According to the National Cancer Institute, approximately 220,000 patients are diagnosed with lung cancer in the United States per year. These lung cancers are typically divided into two groups based upon the histologic appearance of the tumor cells—small cell and NSCLC, which are treated with distinct chemotherapeutic approaches. NSCLC accounts for approximately 87% of lung cancer cases. The prognosis for patients with lung cancer is poor with five-year survival rates of only 17.7%. Lung cancer is the leading cause of cancer death in the United States, and a global health problem with approximately 1.8 million cases diagnosed per year. Approximately one-third of lung cancer patients worldwide are in China, with approximately 700,000 cases of lung cancer diagnosed in China in 2015.
Plinabulin in NSCLC
Data from the Phase 2 portion of the Phase 1/2 trial in NSCLC, which was highlighted at the 2017 ASCO-SITC conference, suggests that the addition of Plinabulin to docetaxel may increase anti-tumor activity compared to docetaxel alone. A subset of 38 patients with measurable lung lesions given a combination of docetaxel plus Plinabulin had a median survival of 11.3 months compared to 6.7 months in docetaxel alone and a median duration of response of 12.7 months in the combination arm, compared with 1.0 months in docetaxel alone (p<0.05). In addition, the Plinabulin treatment cohort showed a nearly double objective response rate (18.4% compared with 10.5%) compared to 10.5% for the docetaxel monotherapy arm, although the number of patients in the subset was not large enough to demonstrate statistical significance.
In pre-clinical studies, Plinabulin has also been associated with stimulation of the immune system and as an enhancer of the activity of other immune-oncology agents. Two investigator-sponsored U.S.-based Phase 1/2 trials of Plinabulin in combination with PD-1 inhibitor nivolumab in NSCLC is currently ongoing. BeyondSpring expects to initiate a global pivotal trial of Plinabulin in combination with nivolumab in 2018.