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Anlotinib Plus Toripalimab Shows Promising Efficacy, Safety as Second-Line Treatment for Gastric and GEJ Carcinoma
The combination treatment of anlotinib, an oral multi-targeting tyrosine kinase inhibitor (TKI), with toripalimab, a novel anti-PD-1 antibody that binds to the FG loop of the PD-1 receptor, showed promising efficacy and tolerable safety as a second-line treatment for patients with advanced, relapsed gastric or gastroesophageal junction (GEJ) carcinoma.
The single-center, open-label phase 2 trial enrolled 62 patients with relapsed gastric and GEJ carcinoma by the data cutoff date of December 31, 2020. All patients received toripalimab plus anlotinib, with treatment continuing until an investigator determined the patient developed tolerance, or confirmed disease progression.
The primary end points of the study were objective response rate (ORR) and safety. Secondary end points included progression-free survival (PFS) and the correlation of potential biomarkers with clinical efficacy.
The ORR was 32.3% (95% confidence interval [CI], 26.6% to 38.5%) with 20 patients (32.3%) achieving partial response, and 37 patients (59.7%) achieving stable disease. The PFS was 4 months (95% CI, 3.2 to 4.8 months). The most common treatment-related adverse events were fatigue, hypertension, pruritus, and leukopenia. There were 7 patients (11.3%) that experienced grade 3 treatment-related adverse events (proteinuria, thrombocytopenia, hypertension). There were no grade 4/5 treatment-related adverse events and no treatment-related deaths.
The study authors also noted that PD-L1 expression, tumor mutational burden, and FGFR2 mutation may be potential biomarkers for predicting therapeutic efficacy in this regimen.
Source:
Jiang M, Zhang C, Hu Y, et al. Anlotinib combined with toripalimab as second-line therapy for advanced, relapsed gastric or gastroesophageal junction carcinoma. Oncologist. Published online July 20, 2022. doi:10.1093/oncolo/oyac136
