Evidence map›Paper›PMID 34589982›Full record

ArticleJTO clinical and research reports2021

Daratumumab Plus Atezolizumab in Previously Treated Advanced or Metastatic NSCLC: Brief Report on a Randomized, Open-Label, Phase 1b/2 Study (LUC2001 JNJ-54767414).

Rathi N Pillai, Suresh S Ramalingam, Meena Thayu, Patricia Lorenzini, Diana A Alvarez Arias, Christopher Moy, Natalie Hutnick, Roland Knoblauch, Huaibao Feng, Colleen Kane and 4 more

Abstract read
In one paragraph

Article in JTO clinical and research reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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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

14 authors.

Rathi N PillaiDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Atlanta, Georgia.
Suresh S RamalingamDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Atlanta, Georgia.
Meena ThayuJanssen Research & Development, LLC, Titusville, New Jersey.
Patricia LorenziniJanssen Research & Development, LLC, Spring House, Pennsylvania.
Diana A Alvarez AriasJanssen Research & Development, LLC, Spring House, Pennsylvania.
Christopher MoyJanssen Research & Development, LLC, Spring House, Pennsylvania.
Natalie HutnickJanssen Research & Development, LLC, Spring House, Pennsylvania.
Roland KnoblauchJanssen Research & Development, LLC, Raritan, New Jersey.
Huaibao FengJanssen Research & Development, LLC, Raritan, New Jersey.
Colleen KaneJanssen Research & Development, LLC, Spring House, Pennsylvania.
Leora HornDivision of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, Tennessee.
Martin ReckDepartment of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research, Grosshansdorf, Germany.
Santiago PonceDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
LUC2001 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe programmed death-ligand 1 inhibitor atezolizumab improves progression-free survival (PFS) and overall survival (OS) for patients with previously treated advanced NSCLC. Preclinical studies indicate that targeting CD38-positive cells with daratumumab may synergistically enhance atezolizumab's antitumor activity by increasing the effector T-cell activity.

methodsThis phase 1b-2 study included a safety run-in (one cycle of daratumumab plus atezolizumab) and randomized phases (daratumumab plus atezolizumab versus atezolizumab alone). The primary objective of the randomized phase was to compare overall response rates. The secondary objectives included evaluations of safety, clinical benefit rate (stable disease or better), PFS, OS, and pharmacokinetics.

resultsIn total, 99 patients were enrolled (safety run-in, n = 7; randomized, n = 46 per arm). In the randomized phase, the overall response rate was 4.3% for daratumumab plus atezolizumab and 13.0% for atezolizumab alone (OR: 0.30; 95% confidence interval: 0.03-1.92). The respective clinical benefit rates were 52.2% and 43.5%. No improvements were observed in the median PFS or median OS for combination therapy. The study was terminated because of the limited efficacy of daratumumab plus atezolizumab.

conclusionsDaratumumab plus atezolizumab therapy did not improve efficacy versus atezolizumab monotherapy for patients with previously treated advanced NSCLC.

Indexed as

AtezolizumabCombination immunotherapyDaratumumabNon‒small cell lung cancer

Identifiers

PMID34589982
PMCPMC8474375

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Registered trials

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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.