Updated results from the phase II study: Efficacy and safety of anlotinib plus sintilimab as second-line treatment for patients with advanced biliary tract cancers.

Abstract

577 Background: The incidence rate of biliary tract cancer (BTCs) is gradually increasing in china, while chemotherapy and immune checkpoint inhibitors monotherapy demonstrated limited efficacy for BTCs. New effective regimens are urgently needed. In this study, we explore anlotinib plus sintilimab as a chemo-free combination for second-line therapy. Previous results had been reported in 2021 ASCO GI (307 Poster Session). Updated results for longer follow-up and additional enrollment are presented here. Methods: BTC patients (pts) failed after the first-line treatment, aged 18-75 and an ECOG PS of 0-1 were recruited. Eligible pts received anlotinib (12mg, po, d1-14, q3w) and sintilimab (200mg, iv, d1, q3w) until disease progression, unacceptable toxicity or up to 2 years. The primary endpoint was Overall survival (OS). Secondary endpoints included Objective Response Rate, (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR) and safety. Results: At data cut-off date (Dec 30, 2021), a total of 29 pts were enrolled, of which 20 pts were available for efficacy assessment. The median treatment duration was 5.6 months (IQR: 2.5-10.0), and the median follow-up time was 12.5 months (IQR, 7.1-21.8). The median OS was 12.3 months (95% CI: 10.1-14.5).The median PFS was 6.5 months (95% CI: 4.2-8.8).The ORR was 30% (95% CI: 11.9%-54.3%) and DCR was 95% (95% CI: 75.1%-99.9%). Safety profile exhibited that the regimen was tolerable.The treatment-related adverse events (TRAEs) of any grade occurred in all patients (100%). The most common TRAEs were elevated GGT (75%), followed by hypertension (65%), elevated ALP (65%), elevated D-dimer (65%), elevated ALT (55%), anemia (50%), and elevated AST (50%). Grade 3 TRAEs occurred in 4 (20%) patients, including 2 (10%) hypertension, 1 (5%) elevated GGT, 1 (5%) elevated ALP, 1 (5%) elevated AST and 1 (5%) elevated ALT. No grade 4 or 5 TRAEs were observed. Conclusions: Anlotinib plus sintilimab demonstrated encouraging anti-tumor activity with a tolerable safety profile and deserve to be investigated in randomized trials for patients with advanced BTC. Clinical trial information: 1900022003 .