AstraZeneca Imfinzi Data: Winning By Going Its Own Way
(Bloomberg Gadfly) -- In the multi-billion-dollar market for a new group of medicines that unleash the human immune system on cancers, AstraZeneca PLC has been an afterthought.
Lagging in the race to gain market share in immuno-oncology (IO) drugs, Astra made a big bet on a combination of two IO medicines to treat lung cancer. The combo has been a flop so far. But Astra pulled an ace out of its sleeve on Saturday, presenting successful trial data at a European cancer conference for its lead IO drug Imfinzi in a segment of the lung market rivals haven't really touched.
But celebrating isn't enough. Astra's rapid turn from failure to success needs to inform its IO approach going forward.
The market for cancer drugs is complicated. The FDA can limit or grant patient access based on disease severity, other medicines a patient has tried, particular genetic mutations, or several such criteria at once. Amid this complexity, there are plenty of niches where a smart company can find success.
Astra found one in lung cancer. While rivals have focused on later-stage lung-cancer patients, Astra's Imfinzi trial looked at patients with mid-stage disease. That may not be the mega-blockbuster market represented by newly diagnosed late-stage patients -- the market Astra has chased with its combo approach, and which competitor Merck & Co. dominates.
But a successful trial in this niche gives Astra a shot at a near-term FDA approval for Imfinzi in these patients and a market segment to itself. Analyst estimates for $1 billion in Imfinzi sales by 2019 looked shaky after the initial failure of Astra's combo trial. It simply wasn't going to happen in the one market for which the drug is currently approved, the crowded bladder-cancer market. But now there's a real chance of substantial sales growth.
Still, leads don't last long in this class of drugs. Other IO leaders are testing their medicines in this patient group, though their efforts are in earlier stages. Astra will have to replicate this success if it wants to expand Imfinzi's potential.
To do so, Astra needs to learn from the failure of its combo approach, where it chased a strategy in which Bristol-Myers Squibb & Co. had already heavily invested. It must also learn from the success of targeting an open segment of the market well ahead of competitors. There's a troubling tendency in this market for companies to ape each other and run the same types of studies in the same cancers, afraid of ceding markets to their competitors.
Trekking alone into the clinical-trial unknown can feel riskier. But the rewards are far higher.
This column does not necessarily reflect the opinion of Bloomberg LP and its owners.
Max Nisen is a Bloomberg Gadfly columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.