Parexel Discusses Prostate Cancer Treatment in Honor of Men's Health Month

Improving the Odds of Success in Prostate Cancer Therapy Development

BY Matthew Cooney, M.D., Senior Medical Director and Oncology Lead - 6.14.19

In recognition of Men’s Health Month, Parexel offers a deep dive into the challenges of developing therapies for prostate cancer.  Despite significant research advances, prostate cancer remains the second most frequently diagnosed cancer and the sixth most common cause of death from cancer among men worldwide.

Prostate cancer treatments have evolved over the 15 years since the release of docetaxel.  Treatment teams are now multi-disciplinary—in addition to just urologists, today medical and radiation oncologists, and a host of support personnel work to provide hope to patients.  An increasing number of diverse agents, including chemotherapy drugs, anti-androgens, radiopharmaceuticals, and immune therapies benefit patients. [See Fig. 1]

Despite these advances, the number of available treatment options for prostate cancer  patients pales in comparison to those for patients with breast or lung cancer, producing a substantial unmet need.

The potential for further prostate cancer research advances is exciting.  On the other hand, small to mid-size biotech companies looking to make an impact in this area face steep competition.  Developing a strong understanding of the environment—both approved products and those in the development pipeline—and the disease’s natural history are key prerequisites for success. 

Prostate.JPGFig. 1: After languishing for decades, the development of prostate cancer drugs accelerated rapidly in the last 15 years, resulting in an array of new products to treat late-stage disease.

Five ways to increase the probability of success in prostate cancer therapy development
1.      Don’t assume exciting science is enough

Recently, we met with a small biotech company hoping to expand into a prostate cancer indication.  Although they have outstanding science and an innovative product, their team lacked experience in prostate cancer.  They could stumble over any one of the common pitfalls, not understanding the stages of the disease, underestimating the competitiveness of the landscape, and not having a comprehensive development strategy. Past wins and stellar science are not enough to guarantee success.

2.      Explore indications that are under-addressed

Many pharma companies place their product in metastatic, castrate-resistant prostate cancer (mCRPC) in the 2nd line and beyond setting (after anti-androgen therapies have failed to stop the spread of cancer cells). There is intense competition to recruit patients for late-stage trials in these indications, while various other areas go unaddressed.  In April 2019, the clinicaltrials.gov website listed 171 active trials in advanced prostate cancer versus just four trials targeting early-stage disease.

3.      Be comfortable with your answers to these four questions
  • What is the regulatory landscape for prostate cancer compounds?
  • How do regional differences affect prostate cancer biology, treatment options, the standard of care, and anticipated response rates?
  • What were the development strategies for prior successful and unsuccessful products in prostate cancer?
  • Do we have the expertise for successful prostate cancer drug development?
4.      Think through how you will overcome the challenges
  • How will your product differentiate from current FDA-approved agents?
  • Which compounds in clinical development will likely achieve FDA approval and when? For example, darolutamide—under review by FDA as of April 2019—will be the third androgen receptor inhibitor to reach the market and will need to offer advantages over both Xtandi and Erleada to gain market share.
  • What resources will you need to design and conduct trials, tailor a regulatory strategy, and execute a global clinical development program?
  • Finally, what pricing and reimbursement constraints will your product face?
5.      Build a Multi-Disciplinary Development Team

In the global prostate cancer market, regulators and payers require that new products fill unmet needs and deliver cost-effective benefits. The surest path to meeting those demands is working with experts including clinical and regulatory affairs, trial logistics, and market access to work closely together. Each must be adequately represented on the team, usually by a mix of internal and external resources.

The prostate cancer development pipeline is crowded but there is still ample room for drugs that are developed with a smart strategy to make a positive impact on so many men facing this diagnosis.


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