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AstraZeneca Offers Update on Immuno-Oncology Program

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AstraZeneca plc (AZN - Free Report) provided an update on its late-stage immuno-oncology program for first-line non-small cell lung cancer (NSCLC), including amendments of the MYSTIC study, expansion of the NEPTUNE study and initiation of the new PEARL study.

Shares of AstraZeneca have underperformed the Zacks classified Large Cap Pharmaceuticals industry in the past one year, with the stock losing 3.5% while the industry witnessed an increase of 4.3%.

Modifications in MYSTIC

The phase III MYSTIC study was previously designed to evaluate the benefit of durvalumab (a PD-L1 human monoclonal antibody) monotherapy, and in combination with tremelimumab (durva + treme), compared with standard-of-care (SoC) chemotherapy, for progression-free survival (PFS). The study will now evaluate PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumors for both durvalumab monotherapy and the durva + treme combination, as well as in ‘all comers’ for the combination, compared with SoC chemotherapy.

Although the company will continue to focus on assessing the benefit of the durva + treme combination therapy, it has updated the endpoints of the study to include OS and PFS in durvalumab monotherapy based on recent internal and external data as well as significant opportunities in the competitive landscape. Data included strong efficacy demonstrated by durvalumab as monotherapy, which were presented recently at medical meetings.

Owing to these amendments, the estimated primary completion date has been updated to reflect both an increase in patient recruitment and the event-based nature of the study. AstraZeneca expects PFS data from the study in mid 2017 and final OS data in 2018 latest. MYSTIC also includes several undisclosed interim analyses for OS.

Expansion of NEPTUNE

AstraZeneca said that the ongoing phase III study, NEPTUNE, will be expanded to include local patients to support a regulatory submission for the durva + treme combination therapy in China for first-line NSCLC patients. However, the OS data readout expected in 2018 from the global cohort, which has advanced to full recruitment, will not be delayed.

Initiation of PEARL

AstraZeneca has commenced a new phase III study, PEARL, on durvalumab monotherapy, in comparison to SoC chemotherapy, for first-line NSCLC patients whose tumors express PD-L1. The study will focus on Asian countries, mainly China, due to high prevalence of NSCLC in the region. More than 1.1 million new cases of NSCLC have been projected for China alone in 2030.

We are encouraged by the latest update on durvalumab. The candidate is currently under priority review in the U.S. for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen. A response from the FDA is anticipated in the second quarter of 2017.

Note that in the U.S., durvalumab enjoys Breakthrough Therapy status for PD-L1 positive inoperable or metastatic UC, and Fast Track status for PD-L1 positive metastatic head and neck squamous cell carcinoma.

Durvalumab is being evaluated under a broad development program across multiple tumor types (including lung, bladder, head & neck and other cancers), stages of disease, and lines of therapy both as monotherapy and in combination. Of late, AstraZeneca has been looking to build its immuno-oncology portfolio and pipeline with strategic licensing and acquisition deals. The company’s target is to launch at least six new medicines between 2014 and 2020.

Similarly, other large cap pharma companies like Bristol-Myers Squibb Company (BMY - Free Report) and Merck & Co., Inc. (MRK - Free Report) are working on bringing innovative immuno-oncology treatments to market.

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

Astrazeneca PLC Price and Consensus

 

A Key Pick

Anika Therapeutics, Inc. (ANIK - Free Report) is better-ranked stock in this industry sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 35.3% in the past one year.

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