AstraZeneca’s AZN Imfinzi (durvalumab) monotherapy as well as in combination with tremelimumab failed to meet overall survival (“OS”) endpoint in phase III MYSTIC study evaluating it in first-line stage IV (metastatic) non-small cell lung cancer (“NSCLC”).
Imfinzi, a PD-L1 inhibitor, is approved for unresectable, stage III NSCLC in second-line setting in the United States and the company is evaluating the drug in several late-stage studies for treating stage IV NSCLC. The drug is also approved for treating bladder cancer.
Shares of the company were down 1.8% on Nov 16 following the news. AstraZeneca’s shares are up 17.2% so far this year compared with the industry’s increase of 8.2%.
The MYSTIC study was evaluating Imfinzi monotherapy, and combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, compared with standard-of-care platinum-based chemotherapy in NSCLC patients who did not receive any previous treatment. The patients who were selected for analysis had their tumors expressing PD-L1 on 25% or more of their cancer cells.
Data from the study showed neither Imfinzi monotherapy nor Imfinzi combo achieved improvement in OS of statistical significance compared with chemotherapy.
In fact, data from the study last year indicated that Imfinzi as monotherapy or in combination with tremelimumab had failed to improve progression-free survival. Moreover, the OS data was expected in the first half of 2018 but a delay in the data readout was announced in March.
Imfinzi is a key drug in AstraZeneca’s immuno-oncology (“IO”) pipeline which is being evaluated for treating multiple cancers as monotherapy or in combination with other regimens including Incyte’s INCY epacadostat. Key phase III trials are valuating Imfinzi 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.
Successful completion of the MYSTIC study and approval for the first line indication could have helped AstraZeneca in bolstering the sales of the drug significantly as first-line lung cancer is a lucrative market. However, three other phase III studies – PEARL, NEPTUNE and POSEIDON – are evaluating the drug alone or in combination with tremelimumab in first-line NSCLC.
Meanwhile, the company’s PD-L1 inhibitor is significantly lagging the other two approved PD-L1 inhibitors – Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda – in terms of approved indications as well as sales. While Imfinzi recorded a sales of $371 million in the first nine months of 2018, Opdivo and Keytruda generated sales of $4.9 billion and $5 billion, respectively.
Although, Imfinzi’s development did not progress well in 2018, there are several data readouts scheduled in 2019. Positive data should boost the prospects of the drug and help it achieve the potential it holds as a PD-L1 inhibitor.
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AstraZeneca carries a Zacks Rank #3 (Hold).
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