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Updated: Feb 10, 2026

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Apatorsen plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial carcinoma (Borealis-2)

Jonathan E Rosenberg1, Noah M Hahn2, Meredith M Regan3

  • 1Memorial Sloan Kettering Cancer Center, New York, NY, USA.

British Journal of Cancer
|May 17, 2018
PubMed
Abstract

Insights

Adding apatorsen to docetaxel showed improved overall survival in patients with metastatic urothelial carcinoma (mUC) who relapsed after chemotherapy. This combination therapy met its primary endpoint in a phase II trial.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Investigating apatorsen, an antisense oligonucleotide targeting Hsp27 expression, in combination with docetaxel.
  • Focusing on patients with metastatic urothelial carcinoma (mUC) resistant to platinum-based chemotherapy.

Purpose of the Study:

  • To assess the efficacy and safety of apatorsen plus docetaxel versus docetaxel alone in platinum-refractory mUC.
  • To evaluate overall survival (OS) as the primary endpoint.

Main Methods:

  • A multicenter, randomized phase II clinical trial.
  • Patients received either apatorsen plus docetaxel (A/D) or docetaxel alone.
  • Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed.

Main Results:

  • A/D demonstrated improved OS compared to docetaxel alone (HR: 0.80, P=0.0784), with median survival of 6.4 vs 5.9 months.
  • PFS and ORR were comparable between the two arms.
  • Increased incidence of sepsis and urinary tract infections observed in the A/D arm.
  • Patients with lower baseline Hsp27 levels (<5.7 ng/mL) or a decrease in Hsp27 showed greater benefit from A/D.

Conclusions:

  • The combination of apatorsen and docetaxel (A/D) met its predefined overall survival endpoint in platinum-refractory metastatic urothelial carcinoma.
  • The study is hypothesis-generating, suggesting a potential benefit of A/D in this patient population.
  • Further investigation is warranted to confirm these findings and guide clinical practice.

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