AstraZeneca lung cancer immunotherapy trial failure sends shares plunging

highly anticipated clinical trial combining two immunotherapy drugs failed to delay tumor growth in patients with newly diagnosed lung cancer, sending AstraZeneca sharply lower Thursday.
The negative results from the so-called MYSTIC study are a stinging setback to AstraZeneca’s ambition to leapfrog over its cancer immunotherapy rivals.
Three years ago, AstraZeneca CEO Pascal Soriot rebuffed a $117 billion takeover offer from Pfizer, insisting the Anglo-Swedish drug maker’s pipeline would succeed on its own. On Thursday, AstraZeneca shares plunged 16 percent to $28.60 on investor fears that Soriot’s promise is coming up empty.
In the preliminary MYSTIC clinical trial results, the combination of checkpoint inhibitor Imfinzi and the CTLA-4 inhibitor tremelimumab failed to slow disease progression compared to chemotherapy. The patients enrolled in the study were newly diagnosed with non-small cell lung cancer that expressed a protein known as PD-L1 on 25 percent or more of the tumor cells.
Tumors with higher levels of PD-L1 are believed to be more vulnerable to cancer immunotherapies, which is why the protein is often used as an enrollment biomarker in clinical trials.
Also reported from the MYSTIC study, the use of Imfinzi alone in a different group of newly diagnosed lung cancer patients would not have shown a difference in tumor progression compared with chemotherapy, the company said.
AstraZeneca will continue to follow patients in the MYSTIC study, hoping that the combination of Imfinzi and tremelimumab might help patients live longer than chemotherapy alone. Those overall survival results are expected in the first half of next year.
Imfinzi is approved for bladder cancer but the lung cancer trial failure all but guarantees that projections of peak sales of $7 billion will never be met.
Merck is an immediate beneficiary of AstraZeneca’s misfortune because its checkpoint inhibitor Keytruda in combination with chemotherapy is already approved to treat newly diagnosed lung cancer patients. Merck shares were up 3.5 percent to $64 in early trading.
Shares of Bristol-Myers Squibb fell 6 percent to $52.50 early Thursday on concerns that a large clinical trial combining its two immunotherapy drugs Opdivo and Yervoy in lung cancer could meet the same fate as AstraZeneca’s.
In a related announcement Thursday, AstraZeneca and Merck signed a deal to develop and market the PARP inhibitor Lynparza for different types of cancer. Merck is paying AstraZeneca $1.6 billion upfront to gain rights to Lynparza, which it plans to study in combination with Keytruda and other drugs. If all conditions of the partnership are met, Merck will pay AstraZeneca as much as $8.5 billion.


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