Drug Combination Reduces Adverse Events and Need for Dose Reductions

The addition of plinabulin to non-small cell lung cancer (NSCLC) treatment with docetaxel may reduce the frequency of adverse events and help prevent dose reductions due to toxicity, according to an abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (June 3-7, 2016).

Docetaxel has shown effectiveness at helping to extend survival in patients with NSCLC after the failure of first-line chemotherapy; however, the drug is also associated with a relatively unfavorable toxicity profile that can limit its use and lead to significant adverse events. To address this issue, an investigational therapy, plinabulin, is being developed by BeyondSpring Pharmaceuticals to be used in combination with docetaxel to provide a regimen with an improved safety profile.
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In a phase 2 trial, investigators led by Ramon Mohanlal, MD, PhD, MBA, chief medical officer at BeyondSpring Pharmaceuticals, compared the safety and efficacy of docetaxel plus plinabulin (n=90) with docetaxel alone (n=73) in patients with NSCLC entering second- or third-line therapy.

Efficacy results for this combination were presented at the 2014 annual meeting of ASCO (May 30-June 3; Chicago, IL), which showed that the combination of the two drugs produced a duration-of-response that was almost 12 times higher than docetaxel alone (12.7 months vs 1.5 months, respectively).

At the 2016 meeting, investigators will present safety results from the trial, which found that using the drugs together led to significant reductions in grade 3 or 4 neutropenia (7% vs 25%) and asthenia (13% vs 28%) and reduced the use of granulocyte-colony stimulating factor (14% vs 29%).

Further, in what investigators called the most important finding, the addition of plinabulin also significantly decreased the need for docetaxel dose reductions due to toxicity compared with patients treated with docetaxel alone (6% vs 20%).

Thus, the investigators concluded that preliminary results indicate a potential efficacy benefit of using plinabulin with docetaxel over docetaxel alone. A phase 3 trial of the combination is currently underway in the United States, China, Australia, and New Zealand.