According to the National Cancer Institute, an estimated 222,500 cases of lung cancer will be diagnosed in the United States in 2017, of which NSCLC accounts for approximately 87 percent of all lung cancer cases. The prognosis for patients with lung cancer is poor, with five-year survival rates of only 17.4 percent. Lung cancer is the leading cause of cancer death in the United States, and on a global basis, 1.8 million cases of lung cancer are diagnosed annually. China represents one-third of lung cancer patients globally, with approximately 700,000 cases diagnosed in China in 2015.
Despite the availability of multiple drugs to treat NSCLC, there remains a great need for new therapies in NSCLC, which is projected to be a $28 billion market by 2020. Currently marketed drugs for NSCLC have been limited by modest survival benefits, effectiveness only in certain genetic mutations, response to treatment by only a small set of patients, and unique safety risks across therapeutic modalities.
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.