Drug Development

Now a two-time loser, AstraZeneca’s hopes for selumetinib dwindle after another PhIII flop

AstraZeneca’s one-time blockbuster hopeful selumetinib is now a two-time loser in late-stage development. The pharma giant was forced to concede Tuesday morning that the drug flopped in KRAS-positive non-small cell lung cancer. The drug whiffed on progression-free survival and failed to score on overall survival as well.

AstraZeneca had to walk away from the first Phase III for selumetinib last year after the drug — in-licensed from Array — failed for an eye cancer called uveal melanoma.

The back-to-back failures leave shrinking hope that the drug can ever live up to the blockbuster future that CEO Pascal Soriot had forecast for it several years ago. The drug was a significant piece of AstraZeneca’s promise to build revenues to $45 billion by 2023. Now it’s another example of the hit-and-miss fortunes of the pharma giant since Soriot took the helm.

AstraZeneca’s plans for the drug have dwindled down to thyroid cancer, where it won’t be given good odds of success. AstraZeneca is known for staying rigidly focused on adding important drugs to its portfolio, a strategy that has led to the discount sales of troubled drugs like brodalumab and lesinurad.

Shares of AstraZeneca slipped a little Tuesday morning, while shares of Array $ARRY cratered, dropping 18% in pre-market trading.

As selumetinib and other drugs faded, AstraZeneca’s success with Tagrisso loomed large as an example of what the cancer drug side of the company could accomplish. Those hopes extend to the PD-L1 drug durvalumab, now in a big Phase III program as Bristol-Myers, Merck and Roche all divvy up the market with approved drugs. But AstraZeneca has had other setbacks on the cancer front as well. Last spring, just weeks after AstraZeneca ($AZN) reported a success for a combination study of durvalumab and tremelimumab, the pharma giant was forced to concede that the CTLA-4 drug tremelimumab flunked a solo challenge for mesothelioma.

Sean Bohen

Sean Bohen, AstraZeneca CMO

AstraZeneca CMO Sean Bohen was left to read the last rites over the lung cancer study. And he didn’t sound hopeful that this drug had much of a future in a prepared statement:

A randomized Phase II trial showed promising activity of selumetinib in combination with docetaxel in patients with KRASmutation-positive lung cancer. It is disappointing for patients that these results have not been confirmed in Phase III. We expect to present data at a forthcoming medical meeting. We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments.


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