BeyondSpring presents final data analysis of DUBLIN-3 Phase 3 study

BeyondSpring presented final data on Dublin-3 study focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study was published on September 9, 2024 in the Lancet Respiratory Medicine. Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations despite severe neutropenia that greatly impair patients’ quality of life. Six recent phase 3 studies in patients with EGFR wild-type NSCLC who were previously treated with immune checkpoint inhibitors failed to show overall survival benefit compared with docetaxel. Two phase 3 studies showed positive but mixed outcomes compared with docetaxel. The DUBLIN-3 study was a multicenter, single-blinded, randomized controlled trial that enrolled patients from 58 medical centers across Australia, China, and the USA. 559 patients with epidermal growth factor receptor wild-type NSCLC were randomly assigned to receive either docetaxel and plinabulin or docetaxel and placebo. The plinabulin/docetaxel combination significantly improved overall survival, progression-free survival, and objective response rate compared to docetaxel alone. This poster presentation focused on plinabulin and docetaxel combination safety vs. docetaxel alone, as shown below: The combination is well tolerated: Similar percentages of patients experienced greater than or equal to1TEAE; 99.6% in the combination arm and 99.3% in the docetaxel arm. There was less grade 4 TEAE in the combination arm vs. 42.8% in the docetaxel arm. The combination had greater than80% relative reduction in Grade 4 neutropenia: The combination arm had a 5.3 % Grade 4 neutropenia in Cycle 1 Day 8 compared to 27.8% in docetaxel alone. The combination arm had a 5.1 % Grade 4 neutropenia in all cycles Day 8 compared to 33.6% in docetaxel alone. In addition, hospital admission due to febrile neutropenia was lower in the combination arm vs. docetaxel arm. The combination had reduced use of granulocyte-colony stimulating factor in all cycles: Post-hoc analysis showed reduced G-CSF use in the combination arm vs. docetaxel arm and at cycles 1 to 4. The combination had improved quality-of-life based on Q-TWiST data: Exploratory analysis showed better QoL based on Q-TWiST in the combination arm, with a clinically meaningful relative gain to the docetaxel arm of 18.5%. The combination had a significant reduction in cycle-adjusted serious adverse events: Patients randomized to the combination received more cycles of treatment. When cycles were adjusted for SAEs, plinabulin significantly decreased Grade 3/4 SAEs and Grade 4 SAEs. The combination had manageable side effects: Plinabulin induced mostly asymptomatic transient hypertension, which mostly resolved within 4-6 hours after infusion without medication. In addition, plinabulin induced GI side effects, including nausea, vomiting, and diarrhea, which were effectively managed following a protocol adjustment to add the prophylactic use of antiemetics and increase time of infusion.