Phase III data from a study of Sanofi's colorectal cancer drug Zaltrap have been published in the Journal of Clinical Oncology, reinforcing the recently-approved drug's prospects.
The results of the VELOUR study demonstrated that Zaltrap (ziv-aflibercept) given in combination with the widely-used FOLFIRI chemotherapy regimen showed a significant improvement in overall survival, progression-free survival (PFS), and the overall tumour response rate versus placebo.
In patients whose cancer had already progressed despite prior treatment with oxaliplatin-based chemotherapy, adding Zaltrap to FOLFIRI (5-fluorouracil, leucovorin, irinotecan) significantly improved median survival from 12.06 months to 13.50 months, an 18 per cent reduction.
Similarly, PFS improved from 4.67 months to 6.90 months, which was equivalent to a 24 per cent risk reduction, according to the study.
Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumours and was approved in the US in August. It is also under review in the EU, where the European Medicines Agency (EMA) is due to deliver a verdict on the application by the end of the year.
Analysts have predicted modest sales as a second-line therapy for colorectal cancer – in the region of $200m to $300m a year – but with the potential for significant upside if Zaltrap also proves its worth as a first-line treatment and in other cancers.
The drug has faltered during trials in lung and prostate cancers, however, with mixed results in ovarian cancer, so Sanofi and partner Regeneron may struggle to expand its use significantly.
Regardless of Zaltrap's ultimate sales potential, approval of the new drug was an important milestone for Sanofi after it set up a dedicated oncology research division in 2008.
Despite some late-stage failures - including breast cancer candidate iniparib - the company now has more cancer new molecular entities (NMEs) in its pipeline than any other category, accounting for 15 of its 47 clinical projects.