The DUBLIN-3 Study: The Treatment Combination of Plinabulin, Docetaxel is Effective at Treating NSCLC

Patients with wild-type EGFR non-small cell lung cancer (NSCLC) who are treated with plinabulin combined with docetaxel experience improved survival and reduced severe neutropenia, according to a study presented at the IASLC 2024 World Conference on Lung Cancer.

In this multicenter, single-blinded, randomized phase 3 trial conducted in 58 medical centers across the US, China, and Australia, researchers analyzed patients with wild-type EGFR NSCLC who progressed after first-line platinum-based therapy. Overall, 559 patients received either docetaxel plus plinabulin (n=278) or docetaxel plus placebo (n=281). The primary endpoint of interest was defined as overall survival (OS) in the intent-to-treat (ITT) population.

The results showed that plinabulin significantly improved OS; the hazard ratio (HR) was 0·82 (95% CI: 0·68, 0·99; P=·0399) in the final analysis. The median OS in the plinabulin group was 9·4 months (95% CI: 8·38, 10·68). With an additional 24-month follow-up after database lock, the researchers observed an OS benefit sustained in the ITT population with median OS favoring the plinabulin group (10.8 vs 9.3 months, HR=0.81, P=.0027) and more pronounced in the non-squamous population (11.4 vs 8.8 months, HR=0.72, P=.0078).

Moreover, the results showed that the objective response rate (ORR) was significantly higher in the plinabulin group with 39 patients (14·0%), as this cohort achieved partial responses compared to 24 patients (8·5%) in the control group (difference: 5·5%, 95% CI: 0·26, 10·72, P=·0404). Furthermore, the researchers observed OS benefits with more treatment cycles (≥4, 6, 8, 10, or 12 cycles), suggesting a durable anti-cancer benefit with plinabulin.

“In patients with advanced EGFR wild-type platinum refractory NSCLC, plinabulin combined with docetaxel was well-tolerated and statistically significantly improved OS/PFS/ORR with reduced severe neutropenia. A durable anti-cancer benefit was observed suggesting that plinabulin/docetaxel as a potential practice-changing treatment for advanced/metastatic NSCLC without driver mutations,” the researchers concluded.

Reference

Feinstein T, Han B, Shi Y, et al. Plinabulin/Docetaxel vs. Docetaxel in 2L/3L NSCLC after Platinum Regimens (DUBLIN-3): A Phase 3 Randomized Controlled Trial. OA08.04. Presented at the IASLC World Conference on Lung Cancer; September 7-10, 2024; San Diego, California.