Evidence map›Paper›PMID 31506387›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study.

Daniel Morgensztern, Benjamin Besse, Laurent Greillier, Rafael Santana-Davila, Neal Ready, Christine L Hann, Bonnie S Glisson, Anna F Farago, Afshin Dowlati, Charles M Rudin and 6 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 198 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
198citing papers in PubMed, 5 pooled it
17.9field-weighted citation impact, top 1% of its field
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.

NCT02674568 phase2completednot on this map

An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

TypeinterventionalSponsorAbbVieRan2016 to 2018Enrolled342ConditionsSmall Cell Lung CancerArmsRovalpituzumab tesirine
NCT03061812 phase3completednot on this map

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

TypeinterventionalSponsorAbbVieRan2017 to 2020Enrolled444ConditionsSmall Cell Lung CancerArmsRovalpituzumab tesirine, Topotecan, Dexamethasone
3 · Its place in the literature

Who cites it

198 citing papers in PubMed, 5 syntheses or guidelines pooled it, 316 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnnals of oncology : official journal of the European Society for Medical Oncology · 2021
    Guideline
  5. Pooled it
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Delta-like Ligand 3-DirectedJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  12. Article
  13. Review
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138 more citing papers are in PubMed but not listed here.

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

16 authors at 14 institutions in 3 countries.

Daniel MorgenszternWashington University, St. Louis, Missouri. danielmorgensztern@wustl.edu.
Benjamin BesseGustave Roussy, Villejuif, France.
Laurent GreillierAssistance Publique-Hôpitaux de Marseille, Aix Marseille University, Marseille, France.ORCID 0000-0002-5807-9503
Rafael Santana-DavilaUniversity of Washington, Seattle, Washington.
Neal ReadyDuke University Medical Center, Durham, North Carolina.
Christine L HannJohns Hopkins University, Baltimore, Maryland.
Bonnie S GlissonMD Anderson Cancer Center, Houston, Texas.
Anna F FaragoMassachusetts General Hospital, Boston, Massachusetts.
Afshin DowlatiUniversity Hospitals Case Medical Center, Cleveland, Ohio.
Charles M RudinMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-5204-3465
Sylvestre Le MoulecInstitut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, France.
Satwant LallyAbbVie Stemcentrx, South San Francisco, California.
Sreeni YalamanchiliAbbVie Stemcentrx, South San Francisco, California.
Jürgen WolfCenter for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.
Ramaswamy GovindanWashington University, St. Louis, Missouri.
David P CarboneOhio State University, Columbus, Ohio.
ChemoCentryx (United States) · USWashington University in St. Louis · USAix-Marseille Université · FRDuke Medical Center · USInstitut Bergonié · FRJohns Hopkins University · USMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USOhio University · USThe University of Texas MD Anderson Cancer Center · USUniversité Paris-Sud · FRUniversity Hospital Cologne · DEUniversity Hospitals Cleveland Medical Center · USUniversity of Washington · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeAlthough extensive-stage small-cell lung cancer (SCLC) is highly responsive to first-line therapy, virtually all patients develop resistance with short survival. Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate targeting delta-like 3 protein (DLL3). This open-label, single-arm, phase II study (TRINITY) assessed safety and efficacy of Rova-T in patients with DLL3-expressing SCLC in the third-line and beyond (3L+) setting. PATIENTS AND

methodsPatients with DLL3-expressing SCLC (determined by mouse antibody immunohistochemistry [IHC] assay), and ≥2 prior regimens, received 0.3 mg/kg Rova-T once every 6 weeks for two cycles. During study, a rabbit antibody IHC assay was developed and used for the final analysis, with DLL3-positive and DLL3-high defined as ≥25% and ≥75% of tumor cells positive for DLL3, respectively. The primary endpoints were objective response rate (ORR) and overall survival (OS).

resultsAmong 339 patients enrolled, 261 (77%) had two prior lines of therapy and 78 (23%) had ≥3. DLL3-high and DLL3-positive tumors by rabbit IHC were seen in 238 (70%) and 287 (85%) patients, respectively. The remaining 52 (15%) were DLL3-negative only by rabbit IHC or had missing results. ORR was 12.4%, 14.3%, and 13.2% in all, DLL3-high, and DLL3-positive patients, respectively. Median OS was 5.6 months in all patients and 5.7 months in DLL3-high patients. The most common adverse events (AE) were fatigue, photosensitivity reaction, and pleural effusion. Grade 3-5 AEs were seen in 213 (63%) patients.

conclusionsRova-T is the first targeted agent in SCLC to use DLL3, a novel biomarker. However, results demonstrate modest clinical activity in 3L+ SCLC, with associated toxicities.

Indexed as

Salvage TherapyAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedBenzodiazepinonesDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansImmunoconjugatesIntracellular Signaling Peptides and ProteinsLung NeoplasmsMaleMembrane ProteinsMiddle AgedAntibodies, Monoclonal, HumanizedBenzodiazepinonesDLL3 protein, humanImmunoconjugatesIntracellular Signaling Peptides and ProteinsMembrane Proteinsrovalpituzumab tesirine

Identifiers

PMID31506387
PMCPMC7105795
OpenAlexW2973098277

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.