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AstraZeneca's Final Data From Key Lung Cancer Study Delayed

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AstraZeneca, plc (AZN - Free Report) has announced that final overall survival data from the pivotal phase III MYSTIC study, evaluating its PD-L1 inhibitor Imfinzi in the first line lung cancer, will be presented in the second half of 2018, delayed from the first half expected previously.

The MYSTIC study evaluated Imfinzi, both as a monotherapy and in combination with tremelimumab, in treatment-naïve non-small cell lung cancer (NSCLC) patients.

AstraZeneca’s shares have inched up 0.2% so far this year, comparing unfavorably with the industry’s growth of 1.7%.


This is the second negative update from AstraZeneca in relation to the MYSTIC trial. Last July, the pharma company had reported about the study’s failure to meet its primary endpoint of progression-free-survival, sending the company’s shares tumbling.

The study showed that Imfinzi in combination with tremelimumab could not improve progression-free survival (PFS) when compared with platinum-based chemotherapy in patients, whose tumors express PD-L1 on 25% or more of their cancer cells. Imfinzi monotherapy also fell short of showing a benefit on PFS.

However, the MYSTIC study continued thereafter as planned to assess the additional primary endpoints of overall survival (OS) for both monotherapy and combination regimen. Final OS data from both primary endpoints were initially expected during the first half of 2018.

Imfinzi is a key drug in London-based AstraZeneca’s immuno-oncology (IO) pipeline, currently being evaluated for multiple cancers either alone or in combination with other regimens including Incyte’s (INCY - Free Report) epacadostat. Key phase III trials in combination with tremelimumab for hepatocellular carcinoma (HCC, liver cancer), NSCLC, small cell lung cancer and head and neck squamous cell carcinoma (HNSCC) among others are under way.

Imfinzi was launched in the United States for the first indication — second-line advanced bladder cancer — in May 2017. It was approved for the second indication in the United States — early stage lung cancer (NSCLC) — in February 2018. The drug generated sales of $19 million last year.

Talking about PD-L1 inhibitors, Merck’s (MRK - Free Report) Keytruda and Bristol Myers’ (BMY - Free Report) Opdivo have been notable successful launches. While Keytruda fetched in sales of $3.8 billion in 2017, up almost 172% year over year, Opdivo recorded $1.36 billion of revenues during the period, up 4%.

AstraZeneca carries a Zacks Rank #4 (Sell).

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