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AstraZeneca: FDA Lifts Hold on Head & Neck Cancer Trials

AZN MRK INCY ANIK

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AstraZeneca plc (AZN - Free Report) announced that it has resumed enrolment of new patients in head and neck cancer studies of its lead pipeline candidate durvalumab as the FDA has lifted a partial clinical hold that it had imposed in October.

Late last month, durvalumab was placed on partial clinical hold by the FDA for head and neck squamous cell carcinoma (HNSCC). This meant that new patients could not be enrolled in studies evaluating only durvalumab or durvalumab in combination with its other pipeline candidate tremelimumab or other medicines for HNSCC. The hold did not affect studies evaluating durvalumab for other types of cancer.

The FDA placed a partial clinical hold after AstraZeneca decided to pause enrolment of new HNSCC patients while a detailed analysis of adverse events related to bleeding observed in a couple of phase III studies was being conducted. The analysis was submitted by the company to the agency. Based on the review of the comprehensive analysis, the FDA lifted the partial clinical hold.

While KESTREL phase III trials had already re-opened for new patient enrolment, the EAGLE trial is expected to resume recruitment shortly.

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). The candidate is being developed to strengthen patients’ immune system by blocking the PD-L1 interaction with PD-1, countering the immune-evading tactics of tumors.

We note that durvalumab is being evaluated in several studies for multiple cancers either alone or in combination with other regimens, including non-small cell lung cancer (phase III), and head and neck cancers among others. Pivotal data in lung cancer studies is expected to be released in the first half of 2017.

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the space include Merck & Co., Inc.  (MRK - Free Report) , Incyte Corporation (INCY - Free Report) and Anika Therapeutics (ANIK - Free Report) , all with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merck’s shares have increased 17% year to date. Its earnings estimates increased by 0.5% for both 2016 and 2017 over the last 30 days. The company posted a positive surprise in all the four trailing quarters, with an average beat of 4.30%. Its share price has increased almost 17% year to date.

Incyte’s earnings estimates increased from 20 cents to 68 cents for 2016 and from $1.42 to $1.68 for 2017 over the last 30 days. The company posted an average beat of 431.43% over the last four quarters.

Anika’s earnings estimates increased by 5% for 2016 and by 3% for 2017 over the last 30 days. The company posted a positive surprise in all the four trailing quarters, with an average beat of 33.14%. Its share price has gained 20.9% year to date.

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