AstraZeneca (AZN - Free Report) announces that the phase III EAGLE study, evaluating Imfinzi (durvalumab) as monotherapy as well as a combination therapy with tremelimumab, failed to meet primary endpoint of improvement in overall survival (“OS”) in advanced head and neck squamous cell carcinoma patients compared to chemotherapy (“HNSCC”).
The study compared Imfinzi monotherapy and combination therapy to standard-of-care (SoC) chemotherapy in HNSCC patients whose disease has progressed following a platinum-based chemotherapy, regardless of their PD-L1 tumor status.
Data from the study showed neither Imfinzi monotherapy nor Imfinzi combo achieved improvement in OS compared with SoC chemotherapy.
We remind investors that Imfinzi and Imfinzi+ tremelimumab also failed in another late-stage study evaluating the therapies in first-line stage IV (metastatic) non-small cell lung cancer (“NSCLC”).
Imfinzi, a PD-L1 inhibitor, is marketed for unresectable, stage III NSCLC and metastatic urothelial carcinoma in second-line setting.
AstraZeneca’s shares are up 12% so far this year compared with the industry’s increase of 9.1%.
Although the drug failed in this HNSCC study, the company remains committed to developing it for the indication. Another late-stage study, KESTREL, is evaluating the same combination in HNSCC patients who have not received any prior chemotherapy. Data from this study is expected in the first half of 2019.
Per the press release, globally 880,000 patients were diagnosed with HNSCC in 2018 and about two-third of them are in advanced stages. This represents a significant opportunity for drugs that are being developed for this indication. However, with this failure of Imfinzi in second-line HNSCC, AstraZeneca is set to miss an opportunity to grab a share in the market. Investors should remain focused on KESTREL study data for Imfinzi’s prospects in this patient population.
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 - Free Report) epacadostat. Key phase III trials are evaluating Imfinzi in combination with tremelimumab for hepatocellular carcinoma (HCC, liver cancer), NSCLC, small cell lung cancer, HNSCC and bladder cancer.
The company’s PD-L1 inhibitor is significantly lagging the other two approved PD-L1 inhibitors — Bristol-Myers’ (BMY - Free Report) Opdivo and Merck’s (MRK - Free Report) Keytruda — in terms of approved indications as well as sales. While Imfinzi recorded sales of $371 million in the first nine months of 2018, Opdivo and Keytruda generated sales of $4.9 billion and $5 billion, respectively. Successful development of Imfinzi is necessary for AstraZeneca to grab the lucrative IO market.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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