AstraZeneca announced Nov. 22 that the U.S. Food and Drug Administration has lifted the hold concerning new patient enrollment for head and neck squamous cell carcinoma (also known as HNSCC) clinical trials involving durvalumab as monotherapy.
The Phase III KESTREL trial is now open for patient enrollment again, with recruitment for the EAGLE trial also likely resuming. Those taking part in the HNSCC trials will be chosen from participating sites from the United States as well as the rest of the world.
Side Effects - Bleeding Incidents
As a series of patients were found to experience bleeding during a routine safety monitoring process carried out as part of the Phase III KESTREL and EAGLE trials, a hold was put on new recruitment, which was made public on Oct. 27.
AstraZeneca explained the situation by saying that bleeding is a known complication in head and neck cancer treatment, which may be attributed to previous cancer therapies used, tumor proximity to major blood vessels and the underlying nature of the disease.
While the company's statement mentioned that the decision was voluntary, a series of media sources explained that the company may have been forced to put a partial hold on the cancer trials.
The FDA decided to lift the hold order after a review was submitted by AstraZeneca representatives.
AstraZeneca - Ongoing Trials
Durvalumab, an immunotherapy candidate drug being tested as part of these trials, is expected to be the biggest source of income for the company in the following decade.
"Durvalumab is expected by the turn of the decade to be the biggest single contributor to AstraZeneca's sales, about half of which will come from the oncology pipeline, Jefferies has forecast," said the Financial Times.
The partial hold on the company's trial has affected both the finances and the image of AstraZeneca; however, as the hold was lifted, the treatments will most likely recover in popularity.
Head And Neck Cancer Statistics
Head and neck cancers include cancers of the nose/nasal passages, salivary glands, pharynx, larynx and oral cavity, accounting for about 3 percent of all malignant cases in the United States. Overall, the incidence of head and neck cancers has decreased, with overall mortality rates dropping since 2001.
Alcohol and tobacco use are the most important of risk factors for most cases of head and neck cancers, but certain human papillomavirus (HPV) infections, like HPV18 and HPV16, are also considered. No standard way exists to routinely screen for head and neck cancers.