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Custirsen plus docetaxel fails to extend OS in NSCLC

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The addition of custirsen to second-line docetaxel chemotherapy did not significantly extend OS in patients with advanced or metastatic non–small cell lung cancer that progressed after initial chemotherapy, according to results of the randomized phase 3 ENSPIRIT trial.

The open-label trial included 664 patients. Those assigned custirsen (OncoGenex) plus docetaxel achieved a median OS of 9 months, whereas those assigned docetaxel alone achieved a median OS of 7.9 months (HR = 0.91), according to an OncoGenex-issued press release.

Safety outcomes appeared consistent with those observed in prior trials designed to assess the combination of custirsen and chemotherapy.

Custirsen is a highly specific clusterin inhibitor designed to disable a fundamental cellular repair mechanism used by tumor cells, thereby extending survival in patients with advanced cancer.

Study results presented earlier this month at the European Society for Medical Oncology Congress in Denmark showed the addition of custirsen to cabazitaxel and prednisone did not significantly extend OS in previously treated patients with metastatic, castration-resistant prostate cancer.

“Following the negative results of previous custirsen trials, an early final analysis of the ENSPIRIT trial was conducted in an effort to conserve capital and extend our cash runway,” Scott Cormack, president and CEO of OncoGenex, said in the release. “We will continue to take appropriate steps to realize the most value for our shareholders once we receive the results of our apatorsen phase 2 Borealis-2 bladder cancer trial.”

Results of the randomized phase 2 Borealis-2 trial — designed to assess apatorsen (OncoGenex) plus docetaxel vs. docetaxel alone in patients with metastatic bladder cancer that progressed after first-line platinum-based chemotherapy — are expected by the end of October.