Survival data from a phase II PCCTC trial of single agent tasquinimod (NCT00560482) further support the development of this novel drug in men with minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Results published online in the journal Clinical Cancer Research demonstrate a long-term survival benefit, measured by progression-free survival (PFS) and overall survival (OS), as well as a positive impact on prognostic prostate cancer biomarkers.
The study, led by Dr. Andrew J. Armstrong of Duke Cancer Institute and the Duke Prostate Center, randomized 134 men to receive tasquinimod and 67 men to receive placebo. In addition, 41 men who initially received placebo crossed over to the tasquinimod arm. With a median follow-up time of 37 months, a statistically significant survival advantage was shown: the median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall, and 34.2 versus 27.1 months in men with bone metastases (n = 136), respectively. Investigators also reported results from their exploratory biomarker analyses. Here, measurements of serum levels of bone alkaline phosphatase (BAP) and the metabolic enzyme lactate dehydrogenase (LDH) suggest tasquinimod actively delays tumor progression in bone. Side effects, consistent with earlier reports, included mild-to-moderate gastrointestinal events, muscle and joint pain, and fatigue.
Tasquinimod is currently in phase III development (NCT01234311) for asymptomatic to mildly symptomatic patients with mCRPC in a trial led by PCCTC colleague, Dr. Michael Carducci at Johns Hopkins Kimmel Cancer Center in Baltimore. In addition, a European trial (NCT01732549) is investigating the use of tasquinimod in patients with mCRPC who are not progressing after treatment with first-line docetaxel-based chemotherapy.
Source: Armstrong AJ, Häggman M, Stadler WM, et al. Long-term Survival and Biomarker Correlates of Tasquinimod Efficacy in a Multicenter Randomized Study of Men with Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2013 Nov 19. [Epub ahead of print] PubMed PMID: 24255071.