AstraZeneca said Friday that preliminary mid-stage study results from the ATLANTIC trial are unlikely to support regulatory filings for the anti-PD-L1 therapy durvalumab as a monotherapy in lung cancer. Sean Bohen, chief medical officer at the company, noted "the treatment and regulatory landscape in lung cancer is evolving," adding that AstraZeneca will make a determination regarding filings for durvalumab, also known as MEDI4736, "following a full analysis of the data."
The ATLANTIC study investigated durvalumab as a third-line or later stage therapy in patients with locally advanced or metastatic PD-L1 positive non-small-cell lung cancer (NSCLC) that lacks EGFR or ALK alterations. AstraZeneca noted that "an initial analysis supports durvalumab's clinical activity, with durable responses and an established safety profile in these difficult-to-treat patients."
Specifically, the study evaluated the safety and efficacy of the drug in patients who received at least two previous systemic treatment regimens, including platinum-based chemotherapy, and who have limited options for future treatment. AstraZeneca said an analysis of the study data is ongoing, while results will be presented at a research conference next year.
Bohen described durvalumab as "a cornerstone of our immuno-oncology portfolio" with a "development programme focused primarily on novel combinations." The drugmaker is currently evaluating the therapy in combination with Pfizer's investigational IgG2 monoclonal antibody tremelimumab in the treatment of several malignancies, including NSCLC, bladder cancer and head and neck cancer.
Durvalumab is also undergoing testing in the Phase III CAURAL study in combination with AstraZeneca's Tagrisso (osimertinib), which the FDA approved last month for certain patients with advanced NSCLC, as a potential second-line treatment for T790M mutation-positive NSCLC. In October, the company temporarily halted the CAURAL study, as well as the early-stage TATTON study, which is also evaluating durvalumab in combination with Tagrisso, formerly known as AZD9291, after an increase in the incidence of interstitial lung disease-like reports was observed in the trials.
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