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AstraZeneca PLC (AZN) Faces Another R&D Setback as Plans to File for Early Approval for Cancer Med are Scrapped

11/10/2016 6:38:30 AM

AstraZeneca PLC Faces Another R&D Setback as Plans to File for Early Approval for Cancer Med are Scrapped November 10, 2016
By Alex Keown, Breaking News Staff

LONDON – The road for early approval of AstraZeneca PLC (AZN)’s durvalumab as a treatment of head and neck cancer has gotten a little bit longer.

In the company’s third-quarter report issued this morning, AstraZeneca said it will not seek early approval for durvalumab as a treatment for the cancer. The announcement came two weeks after the U.S. Food and Drug Administration placed a partial clinical hold on new patient enrollment to the company’s Phase III clinical trial of durvalumab for head and neck squamous cell carcinoma. The FDA slapped the partial hold onto the trial following reports of adverse events related to bleeding.

Buried in its third-quarter report, AstraZeneca said it would not seek early approval for durvalumab due to recent changes in the landscape of head and neck cancer treatment. That change was the August approval of Merck’s Keytruda, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Keytruda’s approval and the partial clinical hold have dampened AstraZeneca’s enthusiasm for entering the head and neck cancer market with durvalumab.
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“With recent changes in the HNSCC competitive landscape, including the approval in the U.S. for PD-1 monotherapy for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, the company is unlikely to make a regulatory submission for this single-arm Phase II trial. This trial in PD-L1+ patients was originally designed as a potential fast-to-market opportunity in 2nd-line HNSCC,” AstraZeneca said in its statement.

Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. By inhibiting PD-L1, durvalumab helps increase T-cell activity against the tumor to counter its efforts to evade the immune system, according to AstraZeneca. In 2015, durvalumab received Fast Track Designation for the treatment of patients with PD-L1-positive metastatic HNSCC.

AstraZeneca is investigating durvalumab as a monotherapy treatment for HNSCC, as well as in combination with tremelimumab and other drugs for other cancers.

Although the partial clinical hold was placed on the durvalumab HNSCC trial, the company said patients already in the trial will continue to receive doses. Additionally, there are other durvalumab trials being conducted for different cancers – either as a combination treatment or a monotherapy – are continuing unimpeded, the company said.

AstraZeneca has had some issues with durvalumab before. The company halted two clinical trials testing the combination of its experimental AZD9291 and durvalumab for lung cancer following reports of patients developing interstitial lung disease-like problems in one trial.

Shares of AstraZeneca are down more than 4 percent this morning following the company’s announcement this morning.

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