Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171)

J Thorac Oncol. 2023 Jun;18(6):813-819. doi: 10.1016/j.jtho.2023.02.003. Epub 2023 Feb 24.

Abstract

Immune checkpoint inhibitors have activity in mesothelioma. IND.227 was a phase 2 trial (120 patients planned) comparing progression-free survival of standard platinum and pemetrexed (CP) versus CP + pembrolizumab (pembro) versus pembro. Accrual to the pembro arm was discontinued on the basis of interim analysis (IA-16 wk disease control rate). CP + pembro was tolerable, with progression-free survival similar between arms and median survival and overall response rate higher than those of CP alone (19.8 mo [95% confidence interval or CI: 8.4-41.36] versus 8.9 mo [95% CI: 5.3-12.8] and 47% [95% CI: 24%-71%] versus 19% [95% CI: 5%-42%], respectively). The subsequent phase 3 trial has completed accrual; results are expected in 2023.

Keywords: Chemoimmunotherapy; Mesothelioma; Phase II; Randomized.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Canada
  • Humans
  • Lung Neoplasms* / pathology
  • Mesothelioma* / pathology
  • Mesothelioma, Malignant*
  • Pemetrexed / pharmacology
  • Pemetrexed / therapeutic use
  • Pleural Neoplasms* / pathology

Substances

  • pembrolizumab
  • Pemetrexed