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Tasquinimod May Improve Survival in Men With Metastatic Prostate Cancer

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Key Points

  • Patients with metastatic castration-resistant prostate cancer and bone metastases remained progression-free for an average of 8.8 months on tasquinimod, compared with 3.4 months on placebo.
  • Patients with bone metastases who received tasquinimod had a median overall survival of 34.2 months, compared with 27.1 months for placebo.
  • Tasquinimod was considered safe, with low to moderate side effects.

An investigational prostate cancer treatment slows the disease’s progression and may increase survival, especially among men whose cancer has spread to the bones, according an analysis led by the Duke Cancer Institute. The study, published in the journal Clinical Cancer Research, adds long-term survival and safety data for the drug tasquinimod, a new candidate for treating advanced and recurrent prostate cancer.

“While all subgroups in the clinical trial benefited from tasquinimod, those whose cancer metastasized to their bones had the greatest benefit in terms of delaying the time from the start of treatment to when the cancer progressed,” said lead author Andrew J. Armstrong, MD, ScM, Associate Professor of Medicine at the Duke Cancer Institute. “This group of men also seemed to have a longer survival benefit when we followed them over several years.”

Tasquinimod is an oral therapy that activates the body’s immune system to fight cancer and is known to block angiogenesis. Its mechanism is not fully understood, but it appears to affect the function of myeloid-derived suppressor cells, which are found in increased numbers in cancer patients.

New treatments approved in recent years have given physicians and patients additional options to fight prostate cancer, but the therapies typically only extend patients’ lives by 3 to 5 months. New drugs that increase survival without producing serious side effects are still needed.

Phase II Study

In this phase II clinical trial, researchers studied the use of tasquinimod among men with metastatic castration-resistant prostate cancer. The study enrolled 201 men who were followed for approximately 3 years, with 134 randomly assigned to receive tasquinimod and 67 given placebo. The researchers measured patients’ overall survival, progression-free survival, and the drug’s safety and tolerability. They also conducted studies of biomarkers to better understand how tasquinimod stimulates the immune system.

Dr. Armstrong and his colleagues found that men taking tasquinimod saw no cancer progression for an average of 7.6 months, compared with 3.3 months for placebo. Men whose cancer had already metastasized to their bones and took tasquinimod remained progression-free for even longer—8.8 months, compared with 3.4 months for placebo.

“By delaying the onset of symptoms or growth of metastatic tumors, tasquinimod may allow men to put off other treatments, such as chemotherapy, and maintain a high quality of life,” Dr. Armstrong said. “That’s an important goal for many patients and providers.”

Median overall survival for men receiving tasquinimod was 33.4 months, compared with 30.4 months for those taking placebo. However, patients whose cancer had already metastasized to their bones survived an average of 34.2 months, compared with 27.1 months for placebo, a 7-month difference. This improvement in survival with tasquinimod persisted when statistical adjustments were made for other prognostic factors such as prostate-specific antigen (PSA) level, PSA doubling time, lactate dehydrogenase levels, and the presence of anemia.

The researchers also identified certain predictors of who would benefit most from tasquinimod, such as lower baseline PSA levels or other biomarkers.

Tasquinimod was considered safe, with low to moderate side effects, which included mild gastrointestinal issues, muscle and joint pains, and fatigue.

Phase III Study Underway

Based on results from the phase II clinical trial, tasquinimod is now being evaluated in an international phase III trial focusing on men whose prostate cancer has spread to their bones and become resistant to hormonal therapies.

“We still need to do more research to understand the efficacy and mechanism of action of tasquinimod, who benefits the most from it, how it fits into a treatment regimen, and how it could be used in combination with other therapies,” Dr. Armstrong said. “In addition, tasquinimod is not a prostate cancer–specific drug. If the phase III trial shows that tasquinimod is effective and safe, this opens the door for evaluating the immunotherapy in other cancers.”

This study was funded by Active Biotech, a codeveloper of tasquinimod. The research was conducted within the Department of Defense Prostate Cancer Clinical Trials Consortium.

Dr. Armstrong and study author Roberto Pilli, MD, received research funding from Active Biotech. Study authors Örjan Nordle and Göran Forsberg, PhD, are employees and shareholders of Active Biotech.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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