Sutent disappoints in lung cancer
pharmafile | August 24, 2010 | News story | Research and Development, Sales and Marketing | NSCLC, Pfizer, Sutent, Tarceva
Pfizer’s Sutent has failed to improve overall survival in lung cancer patients when combined with Roche’s Tarceva.
Pfizer’s SUN 1087 phase III trial combined Sutent (sunitinib) and Tarceva (erlotinib) and tested against Tarceva as a monotherapy in patients with previously treated non-small cell lung cancer (NSCLC).
The primary endpoint of increasing overall survival was not met, but progression-free survival, the secondary endpoint, showed a “statistically significant improvement”.
Dr. Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer’s oncology business unit, said: “While this trial did not demonstrate a statistically significant improvement in overall survival for patients treated with sunitinib plus erlotinib, we believe that the statistically significant improvement in progression free survival is an important finding.
“Over the next few months, we will conduct an in-depth analysis to gain further insight into these results and determine whether we can identify one or more subgroups of non-small cell lung cancer patients for a future trial in either previously untreated or recurrent disease.”
Roche’s blockbuster oncology drug Avastin plus chemotherapy agents remains as the standard drug treatment for advanced NSCLC. This is not the case in the UK, as the drugs watchdog NICE terminated its appraisal for NSCLC indication in 2007 after Roche failed to provide cost-effectiveness data.
It remains a difficult disease area to treat with a number of late-stage trials failing in recent months.
Sutent targets the vascular endothelial growth factor receptor (VEGFR) and the platelet-derived growth factor receptor (PDGFR). Both of these factors are expressed by a number of solid tumour types and are thought to play a crucial role in angiogenesis, the process by which tumours acquire blood vessels, oxygen and nutrients needed for growth.
The drug is currently in late-stage trials for castration-resistant prostate cancer and as a post-surgery therapy for renal cell carcinoma. The drug failed to meet its primary endpoints for a new HER-2 negative breast cancer indication in March.
Pfizer is also developing two other lung cancer candidates, with its crizotinib ALK inhibitor currently undergoing successful phase III trials and PF-299804, an irreversible, oral, selective pan-human epidermal growth factor receptor (HER) inhibitor currently in late-stage trials.
Pfizer says it will continue to analyse the lung cancer data and will submit the results to the European Society for Medical Oncology Congress in Milan this October.
Ben Adams
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