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The US Preventive Services Task Force has announced new recommendations against routine testing of middle-aged men for prostate cancer. Meanwhile, enzalutamide has been filed with US authorities and Active Biotech has reached the midway point in recruiting patients for a Phase III trial of tasquinimod.
IHS Global Insight Perspective
The US Preventive Services Task Force recommendation against the routine testing of middle-aged men for prostate cancer overturns over two decades of standard practice under which the prostate-specific antigen test is generally given to middle-aged men, even if they are healthy. The Task Force has concluded that the myriad of risks associated with false positives outweighs the benefits of capturing more patients.
At the same time, two investigational agents in prostate cancer are making strong progress towards potential market access, with Medivation and Astellas's enzalutamide being filed with US regulators in castration-resistant prostate cancer, and Active Biotech receiving a EUR10-million milestone payment from licensing partner Ipsen for progress in its pivotal Phase III trial for tasquinimod in a similar setting.
Prostate cancer has already seen several new therapies reach the market in the last year or so, but most have struggled to achieve immediate, favourable reimbursement settings as companies struggle to match the cost of the treatment with the response rates and outcomes. By 2013–14, there may be two more agents making their mark on the market here as the prostate cancer area evolves through patient segmentation and clinical differentiation from new interventions.
PSA Test Non-Recommendation
The US Preventive Services Task Force has announced new recommendations against routine testing of middle-aged men for prostate cancer. The Task Force noted that "there is a very small potential benefit and significant potential harms. We encourage clinicians to consider this evidence and not screen their patients with a prostate-specific antigen (PSA) test unless the individual being screened understands what is known about PSA screening and makes the personal decision that even a small possibility of benefit outweighs the known risk of harms." The recommendations are available here.
It concluded that routine testing saves around 1 person in every 1,000, but that this is a small benefit compared to the significant caseload of patients who are given "unnecessary" surgery, radiation and chemotherapy due to the diagnostic variability of the PSA test. Similar questions have been raised in Europe, and the announcement represents a small, incremental negative for the drug industry, which relies on extensive screening and testing to ensure patients are adequately diagnosed. Still, it is unlikely to have much of an immediate impact, as it will take some time before such a deeply ingrained part of medical practice is amended, but over time it is likely that insurers will begin to only focus on higher-risk patients or patients with symptoms.
New Therapies on Horizon
Separately, United States drug firm Medivation and its partner Astellas Pharma (Japan) have announced the submission of a New Drug Application with the US FDA for MDV-3100 (enzalutamide). The companies are seeking approval in patients with castration-resistant prostate cancer who have received docetaxel therapy. Medivation has sought a priority review for the oral, once-daily androgen receptor-signalling inhibitor. The submission is based on the Phase III AFFIRM trial.
Also in the castration-resistant prostate cancer market, Active Biotech (Sweden) has announced a EUR10-million (USD12.64 million) milestone payment from its licensing partner Ipsen (France), after the company reached a midway point in the recruitment of the pivotal Phase III trial for tasquinimod. The 1,200-patient trial is aiming to show progression-free survival (PFS) of tasquinimod 0.25mg, 0.5mg or 1mg per day against placebo.
Outlook and Implications
Prostate cancer has already seen several new therapies reach the market in the last year or so, including US firm Dendreon's infamous Provenge (sipuleucel-T), French firm Sanofi's Jevtana (cabazitaxel), and US pharma Johnson & Johnson's Zytiga (abiraterone). Most of these therapies struggled to achieve immediate, favourable reimbursement settings, however, as companies struggle to match the cost of treatment with the response rates and outcomes. By 2013–14, there may be two more agents making their mark on this market as the prostate cancer area evolves through patient segmentation and clinical differentiation from new interventions. Tasquinimod's key differentiator remains that it is not a hormonal therapy, but rather a pleotropic treatment with immunomodulatory and anti-angiogenic properties. Active Biotech is aiming to achieve top-line data from the pivotal Phase III study by the end of 2014, with a regulatory filing expected the following year.