AstraZeneca’s Imfinzi already has an FDA approval in the lung cancer maintenance setting under its belt, something none of its rivals will be able to say for a while. And Friday, it hit another key benchmark to stretch out that lead.
Imfinzi topped placebo at extending overall survival among patients with unresectable, stage 3 non-small cell lung cancer who were in maintenance mode after receiving chemo and radiation, AstraZeneca said.
In doing so, it hit the second primary endpoint of the trial, dubbed Pacific—and it did so earlier than expected, Jefferies analyst Ian Hilliker pointed out in a note to clients. AstraZeneca had “previously indicated it was not anticipated until 2019.”
AstraZeneca became the first immuno-oncology drugmaker to grab an OK in lung cancer maintenance back in February after showing Imfinzi could keep disease at bay for a median 16.8 months—11.2 months longer than placebo could. Analysts predict the med could rake in more than $1 billion from that indication alone, especially considering rivals are years away from securing competing nods.
“Whilst we still have to see the details of the actual benefit achieved, having OS data on the label will further reinforce Imfinzi’s position as the leading I-O therapy in this setting, with any potential competitor data still some way off,” Hilliker wrote of the latest win.
AstraZeneca said Friday that it's ready to take the new stats to regulators. “We look forward to sharing these results with health authorities to support ongoing regulatory interactions and to update the Imfinzi label with these important data,” company R&D chief Sean Bohen said in a statement.
Having that market all to itself is important for AstraZeneca, which is counting on Imfinzi to help pull it out of what’s been a dark period for the patent-cliff-plagued pharma giant. Imfinzi shares its other current market—bladder cancer—with all four other approved PD-1/PD-L1 products, and if it can nab an approval in lung cancer—which is still up in the air—it’ll have to vie with some pretty big competitors. Keytruda-maker Merck, in particular, has seemed to run away with the market lead over the last few months, posting three big wins in the clinic to shore up its No. 1 position.