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Updated: Mar 19, 2026
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic
Cora Sternberg1, Andrew Armstrong1, Roberto Pili1
1Cora Sternberg, San Camillo Forlanini Hospitals, Rome, Italy; Andrew Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Roberto Pili, Indiana University School of Medicine, Indianapolis, IN; Siobhan Ng, St John of God Medical Centre, Subiaco, Western Australia, Australia; Robert Huddart, Royal Marsden Hospital, Sutton; Nicholas James, Queen Elizabeth Hospital, Birmingham; Simon Chowdhury, Guy's Hospital and Sarah Cannon Research UK, London, United Kingdom; Neeraj Agarwal, University of Utah, Salt Lake City, UT; Denis Khvorostenko, Leningrad Regional Oncology Dispensary, St Petersburg, Russia; Olexiy Lyulko, Zaporizhzhya Regional Clinical Hospital, Zaporizhzhya, Ukraine; Arija Brize, Riga Eastern Clinical University Hospital, Riga, Latvia; Nicholas Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Rémy Delva, Centre Régional de Lutte Contre le Cancer Paul Papin, Angers; Jean-Christophe Pouget and Frédérique Baton, Ipsen Innovation, Les Ulis, France; Mihai Harza, Fundeni Clinical Institute, Bucharest, Romania; Anastasios Thanos, Agios Savas Anticancer Oncology Hospital of Athens, Athens, Greece; Patrick Werbrouck, Algemeen Ziekenhuis Groeninge, Kortrijk, Belgium; Martin Bögemann, Universitätsklinikum Münster, Münster, Germany; Thomas Hutson, Texas Oncology, Dallas, TX; Piotr Milecki, Poznan University of Medical Sciences, Poznan, Poland; Enrique Gallardo, Corporació Sanitaria Parc Taulí, Sabadell, Spain; Gilberto Schwartsmann, Hospital De Clinicas De Porto Alegre, Porto Alegre, Brazil; Thore Nederman and Helen Tuvesson, Active Biotech, Lund, Sweden; and Michael Carducci, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD.
Purpose:
Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit.
Patients And Methods:
Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point.
Results:
In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain.
Conclusion:
In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed.
Insights
Tasquinimod improved progression-free survival in men with metastatic castration-resistant prostate cancer. However, this oral therapy did not demonstrate an overall survival benefit in the phase III trial.
Area of Science:
- Oncology
- Clinical Trials
- Prostate Cancer Research
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) remains a significant clinical challenge.
- Tasquinimod targets the tumor microenvironment, offering a novel therapeutic approach.
- Previous phase II trials suggested potential benefits in progression-free survival (PFS).
Purpose of the Study:
- To confirm the efficacy of tasquinimod in improving PFS in men with mCRPC.
- To evaluate the potential for an overall survival (OS) benefit with tasquinimod treatment.
- To assess the safety and tolerability of tasquinimod in this patient population.
Main Methods:
- A randomized, placebo-controlled phase III trial involving 1,245 chemotherapy-naïve men with mCRPC and bone metastases.
- Patients were assigned 2:1 to receive daily oral tasquinimod or placebo.
- The primary endpoint was radiographic progression-free survival (rPFS), with OS as a key secondary endpoint.
Main Results:
- Tasquinimod significantly improved median rPFS from 4.4 months with placebo to 7.0 months (HR, 0.64; P < .001).
- No significant difference in median OS was observed between the tasquinimod and placebo groups (21.3 vs 24.0 months; HR, 1.10; P = .25).
- Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8%) compared to placebo (33.6%), including anemia, fatigue, and cancer pain.
Conclusions:
- Tasquinimod demonstrated a significant improvement in radiographic progression-free survival in chemotherapy-naïve men with mCRPC.
- The study did not confirm an overall survival benefit for tasquinimod in this patient population.
- Adverse events were more common with tasquinimod, highlighting the need for careful patient monitoring.
