Pfizer has been boosted by news concerning its targeted cancer therapy Sutent (sunitinib malate). The orally-administered small molecule tyrosine kinase inhibitor is now recommended in new European Association of Urology guidelines, released during the Association’s annual meeting in Berlin last week, for first-line therapy of patients with metastatic renal cell cancer of “good and intermediate” risk.
The news follows EU marketing approval for first-line use in mRCC granted earlier this year, meanwhile, Sutent is already indicated for second-line treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST).
Highly significant survival data
The EAU recommendation is classified as 'grade A' on the strength of pivotal Phase III data showing that Sutent, compared with standard interferon alpha therapy, more than doubled progression-free survival (median 11 months versus five months). Sutent also achieved a five-fold higher objective response rate (31% vs 6%) and was better tolerated than IFN alpha. The results were highly statistically significant. Data on overall survival are not yet available, but urology expert Professor Jean-Jacques Patards of Rennes University Hospital, France said in Berlin last week there is a trend to improved median overall survival with Sutent compared to IFN alpha (Hazard Ratio 0.65)
Although the guidelines are primarily aimed at urologists rather than medical oncologists who manage mRCC in some European countries, Professor Joaquim Bellmunt of University Hospital del Mar, Barcelona, Spain, said management is increasingly becoming a multidisciplinary effort with treatment decisions taken after consultation among urologists, oncologists, radiologists and pathologists. However, use of Sutent depends on political decisions taken by government bodies regarding their willingness to fund therapy, he pointed out. “Guidelines are based on science, but science has a cost.” This cancer is not highly prevalent, so funding considerations may be more sympathetic than for other cancers affecting larger numbers, he suggested.
On the strength of its promise in mRCC, Sutent should be studied in combination with other agents and as adjuvant and neo-adjuvant therapy to prevent tumour recurrence following nephrectomy, said experts speaking in a Pfizer-sponsored symposium. Sutent remains well ahead of competition from other targeted therapies for the time being.
A trial comparing Bayer's Nexavar (sorafenib) and IFN alpha as first-line therapy is in progress. Meanwhile, Phase III data from a study involving bevacizumab (Avastin/Roche) plus IFN alpha versus IFN alpha alone are expected to be presented at this year’s American Society of Clinical Oncology meeting in June.