Anyone harboring any last shred of hope in seeing AstraZeneca ($AZN) gain an accelerated approval on its marquee drug program for durvalumab should be prepared to be disappointed. The pharma giant says its latest read on a single-arm study of durvalumab, a PD-L1 checkpoint inhibitor, indicates that investigators won't come out with the data needed to win over regulators--virtually ruling out any move to gain a fast approval to use it as a solo therapy to fight lung cancer as the leaders in the field continue to consolidate their positions.
"As previously communicated, the treatment and regulatory landscape in lung cancer is evolving," said Sean Bohen, the chief medical officer at AstraZeneca, in a statement. "We now believe it is unlikely that ATLANTIC can be used for regulatory submission as a monotherapy, but we will make that determination following a full analysis of the data. Durvalumab is a cornerstone of our immuno-oncology portfolio with a fast advancing development program focused primarily on novel combinations."
Bohen also tried to reassure analysts, noting that investigators were still tracking clinical activity for the drug in the study. But AstraZeneca needed a home run here, and it's claiming a bunt. Getting to home base now--at least in lung cancer--will evidently depend significantly on its success with combos.
AstraZeneca has positioned durvalumab as its star development effort, pointing to its potential to follow up on game-changing approvals for Merck ($MRK) and Bristol-Myers Squibb ($BMY).
|AstraZeneca CEO Pascal Soriot|
AstraZeneca and Roche ($RHHBY) have been seen as the two top contenders to follow up on the success of Keytruda and Opdivo. But while Roche has been making fast progress in a wide-ranging late-stage program for atezolizumab, looking for a Q1 2016 filing, AstraZeneca CEO Pascal Soriot has had to caution analysts recently to expect delays in its program, saying that regulators are less likely to feel an urgent need to approve new checkpoint drugs now that the first are on the market.
This latest remark is another red flag for analysts, many of whom had been cheered by the recent approval of Tagrisso (AZD9291). Durvalumab has been repeatedly held up as a top program with the capacity to produce billions in new revenue, badly needed to replace revenue being lost to generic competitors.
The company's issues with durvalumab may also help explain why AstraZeneca pushed ahead with a rich, $7 billion deal to buy Acerta, and may indicate that more new deals lie ahead. AstraZeneca projected peak sales of $6.5 billion for durvalumab when it laid out a plan to boost revenue to $45 billion in 2023. If that drug falls off the fast track, the Big Pharma will need more shots on late-stage goals.
Checkpoint inhibitors are designed to break a key mechanism that cancer cells use to stay hidden from the immune system, unleashing a powerful attack against a wide range of cancers. Keytruda was recently credited with helping former president Jimmy Carter in his fight against cancer, a widely reported story that has helped fuel public demand for the treatment.
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