AstraZeneca's '$3B' lung cancer drug impresses in a Phase II race with Clovis

AstraZeneca's ($AZN) in-development lung cancer pill extended survival by more than a year in new Phase II data, a positive sign for a drug the company believes can bring in $3 billion in annual sales at its peak.

The treatment, AZD9291, charted a median progression-free survival of 13.5 months in patients with non-small cell lung cancer and EGFR mutations. The updated data come from AstraZeneca's ongoing Phase II study on nearly 300 patients, besting the 9.6-month PFS rate the company reported last fall. The drug also clocked a 54% overall response rate and a median duration of response of 12.4 months, AstraZeneca said.

AstraZeneca is raising with rival Clovis Oncology ($CLVS), whose lung cancer-treating CO-1686 also works by targeting EGFR. In November, Clovis reported a Phase II PFS rate of 10.4 months, disappointing analysts hoping for something closer to a year. The two companies are expected to reach the market around the same time and contend for dominance, and AZD9291's latest results sent Clovis' shares down about 4% on Friday morning.

For AstraZeneca, the positive data affirm the company's plan to submit regulatory applications for AZD9291 next quarter, and the company is pressing on with additional studies testing the drug in early-stage lung cancer and in combination with other oncology assets. The FDA has bestowed its breakthrough-therapy designation on AZD9291, promising a speedy review once the drug is filed.

The treatment is a major cog in AstraZeneca's promise to deliver annual revenue above $45 billion by 2023, a number bandied about when the company was fighting off an advance from Pfizer ($PFE) last year. AstraZeneca has affixed a $3 billion figure to AZD9291, a $6.5 billion peak expectation for the PD-L1-blocking immunotherapy MEDI4736 and a $2 billion tag on the PARP inhibitor olaparib, approved last year as Lynparza.

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