1. Academic Validation
  2. Efficacy and safety of dilpacimab (ABT-165) versus bevacizumab plus FOLFIRI in metastatic colorectal cancer: a phase II study

Efficacy and safety of dilpacimab (ABT-165) versus bevacizumab plus FOLFIRI in metastatic colorectal cancer: a phase II study

  • Future Oncol. 2022 Sep;18(27):3011-3020. doi: 10.2217/fon-2021-1603.
John H Strickler 1 Antonio Cubillo 2 Jin-Tung Liang 3 Marc Matrana 4 Mark Kozloff 5 Thomas Lowe 6 Martha Blaney 7 Mohammad Sahtout 8 Louie Naumovski 8 Zev A Wainberg 9
Affiliations

Affiliations

  • 1 Duke University School of Medicine, Durham, NC 27710, USA.
  • 2 Centro Integral Oncológico Clara Campal HM CIOCC, Madrid, Spain & Universidad Camilo José Cela, Madrid, 28050, Spain.
  • 3 National Taiwan University Hospital, Taipei, 28692, Taiwan.
  • 4 Ochsner Clinic Foundation-New Orleans, New Orleans, LA 70121, USA.
  • 5 University of Chicago Medical Center/Ingalls Memorial Hospital, Chicago, IL 60637, USA.
  • 6 Torrance Health Association (DBA), Torrance Memorial Physician Network/Cancer Care, Torrance, CA 90505, USA.
  • 7 AbbVie Inc., North Chicago, IL 60064, USA.
  • 8 AbbVie Inc., South San Francisco, CA 94080, USA.
  • 9 UCLA Health, University of California Los Angeles, Los Angeles, CA 90001, USA.
Abstract

Aim: This phase II study investigated safety and efficacy of dilpacimab or bevacizumab plus FOLFIRI in patients with previously treated metastatic colorectal Cancer (mCRC). Materials & methods: Overall, 66 patients were treated (n = 34 dilpacimab + FOLFIRI; n = 32 bevacizumab + FOLFIRI). Progression-free survival, overall survival, response rates and tolerability were assessed. Results: Median progression-free survival for dilpacimab + FOLFIRI compared with bevacizumab + FOLFIRI was 3.78 months (95% CI: 2.07-7.20) versus 7.36 months (95% CI: 5.68-10.55) (hazard ratio: 3.57; 95% CI: 1.57-8.11; stratified). Median overall survival: 7.95 months for dilpacimab + FOLFIRI; not reached for bevacizumab + FOLFIRI. Objective response rates: 5.6% for dilpacimab + FOLFIRI and 14.7% for bevacizumab + FOLFIRI. Patients treated with dilpacimab + FOLFIRI experienced serious treatment-related adverse events (n = 4; 11.8%), including one case of intestinal perforation leading to death; none were reported for bevacizumab + FOLFIRI. Conclusion: Treatment with dilpacimab + FOLFIRI was not well tolerated and did not provide clinical benefit to patients with mCRC compared with bevacizumab + FOLFIRI. Clinical Trial Registration: NCT03368859 (Clinicaltrials.gov).

Keywords

DLL4; FOLFIRI; bevacizumab; colorectal cancer; dilpacimab.

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