OncoGenex starts phase-3 trial of lung cancer drug

"ENSPIRIT" study of custirsen in metastatic non-small cell lung cancer to enroll about 1,100 patients

BOTHELL, Wash. — Drug maker OncoGenex Pharmaceuticals has started its third late-stage clinical trial of a drug for treating a type of lung cancer.

OncoGenex announced Friday the initiation of the phase-3 "ENSPIRIT" trial of custirsen in patients with nonsmall cell lung cancer that has spread to other parts of the body, also known as metastasis, and whose disease has progressed after initial treatment with chemotherapy has failed.

The trial, which will enroll about 1,100 patients, will combine custirsen with docetaxel, a common second-line chemotherapy drug in NSCLC.

"Despite breakthroughs in molecular targeting for advanced NSCLC, most patients require chemotherapy, and unfortunately, often progress to require second-line treatment," OncoGenex EVP and chief medical officer Cindy Jacobs said. "Given custirsen's enhancement of taxanes pre-clinically as well as with a wide range of anti-cancer agents, even in chemo-resistant models, we are eager to learn if custirsen can improve docetaxel outcomes in patients with progressive NSCLC."

The company is conducting two other phase-3 studies: "SYNERGY," which will evaluate custirsen in patients with castrate-resistant prostate cancer receiving first-line docetaxel chemotherapy; and "AFFINITY," which will investigate the drug combined with Sanofi's second-line chemotherapy drug Jevtana (cabazitaxel) in patients with CRPC.


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