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AstraZeneca's Imfinzi Gains Orphan Drug Status for SCLC

Zacks Equity Research

AstraZeneca PLC AZN announced that the FDA has granted an orphan drug designation to its PD-L1 inhibitor, Imfinzi (durvalumab), for the treatment of patients with extensive-stage small cell lung cancer (SCLC), the most aggressive type of the indication.

The orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States.

The prestigious status comes close on the heels of presentation of positive overall survival (OS) data from the phase III CASPIAN study, which evaluated Imfinzi for SCLC in June. The analysis met the primary endpoint as Imfinzi when combined with the standard-of-care medicine, etoposide and platinum-based chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in OS as compared to chemotherapy alone.

This is the first study that offers the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, thereby its expanding treatment options.

Shares of AstraZeneca have increased 6.5% so far this year, outperforming the industry’s rise of 2.8%.

Imfinzi is presently approved for unresectable, stage III NSCLC in second-line setting across the United States. The company is evaluating the drug in several late-stage programs for treating stage IV NSCLC. The drug also secured a nod for the treatment of bladder cancer.

Moreover, it is being developed under other SCLC studies. Currently, the medicine is being tested in the phase III ADRIATIC assessment following a concurrent chemoradiation therapy for the limited-stage SCLC.

SCLC constitutes about 15% of all lung cancer diagnosis and is a difficult disease to address as only 6% of patients is able to survive after five years of treatment.

Other than lung cancer, key phase III probes are evaluating Imfinzi in combination with tremelimumab for hepatocellular carcinoma, metastatic urothelial cancer and head and neck squamous cell carcinoma.

However, Imfinzi is significantly lagging other approved PD-L1 inhibitors, namely Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda in terms of recognized indications and sales.

While Imfinzi recorded sales of $295 million in the first quarter of 2019, Opdivo and Keytruda generated $1.8 billion and $2.27 billion, respectively, in the period. Notably, Keytruda and Opdivo were launched much ahead of Imfinzi. Other PD-L1 inhibitors in the market are Pfizer’s PFE Bavencio and Roche’s Tecentriq.

Zacks Rank

AstraZeneca currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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