AstraZeneca's Imfinzi Gets China Nod For Stage III NSCLC

AstraZeneca (NYSE:AZN) announced that China’s National Medical Products Administration has granted marketing authorization for its PD-L1 inhibitor, Imfinzi (durvalumab). Following the approval, Imfinzi will be available for the treatment of unresectable, stage III non-small cell lung cancer (“NSCLC”) in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (“CRT”).

This is the first approval for Imfinzi and for any immunotherapy in this patient population in China. The drug is already approved for this patient population in 54 countries and regions, including the United States and Europe.

This year so far, AstraZeneca’s shares have risen 26.8% compared with the industry’s growth of 8%.

The approval was based on data from the phase III PACIFIC study, which evaluated platinum-based CRT followed by Imfinzi in patients with unresectable, stage III (locally advanced), regardless of PD-L1 status. Imfinzi was administered in patients whose disease has not progressed following the CRT. The regimen used in the PACIFIC study has become the global standard of care for the treatment of unresectable Stage III NSCLC.

The latest data from the PACIFIC study announced in June showed that more than half of the unresectable, stage III NSCLC patient population treated with Imfinzi was alive, following three years of treatment. The overall survival rate (“OS”) was 57% for patients treated with Imfinzi compared with 43.5% for placebo. Moreover, the drug was the only immunotherapy to demonstrate overall survival at three years in this patient population.

Imfinzi generated sales of $1.04 billion in the first nine months of 2019, up 182% year-over-year, mainly driven by strong demand in lung cancer patients. The approval in China is likely to boost sales further. The drug is set to achieve blockbuster status by this year.

Apart from the lung cancer indication, Imfinzi is also approved for second-line advanced bladder cancer. The company is also evaluating the drug for multiple cancers, either alone or in combination with other regimens, including phase III trials in combination with tremelimumab in hepatocellular carcinoma (liver cancer), in earlier settings in NSCLC, small cell lung cancer, metastatic urothelial cancer and head and neck squamous cell carcinoma among others.

Immunotherapies are the latest trend in cancer treatment and an effective one. However, we note that the immunotherapy segment for cancer indications is getting competitive with several approved immunotherapies including Merck’s (NYSE:MRK) Keytruda, Bristol-Myers’ (NYSE:BMY) Opdivo and Roche’s (OTC:RHHBY) Tecentriq. Several other pharma companies are also developing immunotherapies in different stages on clinical studies.

In a separate release, AstraZeneca and its Japanese partner, Daiichi Sankyo, announced detailed data from the phase II DESTINY-Breast01 study, evaluating their antibody drug conjugate candidate, trastuzumab deruxtecan, in third or late-line HER2-positive metastatic breast cancer. The companies had announced successful completion of the study in May.

Data from the study demonstrated that patients treated with trastuzumab deruxtecan monotherapy achieved an objective response rate of 60.9%. Disease control rate achieved by patients was 97.3%. Median duration of response and progression-free survival were 14.8 months and 16.4 months, respectively. The estimated overall survival at one year was 86%.

The companies are developing the candidate in five pivotal studies for several cancer indications including HER2-expressing metastatic breast and gastric cancer.

Zacks Rank

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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