1410P - Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): Subgroup analysis from FRUTIGA study

Background

FRUTIGA has previously reported that F+PTX significantly improved PFS, ORR and DCR in 2L treatment of pts with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Treatment landscape of gastric cancer has evolved in the past few years. Immunotherapy plus chemotherapy with or without HER2-targeted therapy is the new standard of care for 1L therapy especially in pts with high PD-L1 expression, while the immunotherapy was not accessible in China at the initiation of FRUTIGA in 2017.

Methods

Pre-defined and post hoc analyses were conducted to evaluate the efficacy of F+PTX compared with placebo plus paclitaxel (PBO+PTX) in pts who received prior-IO in FRUTIGA.

Results

Of the 703 pts enrolled in FRUTIGA, 82 had received prior-IO. Of these, 35 were treated with F+PTX and 47 with PBO+PTX. Baseline demographics and disease characteristics were comparable between treatment arms. The most commonly used prior-IO were sintilimab (20.7%) and tislelizumab (19.5%). PFS was longer with F+PTX versus PBO+PTX (mPFS, 6.4 vs 1.8 months, HR 0.38; p=0.0003). Higher ORR and DCR were also observed in F+PTX (57.1% vs 19.1% and 82.9% vs 42.6%, respectively) compared with PBO+PTX. However, OS was not statistically significant (mOS, 12.1 vs 10.3 months, HR 0.99). It showed the same benefit trends of PFS, ORR and DCR in pts with prior-IO, in consistent with ITT population. Pre-defined subgroup analysis showed that pts with prior-IO might further reduce the risk of death or progression (HR 0.38) compared with those received prior chemotherapy only (HR 0.62) or the ITT population (HR 0.57). Detailed information is provided in the table. Table: 1410P

Conclusions

F+PTX also demonstrated efficacy benefits and showed great clinical value in prior-IO exposed pts.

Clinical trial identification

NCT03223376.

Editorial acknowledgement

Legal entity responsible for the study

Hutchmed Limited.

Funding

The National Science and Technology Major Project (project no. 2019ZX09301012), the Science and Technology Commission of Shanghai Municipality (Science, Technology and Innovation Action Plan, project no. 17431900100) and Hutchmed Limited.

Disclosure

B. Zhang, M. Shi: Financial Interests, Personal, Full or part-time Employment: Hutchmed Limited. All other authors have declared no conflicts of interest.