Alimta was already approved for first- and second-line treatment of lung cancer as well as for mesothelioma. It generated sales of $1.15 billion in 2008, and the lung cancer maintenance indication could boost that significantly.
The trick will be tapping the maintenance market. Lung cancer doctors tend to treat their patients with a first-line therapy like chemo or Genentech's Avastin (bevacizumab) and then wait for the tumor to progress before starting a second-line therapy like a different chemo or OSI Pharmaceuticals and Genentech's Tarceva (erlotinib).
The idea behind maintenance therapy is to keep right on treating after first-line therapy with the hope of delaying or preventing progression. When Lilly followed platinum-based induction chemo with maintenance Alimta, it saw increased survival.
The problem with maintenance therapy, physician Renato Martins of the Fred Hutchinson Cancer Research Center said in a previous BioWorld interview, is that it means treating patients who otherwise might be enjoying a drug holiday. And doctors don't really like doing that.
But that's not stopping drug companies from pursuing the lung cancer maintenance market. And Alimta better get docs on board fast because its first-mover advantage may be short lived.
Tarceva is already under FDA review for maintenance. A Phase III trial known as SATURN showed that Tarceva monotherapy improved progression-free survival over placebo in the maintenance setting. And earlier this year, the Phase III ATLAS study was stopped early when the combination of Avastin and Tarceva beat Avastin alone for maintenance.
Tarceva has two potential advantages over Alimta. One: a fair amount of patients use Avastin for first-line treatment already, and tacking on Tarceva could be an easier sell to docs than the idea of a stand-alone maintenance therapy. Two: Alimta can only be used in nonsquamous patients, while Tarceva is under no such restrictions.
But the Avastin-Tarceva combo is not a home run: it failed a Phase III trial in second-line lung cancer treatment, which may make some docs skeptical.
Lung ashtray photo by Flickr user bbaunach, CC2.0