April 26, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – While AstraZeneca celebrates its expected 2016 opening of the company’s new global headquarters and R&D site, the company quietly pushed back its timeline for a late-stage lung cancer trial.
This morning, Reuters said that expected readouts from AstraZeneca’s third-line lung cancer ARCTIC trial has been moved to November from the first half of this year. Citing a company spokesperson, Reuters said the trial’s delay was due to a lack of observable clinical events in patients during the trial. Eligible patients are those with locally advanced or metastatic non-small-cell lung cancer, according to the trial abstract.
The Phase III trial is assessing the anti-PD-L1 antibody durvalumab as both a stand-alone and a combination treatment with tremelimumab, an anti-cytotoxic T-lymphocyte antigen 4 antibody, can increase overall survival or delay a worsening of lung cancer as a third-line treatment. As a third-line treatment, the patient population is rather small, Reuters noted, but could be worth billions if it meets endpoints and passes regulatory muster. The trial is evaluating whether the drugs offer the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status.
While the ARCTIC trial has been delayed, most investors are watching the MYSTIC trial, which is assessing the efficacy of the same drugs as a first-line treatment in lung cancer. The primary endpoints of AstraZeneca’s Phase III MYSTIC trial for its first-line lung cancer treatment was restructured in January. The trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS). However, now the trial will assess PFS and overall survival endpoints in patients with PDL1-expressing tumors for both durvalumab monotherapy and the combination of durva + treme, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy, the company said.
Some analysts have called the MYSTIC trial a gamble, particularly since Bristol-Myers Squibb already shuttered two similar trials.
AstraZeneca is looking for new revenue streams as it faces challenges from generic drugs. Earlier this year, the company said revenue will likely decline in 2017 due to those generic challenges, particularly as generic drugs eat into the marketshare of its blockbuster anti-cholesterol drug Crestor. In addition to its durvalumab trials, AstraZeneca is also hoping to expand the use of its PARP inhibitor, Lynparza. In February, the company announced Lynparza in tablet form met primary endpoints in a Phase III trial to treat patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations. If approved for this type of breast cancer, Lynparza will be the first PARP inhibitor for that type of cancer. Lynparza has already been approved by the U.S. Food and Drug Administration for the treatment of one form of ovarian cancer. In 2016, the drug generated $218 million for AstraZeneca.
