BeyondSpring presents efficacy results from Phase 2 IIT study of plinabulin

BeyondSpring (BYSI) announced that phase 2 IIT data on the first 30 patients dosed with plinabulin in the 303 Study of patients with non-small cell lung cancer after disease progression on PD-1/PD-L1 inhibitors with and without chemotherapy were presented at the 39th Society for Immunotherapy of Cancer’s Annual Meeting on November 8th, 2024 in Houston, Texas. Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations who progress on immune checkpoint inhibitors with and without standard chemotherapy. In the recent TROPION Lung-01 phase 3 studies, a similar patient population had an overall response rate of 12.8% and median PFS of 3.7 months. In metastatic NSCLC resistant to previous PD-1/L1 therapy1, PD-L1 and CTLA-4 inhibition alone or in combination with hypofractionated radiotherapy produced limited clinical benefits with ~11.5% ORR. This investigator-initiated, single-arm, open-label, phase 2 study evaluates the efficacy and safety of a triple combination regimen of pembrolizumab plus plinabulin/docetaxel. The study intends to enroll a total of 47 patients and is ongoing at Peking Union Medical College Hospital, Beijing, China with the principal investigator Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine. Here, we report on updated results from 30 patients. At the database lock on 29 August 2024, 36 patients were enrolled, 30 exposed to the plinabulin regimen. Prior to entry, all patients had experienced disease progression after initial clinical benefit with ICI. Of the 30 treated patients, 73.3% were male and 26.7% were female; 60% were current or former smokers. Histology included 57% patients with non-squamous cell carcinoma and 43% with squamous cell carcinoma. The median follow-up was 11.5 months. The combination was generally well tolerated. 46.7% of patients experienced grade 3 or higher treatment-related adverse effects. Most common AE is myelosuppression, GI side effect, and transient hypertension. There were no treatment-related deaths. Results are consistent with the data reported on the first 19 patients in Study 303 at ESMO in September.