AstraZeneca presented updated results from a phase I study of AZD9291 at a European cancer conference this weekend, including new disclosure of an estimated median progression-free survival (PFS) of 9.6 months in patients with non-small cell lung cancer expressing the T790 mutation.
The '9291 PFS data are still immature and may improve with subsequent updates from the study, but investors jumped on the results as a signal Clovis' rival drug rociletinib might be more effective. The estimated, but also immature, PFS benefit for rociletinib is more than 12 months, according to data presented last June. Clovis is expected to release updated results from its rociletinib lung cancer study in November. That update will give investors a better side-by-side comparison between the two competing lung cancer drugs but for Monday at least, the sentiment shifted a bit to favor Clovis over AstraZeneca.
Clovis shares are up 16% to $49.16 in Monday midday trading.
Both Clovis' rociletinib (formerly known as CO-1686) and AstraZeneca's '9291 are designed to be effective against non-small cell lung cancer containing a genetic mutation known as T790M, which renders tumors resistant to treatment with drugs like Roche's (RHHBY) Tarceva. Both companies are conducting phase III studies of their respective drugs right now, so the race is on to compile data and submit to U.S. and European regulators as quickly as possible. Rociletinib and '9291 are not being tested head to head, so lung cancer doctors have been reluctant to anoint one drug superior over the other, despite efforts by Clovis and AstraZeneca to make those claims.
This weekend, AstraZeneca said '9291 will likely be submitted for approval in the second half of next year -- guidance that disappointed some investors who were expecting a more aggressive timetable. Clovis' guidance has been for a rociletinib approval submission "midyear" 2015.