Abstract 1247P
Background
Toripalimab, an anti-PD-1 antibody, has shown moderate efficacy in GC/EGJC. Apatinib, a selective inhibitor of VEGFR2, has a synergistic effect with immunotherapy. We aimed to assess the combination of Toripalimab and apatinib as second-line treatment for advanced GC/EGJC.
Methods
We enrolled patients with advanced GC/EGJC progressed after first-line chemotherapy. Patients in experimental arm received 250 mg apatinib orally once daily plus 240 mg toripalimab by intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. In control group, patients received paclitaxel or irinotecan. The primary endpoint was progression-free survival (PFS) and clinical benefit rate at 6 months, which were based on RECIST V.1.1.
Results
52 patients were enrolled between November 21 and July 24, 2021. At data cutoff (February 25, 2022), median follow-up was 15.8 months (IQR 5·0–19·1). 4 (15%) of 26 experimental patients had a confirmed objective response. The grade 3 or worse treatment-related adverse events in controlled group was higher than the experimental group (34.5% vs 23.0%). The most common grade 3 or worse treatment-related adverse events were anemia (20 [76.92%]), hypoalbuminemia (19 [73.08%]). PFS of the controlled group and experimental group was 3.2 and 3.0 months, respectively. No treatment-related deaths occurred.
Conclusions
Although the combination of apatinib and toripalimab seemed to reach comparable PFS in treating advanced GC/EGJC, it did not reach the prespecified target. The moderate AEs indicate that apatinib and toripalimab may be an alternative for second-line therapy.
Clinical trial identification
NCT04190745.
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.