AstraZeneca Plc AZN announced positive overall survival (OS) results from the phase III CASPIAN study evaluating Imfinzi (durvalumab) in first-line extensive-stage small cell lung cancer (SCLC), the most aggressive type of lung cancer.
Data from an interim analysis conducted by an Independent Data Monitoring Committee showed that the study met its primary endpoint, as Imfinzi combined with standard-of-care medicine, etoposide, and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy alone.
This is the first study that offers the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options.
Imfinzi, a PD-L1 inhibitor, is presently approved for unresectable, stage III NSCLC in second-line setting in the United States. The company is evaluating the drug in several late-stage studies for treating stage IV NSCLC. The drug is also approved for the treatment of bladder cancer.
AstraZeneca’s shares are up 10.3% so far this year compared with the industry’s growth of 4.3%.
Imfinzi in being studied in other SCLC studies as well. It is being tested following concurrent chemoradiation therapy in limited-stage SCLC in the phase III ADRIATIC study.
Meanwhile, other than SCLC, key phase III trials are evaluating Imfinzi in combination with tremelimumab for hepatocellular carcinoma (HCC, liver cancer), NSCLC, and head and neck squamous cell carcinoma.
However, the drug is significantly lagging other approved PD-L1 inhibitors — Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda — in terms of approved indications and sales. While Imfinzi recorded sales of $371 million in the first nine months of 2018, Opdivo and Keytruda generated $4.9 billion and $5 billion, respectively. Notably, Keytruda and Opdivo were launched much earlier than Imfinzi. Other PD-L1 inhibitors in the market are Pfizer’s PFE Bavencio and Roche’s Tecentriq.
Earlier this month, Keytruda received FDA approval for metastatic SCLC in third- or later-line setting. This approval marks the first label expansion for Keytruda in the SCLC indication.
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AstraZeneca 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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