Cervical Cancer: commercial opportunities likely to remain despite preventative potential

With promising interim results for vaccines that work against the human papillomavirus, the major cause of cervical cancer, prevention of this disease has become a real possibility. Western society however, may not be ready for a cure that requires twelve and thirteen year-old girls to be immunized against a venereal disease, leaving commercial opportunity in an area of high unmet need.

The majority (98%) of all cervical cancers are the result of HPV (human papillomavirus) infection. The virus initially causes a low-grade hyperplasia, which is easily treated, but which can remain for up to 15 years before progressing to invasive disease. Consequently, there is a large window of opportunity for early diagnosis and treatment through screening, and so most Western countries have initiated public health programs for cervical cancer, with the result that mortality has been cut by 80% in some countries.

But now the prevention of cervical cancer is becoming a real possibility, as HPV vaccines are producing promising interim trial results. In the Market Brief Cervical Cancer: Is society ready for a preventative answer? Datamonitor provides an overview of the current cervical cancer market as well as some of the particular challenges pharma companies will face over the next five years as the first HPV vaccines become available.

Mass vaccination

With the implementation of effective screening programs over the past three decades, especially in the West, both the mortality and size of the drug treated population in cervical cancer have been reduced by up to 80%. However, for the small percentage who fall through the screening net and go on to develop metastatic disease, drug therapy remains largely ineffective.

As the HPV vaccines begin to come to market over the next five years or so, it will be possible to implement for the first time a mass preventative vaccination program in cervical cancer.

However, the greatest barrier to the uptake of such a vaccine is likely to be a lack of social acceptance for immunizing young girls of 12 or 13, the ideal vaccination population, against a venereal disease. This will be especially difficult in the more conservative Western markets such as the US, where traditional views on birth control, abortion, and child health issues still largely prevail.

In such an atmosphere, it will be difficult for Merck & Co, the company with the marketing rights to the most advanced HPV vaccine, to drive the uptake of its drug in the US. Merck may well be forced to target other territories, such as the more liberal European markets of France and the UK, to maximize the performance of its vaccine.

Evidence required

Pharmaceutical companies will have more success if they target developing countries for mass vaccination programs where the incidence of cervical cancer through HPV infection is far greater than in the West. Working in collaboration with governments in developing countries could lead to greater opportunities elsewhere.

Successful programs in these areas will enable Merck and the other manufacturers of HPV vaccines, to prove the benefits of mass vaccination. Only when such evidence is provided will the conservative governments in the West be willing to implement such programs.

For those companies with vaccines in the early stages of development, the challenge will be to develop products which are effective against women already infected with HPV. Effective vaccines in this area would eliminate the problem of having to immunize school children. If these second-to-market vaccines achieve this goal, then their uptake and usage will quickly surpass that of Merck’s prophylactic vaccine.

Room for other treatments

The treatment of locally advanced cervical cancer has already been drastically changed recently after data showed the impact of combined radiotherapy and chemotherapy treatment.

A total of five randomized phase III trials have shown an overall survival advantage for cisplatin plus radiotherapy in locally advanced cervical cancer.

These studies point to a significant reduction in the risk of death, of the order of 30-50%, while five-year survival rates are around 60-70%. Now, most patients with locally advanced disease can expect to receive concurrent cisplatin-based chemotherapy and radiation therapy following surgery.

With vaccines unlikely to have an impact upon the biggest drug market of the US for some time, an opportunity therefore awaits pharmaceutical companies with drugs capable of working in combination with cisplatin as concomitant chemotherapy. With such vaccines on the horizon however, the return on investment issue will remain prevalent for companies looking to gain reward in this market.

This financial risk could be reduced by running trials in collaboration with respected research organizations and centers, such as Memorial Sloan Kettering and MD Anderson, in phase I and II, then moving to larger organizations such as the Gynecologic Oncology Group with solid phase II data when seeking phase III trials. With endorsement from such organizations, many physicians will alter their prescribing practice, even if no SNDA (supplementary new drug application) has been submitted.

Unmet need

Metastatic cervical cancer remains one of the most underserved oncology indications. Although the impact of cervical cancer screening has reduced the patient potential for this indication, and the potential of HPV vaccines promises to reduce the value of the indication still further, the problems preventing these vaccines from making an immediate impact has left commercial opportunities not available in other oncology indications.

With Western states, and the US in particular, unlikely to adopt the use of widespread use HPV vaccines in the near future, many metastatic cervical cancer patients will require treatment for decades to come.

Significantly, the cervical cancer market represents an overall R&D opportunity for the leading drug makers. Cervical cancer development more often than not yields drugs which are active against a wide range of tumor types. This indication could therefore provide companies with developmental agents likely to have activity in a wide range of tumors with an easy route to market approval and a springboard to usage in more lucrative indications.

If you found this week's Expert View useful, you may be interested in Datamonitor's reports:

• Cervical Cancer: Is Society Ready For a Preventative Answer? priced $1,600
• Stakeholder Opinions: Ovarian Cancer - Beyond Carboplatin and Paclitaxel priced $3,200
• Human Papilloma Virus - An Oncogenic Pathogen priced $1,500

To order these reports - click here! - then search by title or contact sales@bioportfolio.com