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  3. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study

Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Ahn, MJ
  • Tanaka, K
  • Paz-Ares, L
  • Cornelissen, R
  • Girard, N
  • Pons-Tostivint, E
  • Baz, DV
  • Sugawara, S
  • Cobo, M
  • Perol, M
  • Mascaux, C
  • Poddubskaya, E
  • Kitazono, S
  • Hayashi, H
  • Hong, MH
  • Felip, E
  • Hall, R
  • Brungs, D
  • Lu, S
  • Garassino, M
  • Chargualaf, M
  • Zhang, Y
  • Howarth, P
  • Uema, D
  • Lisberg, A
  • Sands, J
  • TROPION-Lung01 Trial Investigators

Grupos

Abstract

PURPOSEThe randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non-small cell lung cancer (NSCLC).METHODSPatients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points.RESULTSIn total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade >= 3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8.8% and 4.1% of patients, in the Dato-DXd and docetaxel groups, respectively.CONCLUSIONDato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. OS showed a numerical benefit but did not reach statistical significance. No unexpected safety signals were observed.

Datos de la publicación

ISSN/ISSNe:
0732-183X, 1527-7755

JOURNAL OF CLINICAL ONCOLOGY  LIPPINCOTT WILLIAMS & WILKINS

Tipo:
Article
Páginas:
260-272
PubMed:
39250535
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
9,378 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 249

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Keywords

  • Adult; Aged; Aged, 80 and over; Carcinoma, Non-Small-Cell Lung; Docetaxel; Female; Humans; Immunoconjugates; Lung Neoplasms; Male; Middle Aged; Progression-Free Survival; datopotamab deruxtecan; docetaxel; antibody conjugate; docetaxel; adult; advanced cancer; Article; cancer grading; computer assisted tomography; controlled study; disease exacerbation; drug efficacy; drug safety; febrile neutropenia; female; human; interstitial lung disease; leukopenia; major clinical study; male; metastasis; middle aged; neutropenia; non small cell lung cancer; nuclear magnetic resonance imaging; oral mucositis; overall survival; phase 3 clinical trial; pneumonia; practice guideline; progression free survival; randomized controlled trial; stomatitis; treatment duration; aged; clinical trial; comparative study; drug therapy; lung tumor; mortality; multicenter study; non small cell lung cancer; pathology; very elderly

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