AstraZeneca is to conduct a clinical trial on anti-cancer immunotherapy Imfinzi (ingredient: durvalumab) to treat metastatic, non-small cell lung cancer (NSCLC) patients, who have progressed on an anti- PD-1/PD-L1 containing therapy.
The Ministry of Food and Safety on Monday approved AstraZeneca Korea’s plan for phase-2 clinical trial on MEDI4736, the name of Imfinzi under the test.
The clinical trial will be an open-label, multi-drug, biomarker-directed, multi-center, phase-2, and an umbrella study on 45 metastatic NSCLC patients who have progressed in an anti-PD-1/PD-L1 containing therapy. An umbrella clinical trial offers customized treatments based on analysis of individuals’ genetic information.
Imfinzi is a treatment that inhibits the interaction between PD-L1 and PD80, aiming to obtain an indication for lung cancer.
Imfinzi is to compete against its rival anti-cancer immunotherapies such as Opdivo, Keytruda, and Tecentriq that are already performing well in the lung cancer treatment market.
AstraZeneca is a leader in lung cancer treatments, developing first-generation epidermal growth factor receptor (EGFR) targeted therapy Iressa (ingredient: gefitinib), and T790M mutation targeted therapy Tagrisso (ingredient: osimertinib). However, in anti-cancer immunotherapies development, the company is left behind, some critics said.
To accelerate Imfinzi’s market launch, AstraZeneca received approval from the U.S. FDA for treatment of bladder cancer (locally-advanced or metastatic urinary tract epithelial cancer) earlier this year. The move was a strategy to get the FDA approval first and expand indications. Keytruda also obtained approval for treatment of melanoma and aims to add indications such as lung cancer.
Imfinzi is likely to add lung cancer indication sooner or later, observers said. Based on a phase-3 clinical study “PACIFIC,” the drug is on the fast-track review list in the U.S. as a treatment for NSCLC. In October, AstraZeneca applied for sales approval for Imfinzi in Europe as an NSCLC treatment.
The PACIFIC trial was on 713 locally advanced unresectable NSCLC patients whose disease had not progressed following platinum-based chemoradiation therapy.
The study results showed that Imfinzi-administered patients had 16.8 months of none-progression survival period, 11.2 months more than the 5.6 months of the placebo-administered group.
AstraZeneca Korea is likely to request approval for Imfinze in Korea soon, observers said.
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