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.
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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.
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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 PLC (ADR) (NYSE:AZN) 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 plc (ADR) (NYSE:AZN) 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.
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Note: This article is written by Andy Parker and was originally published at Market Exclusive.
Update: A representative of the company sent the following clarification:
“The article’s summary is somewhat misleading on two counts, hence I write to ask for your support in amending the text to clarify.
– The article gives impression the company has abandoned plans for durvalumab in head and neck cancer, which is not the case. We have a mature HNSCC programme through late-stage trials CONDOR, KESTREL and EAGLE. I attach below a slide that shows these in summary timeline. What we commented on at our Q3 financial results call on Thursday was regarding HAWK trial. With recent changes in the HNSCC competitive landscape, including the approval in the US for PD-1 monotherapy for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, we are 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. The HAWK trial results are anticipated to be available internally in due course, following trial conclusion and data analysis.
– The other confusion is the take-out that that the above is off the back of the recently communicated partial clinical hold by FDA on the enrolment of new patients in durvalumab HNSCC trials. The two are not linked at all.”
