Sanofi’s Zaltrap data published
pharmafile | October 8, 2012 | News story | Research and Development, Sales and Marketing | Erbitux, Sanofi, Stivarga, Zaltrap, avastin
Detailed data from the Phase III trial of Sanofi’s newly-licenced anti-VEGF cancer drug Zaltrap, co-marketed with Regeneron, has been published.
Results of the VELOUR study in previously treated metastatic colorectal cancer (mCRC) appear in this month’s Journal of Clinical Oncology.
Zaltrap (ziv-aflibercept) was approved in August by the FDA following a priority review, and can be used in combination with 5-fluorouracil, leucovorin, irinotecan (Folfiri) for patients whose mCRC is resistant to or has progressed following an oxaliplatin-containing regimen.
VELOUR showed in this patient group that adding Zaltrap to Folfiri improved median survival from 12.06 months to 13.5 months.
Progression-free survival also improved, from 4.67 months to 6.9 months, while the overall response rate in the Zaltrap plus Folfiri arm was 19.8% versus 11.1% for Folfiri.
Common adverse reactions in the Zaltrap-Folfiri arm included neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria and asthenia.
The drug is under review at the European Medicines Agency and other regulators worldwide – but it looks likely that it will not add to its mCRC indication: it has already failed in studies for prostate, lung and pancreatic cancer.
Colorectal cancer is the third most commonly-diagnosed cancer in men and the second in women, with more than 1.2 million new cases and 600,000 deaths globally in 2008 alone.
The prevalence of the disease means Zaltrap has a lot of competition, including Roche’s Avastin, Bayer’s Stivarga, Bristol-Myers Squibb/Merck Serono’s Erbitux and Amgen’s Vectibix, all of which are well-established in mCRC.
Industry analysts have suggested they expect Zaltrap to have peak annual sales of around $300 million to $400 million – some way below Avastin and Erbitux.
The fact that Zaltrap has come late to the market and may not receive other licences are the main reasons why analysts do not see it as a huge seller – although Sanofi will need its revenue to help replace that lost by its anticoagulant Plavix’s generic erosion.
Adam Hill
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …
Sanofi completes acquisition of Vigil Neuroscience to early neurology pipeline
Sanofi has announced that it has finalised its acquisition of Vigil Neuroscience, a US-based biotechnology …
