORR 40%); DeLLphi-304 phase 3 (2025) showed OS 13.6 vs 8.3 months versus chemotherapy in second-line SCLC, converting to full approval. First-line combination with PD-L1 (DeLLphi-305) and limited-stage trials ongoing. CRS in ~50% (mostly grade 1-2); step-up dosing with monitoring.

Loading structure…
|
BiTE-like format (IgG backbone shown for scale)
RCSB PDB

Tarlatamab is a half-life-extended BiTE; intact IgG shown as reference.

How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Mechanism, step by step
auto-advancing · hover to pause

1.One arm binds DLL3 on the tumour cell

Modality
Bispecific T-cell engager (DLL3×CD3)
Mechanism
Half-life-extended BiTE binding DLL3 on tumour and CD3 on T cells.
Brand / code
Imdelltra
Dosing & schedule
Route
IV infusion over 1 hour
Schedule
Step-up: 1 mg on cycle 1 day 1, then 10 mg on day 8 and every 2 weeks thereafter
Dose modifications
Hold for grade 2 CRS/ICANS until resolved; dexamethasone premedication and IV fluids for first two doses
Monitoring
Inpatient monitoring 22-24 h after first two doses; temperature, blood pressure, neurology; ICE score

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. First DLL3 engager for small-cell lung cancer (2024).

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026 (EU MAA under review); accessible only via trials or early access.
NHS England
Not routinely funded

Sources: NICE search: tarlatamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

4top
  1. Nov 2022DesignationUS

    Breakthrough Therapy designation, ES-SCLC after platinum source

  2. 16 May 2024ApprovalUS

    Accelerated approval, ES-SCLC after platinum (DeLLphi-301) source

  3. Jun 2025Filing / dealUS

    Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued source

  4. Dec 2025ApprovalUS

    Full approval based on DeLLphi-304 source

Approvals

RegionYearIndication
US2024Extensive-stage SCLC after platinum chemotherapy

Safety

10top
Toxicity profile
Adverse eventAny gradeGrade 3+
Cytokine release syndrome
DeLLphi-301, n=187
55%
1.6%
Haemoglobin decreased
DeLLphi-301, n=187
58%
5%
Fatigue
DeLLphi-301, n=187
51%
10%
Dysgeusia
DeLLphi-301, n=187
36%
0%
Pyrexia
DeLLphi-301, n=187
36%
0%
Decreased appetite
DeLLphi-301, n=187
34%
2.7%
Musculoskeletal pain
DeLLphi-301, n=187
30%
1.1%
Constipation
DeLLphi-301, n=187
30%
0.5%
Nausea
DeLLphi-301, n=187
22%
1.6%
Neurologic toxicity incl. ICANS
Boxed warning; ICANS in a minority, mostly grade 1-2

Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

2top
Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: appraisal for ES-SCLC after platinum in progress (2026)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-06
28 studies15 recruiting21 Phase 27 Phase 3
Search “Tarlatamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Tarlatamab
intervention: Tarlatamab
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Key papers

1top

Latest papers

top
Literature trend116 papers in the last 12 months+132% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Tarlatamab" OR ABSTRACT:"Tarlatamab" OR TITLE:"Imdelltra" OR ABSTRACT:"Imdelltra") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tarlatamab, not a curated reading list.

Connected

26top