Evidence map›Paper›PMID 40261494›Full record

ArticleClinical pharmacokinetics2025

Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer.

Stephanie Kong, Mukul Minocha, Po-Wei Chen, Pablo Martinez, Erik S Anderson, Amanda Parkes, Brett E Houk, Chih-Wei Lin

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05060016 (A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05060016 phase2active not recruitingnot on this map

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

TypeinterventionalSponsorAmgenRan2021 to 2027Enrolled222ConditionsRelapsed/Refractory Small Cell Lung CancerArmsTarlatamab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Tarlatamab Exposure-Efficacy and Exposure-Safety Relationships to Inform Dose Selection in Patients with Small Cell Lung Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Stephanie KongClinical Pharmacology Modeling and Simulation at Amgen, Thousand Oaks, USA.
Mukul MinochaClinical Pharmacology Modeling and Simulation at Amgen, Thousand Oaks, USA.
Po-Wei ChenClinical Pharmacology Modeling and Simulation at Amgen, Thousand Oaks, USA.
Pablo MartinezClinical Development Oncology at Amgen, Thousand Oaks, USA.
Erik S AndersonClinical Development Oncology at Amgen, Thousand Oaks, USA.
Amanda ParkesClinical Development Oncology at Amgen, Thousand Oaks, USA.
Brett E HoukClinical Pharmacology Modeling and Simulation at Amgen, Thousand Oaks, USA.
Chih-Wei LinClinical Pharmacology Modeling and Simulation at Amgen, Thousand Oaks, USA. clin04@amgen.com.ORCID 0009-0002-3126-3981

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveTarlatamab is a first in class, half-life extended delta-like ligand 3 (DLL3) directed bispecific T-cell engager (BiTE®) immunotherapy that has shown durable efficacy in patients with previously treated small cell lung cancer (SCLC). The purpose of this analysis was to develop a population pharmacokinetic (PK) model for tarlatamab.

methodsThis analysis includes data from 420 patients with previously treated small cell lung cancer (8509 samples) pooled across the Phase 1 DeLLphi-300 study (dose range 0.003-100 mg every 2 weeks and 200 mg every 3 weeks) and Phase 2 DeLLphi-301 study (10 mg and 100 mg every 2 weeks). The data were analyzed using a nonlinear-mixed effects modeling approach implemented in NONMEM (v7.5) software and validated using standard statistical approaches. The effects of intrinsic and extrinsic factors on PK parameters and exposures of tarlatamab were evaluated, and the impact of identified covariates were further assessed using simulations.

resultsTarlatamab serum concentration data were best described by a two-compartment model with linear elimination. Tarlatamab clearance (CL) and central volume of distribution (V

conclusionsThe pharmacokinetics of tarlatamab was well-described by a two-compartment model with linear elimination. No clinically significant differences were observed on the basis of age, sex, bodyweight, race, ethnicity, estimates of renal and hepatic function, prior lines of therapy, baseline disease status, or emergence of ADA. These results support that no dose adjustment is required on the basis of any of the evaluated covariates.

Indexed as

Antibodies, BispecificAntineoplastic AgentsLung NeoplasmsModels, BiologicalSmall Cell Lung CarcinomaAdultAgedAged, 80 and overClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDose-Response Relationship, DrugFemaleHalf-LifeHumansIntracellular Signaling Peptides and ProteinsMaleAMG 757Antibodies, BispecificAntineoplastic AgentsDLL3 protein, humanIntracellular Signaling Peptides and ProteinsMembrane ProteinsOrganic Chemicals

Identifiers

PMID40261494

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.