Roche's Avastin fails to show overall survival

Roche's Avastin (bevacizumab) failed to show an overall survival benefit in a European lung cancer trial. The Swiss drug major's $4.1 billion-a-year drug, which is also approved for colon, breast and kidney cancer, did however increase progression-free survival, the endpoint on which the agent was approved in this indication last year (Marketletter September 3, 2007).

Analysts at Lehman Brothers noted that the discrepancy is due to the confounding factors of second-line therapy. In light of the results, they made no changes to their sales forecasts for the drug, which assume just 10% penetration for ex-US lung cancer patients and a $500.0 million peak annual sales from this indication. Goldman Sachs analyst May-Kin Ho wrote in a note to investors that the findings could prompt negative sentiment towards Avastin. The drug is the top earner for Roche's wholly-owned subsidiary Genentech, whose first-quarter 2008 results disappointed investors because of lackluster revenue from the agent (Marketletter April 21).

The Phase III AVAiL study, which tested Avastin in combination with gemcitabine and cisplatin chemotherapy in patients with advanced, non-squamous, non-small cell lung cancer confirmed a previously-observed clinically and statistically-significant improvement in the primary endpoint of PFS for the two different doses studied, 15mg/kg and 7.5mg/kg, compared to chemotherapy alone.