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Tasquinimod: a novel drug in advanced prostate cancer

Susanne Osanto1, Hendrik van Poppel, Jacobus Burggraaf

  • 1Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands. s.osanto@lumc.nl

Future Oncology (London, England)
|August 29, 2013
PubMed

Insights

Tasquinimod shows promise in treating minimally symptomatic castration-resistant prostate cancer (CRPC) by delaying disease progression and metastasis. Further Phase III trials are underway to confirm its efficacy as a novel therapy for CRPC patients.

Area of Science:

  • Oncology
  • Pharmacology
  • Urology

Background:

  • Castration-resistant prostate cancer (CRPC) remains a significant challenge, particularly in its minimally symptomatic stages.
  • Tasquinimod, an oral quinolone-3-carboxamide, exhibits preclinical anti-tumor activity.
  • The precise anti-tumor mechanisms of tasquinimod, including potential inhibition of angiogenesis and immunomodulation, require further elucidation.

Purpose of the Study:

  • To evaluate the efficacy and safety of tasquinimod in patients with minimally symptomatic castration-resistant prostate cancer (CRPC).
  • To assess tasquinimod's impact on disease progression and metastasis in CRPC.
  • To establish the maximum tolerated dose and side effect profile of tasquinimod.

Main Methods:

  • Phase I studies determined the maximum tolerated dose of oral tasquinimod (0.5-1 mg daily) in CRPC patients.
  • A Phase II randomized trial compared tasquinimod to placebo in asymptomatic or minimally symptomatic, chemotherapy-naive metastatic CRPC (mCRPC) patients.
  • A large, randomized, double-blind, placebo-controlled Phase III trial has been initiated to validate Phase II findings, with progression-free survival as the primary endpoint.

Main Results:

  • Tasquinimod demonstrated anti-tumor activity with a manageable side effect profile in clinical studies.
  • Phase I studies identified dose-limiting toxicities including amylase elevation and sinus tachycardia.
  • The Phase II trial showed a significant improvement in median progression-free survival for tasquinimod-treated patients (7.6 months vs. 3.3 months for placebo; p = 0.0042).

Conclusions:

  • Tasquinimod exhibits promising clinical activity in minimally symptomatic mCRPC patients, significantly improving progression-free survival.
  • The compound has a mild-to-moderate side effect profile, with dose-limiting toxicities identified.
  • Positive Phase II results warrant further investigation in a large Phase III trial to potentially establish tasquinimod as a new therapy for minimally symptomatic mCRPC.

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