Melanoma - Lucrative commercial opportunities persist

Melanoma comprises just 5% of all skin cancers but it is the most deadly. In 2006, more than 100,000 cases of the disease are expected to be diagnosed in the seven major pharmaceutical markets. High unmet needs still persist for this tumor type and despite three decades of extensive R&D, five-year survival of advanced patients remains below 20%.

Although the late-stage melanoma pipeline is diverse, five of the nine agents have had a turbulent development history. As a result of these developmental problems, stakeholders hold a generally pessimistic view of a significant proportion of the late-stage pipeline candidates.

As Bayer/Onyx's Nexavar (sorafenib) failed to meet its Phase III primary endpoint of improving progression-free survival in relapsed advanced melanoma patients, Nexavar's future is now dependent on a second Phase III trial. As this trial involves chemotherapy-naive patients, Nexavar may have an increased chance of demonstrating improved survival.

Phase III clinical data is needed to distinguish between Pfizer's ticilimumab and Medarex/Bristol-Myers Squibb's ipilimumab. Given the presence of two Big Pharma players, the melanoma arena could become increasingly competitive, with each company vying for first-to-market status and product supremacy.

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