Alongside its Q3 results today AstraZeneca ($AZN) announced that it was dropping plans to gain an early regulatory review for its checkpoint inhibitor durvalumab in head and neck cancers.
The decision comes after the U.K.-based Big Pharma announced two weeks ago that the FDA had placed a partial clinical hold on the PD-L1 candidate due to bleeding adverse events in two clinical trials, specifically restricting the pharma from adding new patients for durvalumab in head and neck squamous cell carcinoma (HNSCC).
In a brief update buried within its Q3 financials, Astra said: “With recent changes in the HNSCC competitive landscape, including the approval in the U.S. for PD-1 monotherapy for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy [Merck’s Keytruda], the company is unlikely to make a regulatory submission for this single-arm Phase II trial.”
This trial in PD-L1 positive patients was originally designed as a potential “fast-to-market” op for the company in a second-line HNSCC setting, but Merck’s ($MRK) fall FDA approval, as well as the setback in testing, has pulled back these plans.
Last year, AstraZeneca CEO Pascal Soriot cautioned analysts to expect delays in its checkpoint inhibitor program, saying that regulators are less likely to feel an urgent need to approve new checkpoint drugs now that the first are on the market.
The so-called HAWK study results are anticipated to be available internally to AZ “in due course,” the company said, following trial conclusion and data analysis.
The partial clinical hold on new patient enrollment relates only to HNSCC, with trials for durvalumab in different cancer types ongoing.
The most important among these is the pivotal data in lung cancer, which is slated to come out in the first half of 2017.
In February, durvalumab won breakthrough therapy designation from the FDA to treat urothelial bladder cancer.
The only FDA-approved PD-L1 inhibitor is Roche’s ($RHHBY) Tecentriq (atezolizumab), which gained approval in May to treat urothelial bladder cancer.
The co was down 3.6% premarket this morning on the news, nixing the 3.4% it was up yesterday.