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Tasquinimod improved PFS in metastatic castration-resistant prostate cancer
Tasquinimod prolonged survival in men with minimally symptomatic, metastatic castration-resistant prostate cancer compared with placebo, according to results of a randomized, phase 2 study.
Results suggest the survival advantage was particularly apparent among men with skeletal metastases.
The study included 201 men. Researchers assigned 134 of them to tasquinimod (Active Biotech), an oral immunomodulatory, anti-angiogenic and anti-metastatic novel agent. The other 67 men were assigned placebo; however, 41 of them crossed over to treatment with tasquinimod during the study.
Median follow-up was 37 months, during which time 111 patients died.
Median OS was 33.4 months in the tasquinimod group vs. 30.4 months in the placebo group.
Among the 136 men with bone metastases, median OS was longer in those assigned tasquinimod (34.2 months vs. 27.1 months).
Results of a multivariable analysis favored tasquinimod for PFS (HR=0.52; 95% CI, 0.35-0.78) and OS (HR=0.64; 95% CI, 0.42-0.97).
Tasquinimod also improved time to symptomatic progression (HR=0.42; P=.039).
In additional biomarker analyses, tasquinimod induced favorable outcomes on bone alkaline phosphatase and lactate dehydrogenase. Results showed transient induction of inflammatory biomarkers, VEGF-A and thrombospondin-1 levels with tasquinimod.
Baseline levels of thrombospondin-1 below the median were associated with treatment benefit.
Toxicities were mild and tended to improve with time, researchers said.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.