Evidence map›Paper›PMID 41031047›Full record

ArticleJTO clinical and research reports2025

Evaluation of the Safety, Pharmacokinetics, and Antitumor Activity of Tusamitamab Ravtansine in Patients With Nonsquamous NSCLC With High or Moderate Expression of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5.

Anas Gazzah, Charles Ricordel, Antoine Italiano, Byoung Chul Cho, Emiliano Calvo, Dong-Wan Kim, Carole Helissey, Jin-Soo Kim, Maria Vieito Villar, Francois Ghiringhelli and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in JTO clinical and research reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02187848 (A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

NCT02187848 phase1terminatednot on this map

A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

TypeinterventionalSponsorSanofiRan2014 to 2024Enrolled254ConditionsNeoplasm MalignantArmsSAR408701
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. 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

19 authors.

Anas GazzahEarly Drug Development Department, Gustave Roussy, Villejuif, France.
Charles RicordelDepartment of Pulmonology, Centre Hospitalier Universitaire, Université de Rennes 1, Rennes, France.
Antoine ItalianoEarly Phase Trials Unit, Institut Bergonié, Bordeaux, France.
Byoung Chul ChoDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Emiliano CalvoSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Carole HelisseyClinical Research Unit, Military Hospital Bégin, Saint-Mandé, France.
Jin-Soo KimDepartment of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Maria Vieito VillarMedical Oncology Department, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Francois GhiringhelliDepartment of Medical Oncology, Centre Georges-Francois Leclerc, Dijon, France.
Victor MorenoSTART Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain.
Sophie CousinDepartment of Medicine, Institut Bergonié, Bordeaux, France.
Luis Paz-AresH12O-CNIO Lung Cancer Unit, Hospital Universitario 12 de Octubre, Universidad Complutense and Ciberonc, Madrid, Spain.
Nathalie FagniezPharmacokinetics, Dynamics and Metabolism, Sanofi, Chilly-Mazarin, France.
Mustapha ChadjaaClinical Development, Sanofi, Vitry-sur-Seine, France.
Anne-Laure BauchetBiomarkers & Clinical Bioanalysis, Sanofi, Chilly-Mazarin, France.
Christine SouffletClinical Development, Sanofi, Vitry-sur-Seine, France.
Nina MassonIT&M Stats on behalf of Sanofi, Neuilly-sur-Seine, France.
Fabrice BarlesiMultidisciplinary Oncology and Therapeutic Innovations Department, CNRS, INSERM, CRCM, CEPCM CLIP2, Aix Marseille University, Marseille, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Tusamitamab ravtansine is an antibody-drug conjugate targeting cells expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) with a maytansinoid payload, DM4. This phase 1b dose-expansion study (NCT02187848) evaluated its safety, pharmacokinetics, and preliminary antitumor activity in patients with nonsquamous NSCLC (NSq NSCLC). Methods: Patients aged above or equal to 18 years with advanced or metastatic NSq NSCLC, life expectancy more than or equal to 12 weeks, and high (≥2+ intensity in ≥50% of tumor cells) or moderate (≥2+ intensity in 1%-49% of tumor cells) CEACAM5 expression (assessed by immunohistochemistry) received intravenous tusamitamab ravtansine 100 mg/m Results: A total of 64 patients with high and 28 with moderate CEACAM5 expression received a median of 8.0 (1-69) and 4.5 (1-38) treatment cycles, respectively. High expressors had 13 confirmed partial responses and 28 stable diseases (objective response rate, 20.3%; 95% confidence interval [CI]: 12.3%-31.7%, Conclusions: Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.

Indexed as

Antibody-drug conjugateCarcinoembryonic antigen-related cell adhesion molecule 5Non–small cell lung cancerPhase 1 studyTusamitamab ravtansine

Identifiers

PMID41031047
PMCPMC12478256

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.