164P - Efficacy and safety of anlotinib plus toripalimab as first-line regimen in advanced gastric cancer patients with performance status 2 (PS 2): An open-label, single arm, phase II trial

Background

Chemotherapy combination strategy is the standard first-line treatment for advanced gastric cancer (AGC) patients with PS 0-1. AGC patients with PS 2 have poor tolerance to standard chemotherapy. Therefore, a well-tolerance chemotherapy-free regimen is urgently needed for AGC patients with PS 2. Thus, this trial was designed to assess the efficacy and safety of multi target TKI Anlotinib plus PD-1 inhibitor Toripalimab in treatment-naïve advanced gastric cancer patients with PS 2.

Methods

This is an investigator-initiated, open-label, single-arm, Simon’s Two Stage, phase II trial. Eligible patients were given Anlotinib orally at a dosage of 12 mg daily from days 1–14 and Toripalimab intravenously at a dose of 240 mg on day 1, every 3 weeks. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results

Between April 24^th, 2020 and July 1^st, 2024, 24 patients(pts) were enrolled and received at least one dose of the treatment regimen. Median age was 67.5 years (range 41-89), male 83.3%, ECOG PS 2 100%. At the data cut-off date (July 4th, 2024), 22 pts eligible for efficacy analyses, 12 achieved partial response, 9 had stable disease. The ORR was 54.5% (95%CI 32.2–75.6) , the DCR was 95.5%(95%CI 77.2–99.9). The median PFS was 7.33 months (95%CI 4.73–17.1), and the median OS reached 15.9 months (95%CI 7.73–23.2). Subgroup analysis showed that older pts (>65yr) could obtain more clinical benefit from this regimen than younger pts (≤65yr) (mPFS: 15.1 vs. 3.83m, P=0.01; mOS: 22.1 vs. 7.72m, P=0.02). Treatment-related adverse events (TRAEs) of any grade were reported in 21 pts (87.5%).Grade 3 TRAEs were alanine aminotransferase (ALT) or aspertate aminotransferase (AST) elevation(16.67%) and myelosuppression(12.50%), and no ≥grade-4 TRAEs or treatment-related deaths were observed.

Conclusions

This trial yielded the rationale for anlotinib plus toripalimab as a promising chemotherapy-free option for the first-line treatment of advanced gastric cancer with PS 2, with encouraging anti-cancer activity and manageable toxicity.

Clinical trial identification

NCT04271813.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.