AstraZeneca plc (ADR) (NYSE:AZN) Retreats On Some Durvalumab Plans

A sign is seen at an AstraZeneca site in Macclesfield
A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Britain's Prime Minister David Cameron said the government would continue to talk to both Pfizer and AstraZeneca after the British drugmaker on Monday rejected a sweetened offer from the U.S. company. REUTERS/Phil Noble (BRITAIN - Tags: BUSINESS HEALTH)

AstraZeneca plc (ADR) (NYSE:AZN) will no longer seek early regulatory review of its drug candidate durvalumab in patients with head and neck cancers. Durvalumab is a checkpoint inhibitor (PD-L1) that is also being studied as a potential treatment for other forms of cancers including lung cancer and urothelial bladder cancer.

Story continues below

As per an earlier update, AstraZeneca had said that it was interested in pursuing accelerated regulatory review of the candidate specifically for head and neck squamous cell carcinoma (HNSCC) so that it could bring it to market quickly. But with the FDA already having approved a checkpoint inhibitor for HNSCC and durvalumab suffering trial setbacks in HNSCC patients, AstraZeneca has decided to abandon the plans to seek accelerated review of the candidate.

FDA clinical hold roils waters for AstraZeneca

AstraZeneca’s retreat on durvalumab comes on the heels of a regulatory warning on the candidate. The FDA recently issued a partial clinical hold on durvalumab because of adverse events involving bleeding. Specifically, the regulator has stopped AstraZeneca from enlisting new patients into the study of durvalumab for HNSCC.

AstraZeneca was hoping to be fast to market with its durvalumab for HNSCC patients. But rival Merck & Co., Inc. (NYSE:MRK) pulled ahead with fall FDA approval of its candidate. The loss of the race to market to Merck combined with the clinical hold has slowed down AstraZeneca.

Other programs to continue

The FDA’s clinical hold on durvalumab only affects its testing on HNSCC patients. As such, AstraZeneca is free to continue with the trial of the drug for lung cancer and urothelial bladder cancer. The company sees opportunity in the urothelial bladder cancer treatment market considering that Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) is the only one with an FDA-approved PD-L1 inhibitor.

As for lung cancer, a study is ongoing and results are expected in early 2017.


3Q16 earnings

AstraZeneca reported that its net profit rose 32% to $1 billion in 3Q16, but revenue declined 4% to $5.7 billion. Analysts were looking for a net profit of $731 million on revenue of $5.87 billion.

AstraZeneca stock is down more than 18% YTD.

An ad to help with our costs