Phase 2 trial of plinabulin (NPI-2358) for the treatment of advanced non-small cell lung cancer (NSCLC)

Nereus Pharmaceuticals announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC). This trial, also known as ADVANCE (Assessment of Docetaxel and Vascular Disruption in Non-Small Cell Lung Cancer), is investigating plinabulin in combination with docetaxel compared to docetaxel alone in patients with advanced NSCLC who previously failed at least one prior chemotherapy regimen. Overall survival is the primary endpoint of the trial, and progression free survival and tumor response rates are being evaluated as secondary endpoints. Approximately 150 patients are expected to participate in the study at clinical trial sites in the U.S., Australia, India, and South America, of which 110 have been enrolled.

The interim results from the trial indicated that the combination of plinabulin and docetaxel is tolerable, and suggested that the plinabulin combination improves tumor response rate by demonstrating that out of 57 evaluable patients an estimated 26 percent of those treated with plinabulin and docetaxel had a greater than or equal to 30 percent shrinkage of tumors (standard response criteria) compared to 3 percent of those treated with docetaxel alone.

The VDA, plinabulin, is one of over 200 synthetic analogues that were prepared following the discovery of the compound Halimide isolated from a marine fungus. Plinabulin has a dual effect on tumors: it selectively attacks existing tumor blood vessels leading to hemorrhagic tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumor cells.

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