AstraZeneca has received approval for its cancer therapeutic, Imfinzi, by the US FDA for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC).
The injectable is suitable for those whose disease hasn't progressed post platinum-based chemotherapy and radiation therapy.
Imfinzi's approval follows AstraZeneca's securement of Priority Review and Breakthrough Therapy Designation for the drug, and was primarily based on the results from the ADRIATIC Phase III trial.
The ADRIATIC trial findings
Published in the New England Journal of Medicine, Imfinzi was found to reduce the risk of death by 27% versus placebo, while the estimated median overall survival (OS) was 55.9 months compared with the 33.4 month figure for the placebo group.
Three years after treatment with Imfinzi, approximately 57% of patients given the drug were alive.
Notably, 46% of patients had not experienced disease progression two years after their treatment with the therapeutic.
Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and international coordinating investigator in the trial, said: “Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer."
"This finding represents the first advance for this disease in four decades. The ADRIATIC trial showed 57 percent of patients were still alive at three years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval for Imfinzi marks a breakthrough for patients with limited-stage small cell lung cancer, allowing them to receive immunotherapy for the first time."
"The ADRIATIC trial showed an improvement in median overall survival of 22.5 months, setting a new benchmark. Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage small cell lung cancer, underscoring our commitment to improving survival rates.”
Imfinzi's safety profile was considered manageable and consistent in the ADRIATIC Phase III trial, and no new safety concerns were observed during the study period.
The Swiss regulatory board has also approved Imfinzi in this indication based on the results of the ADRIATIC study.
AstraZeneca's Imfinzi is currently under review in Japan, the EU and a number of other countries globally.