AstraZeneca rushes immuno-oncology star into PhIII lung cancer study

Anxious to fight off Pfizer's ($PFE) $106 billion marriage proposal, AstraZeneca's ($AZN) research team has rushed its high-profile immuno-oncology drug into a late-stage test. And they're setting out by targeting non-small cell lung cancer in the first Phase III in the MEDI4736 program.

MEDI4736 is an anti-PD-L1 therapy, one of several immuno-oncology drugs now in late-stage testing after initial studies found that they could disable a tumor's built-in ability to evade the human immune system, demonstrating some impressive efficacy results for cancer patients. AstraZeneca has used this program as exhibit A in the shaky case that the company has pieced together an industry-leading pipeline that will deliver tens of billions of dollars in future revenue.  

AstraZeneca is jumping from Phase I straight into Phase III, like its rivals in the field, planning to recruit 702 patients for the randomized study. The company said earlier this week that the drug could earn $6.5 billion in peak annual sales.

PD-L1 is a complementary pathway to PD-1, which Merck ($MRK) and Bristol-Myers ($BMY) are going after in one of the highest profile showdowns in the industry. Roche ($RHHBY) also has a PD-L1 treatment which it is advancing as well, and you can expect to hear plenty more about all of them at the upcoming meeting of ASCO.

Merck said earlier this week that its PD-1 program for MK-3475, the leader in the development race, could be considered a pipeline in its own right. At this stage AstraZeneca benefits just by being in the Phase III running, though it's broadly seen as coming up behind the three Big Pharmas out front.  

"MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase III clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline," says AstraZeneca R&D exec Briggs Morrison, one of the leaders in the campaign against Pfizer. "Lung cancer is still the leading cancer killer; there is a clear need for more treatment options to provide patients with a better chance of beating the disease. We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment."

- here's the release

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