BeyondSpring reports first patient dosed with pembrolizumab, plinabulin plus EP

BeyondSpring announced that the first patient has been dosed in a Phase 2 investigator-initiated trial with Pembrolizumab, Plinabulin, BeyondSpring’s lead asset, plus Etoposide/Platinum for first-line Extensive-Stage Small-Cell Lung Cancer. Current treatment for first-line ES-SCLC includes EP and EP plus PD-L1 antibodies. Although the objective response rate is high, median progression free survival remains low with median overall survival at 10-13 months. Therefore, 1L ES-SCLC remains a serious unmet medical need. Plinabulin, a potent dendritic cell maturation agent3, has been studied in a triple combination with various immuno-oncology agents and chemotherapy or radiation, with the potential to enhance the efficacy of PD-1/PD-L1 blockade and restore sensitivity in patients who become resistant. Preliminary re-sensitization data in PD-1/PD-L1 antibody failed patients in 8 cancer types corresponding response with Plinabulin DC maturation was presented at SITC conference in Nov 20234. This Phase 2 trial will evaluate the efficacy and safety of Pembrolizumab, Plinabulin plus EP in 1L ES-SCLC. The study5 is conducted in Wuhan Union Hospital in China, with Dr. Xiaorong Dong, Deputy Director of the Oncology Research Department and Director of the Thoracic Oncology Department, as the principal investigator. Patients enrolled are receiving the following interventional treatments. The primary endpoint is the 12-month PFS rate.