Posted: Friday, June 30, 2023
According to a phase II study presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4100), first-line treatment with the monoclonal antibody sintilimab and the tyrosine kinase inhibitor anlotinib added to the chemotherapy regimen of gemcitabine and cisplatin may improve clinical and survival outcomes in patients with advanced biliary tract cancer. The combination therapy outperformed gemcitabine plus cisplatin alone in terms of progression-free survival and objective response rate.
“Sintilimab + anlotinib + gemcitabine/cisplatin may be a new first-line standard-of-care regimen [in this patient population],” according to Li Jingjing, PhD, MD, MPH, of the Chinese Academy of Sciences in Hanzhou, and colleagues.
The phase II trial, known as SAGC, included 48 patients with treatment-naive, unresectable advanced, recurrent, or metastatic biliary tract cancer. Patients were randomly assigned to receive either a maximum of eight cycles of sintilimab and anlotinib plus gemcitabine plus cisplatin followed by sintilimab and anlotinib (n = 26) or a maximum of eight cycles of gemcitabine plus cisplatin (n = 22). Cycles may be halted by disease progression or intolerable toxicity.
Progression-free survival was significantly longer with sintilimab, anlotinib, and chemotherapy than with chemotherapy alone (6.4 months vs. 5.0 months). The overall response rate was also higher with quadruplet regimen recorded at 37.5% versus 26.7% rate with chemotherapy alone. Though the primary objective of 1-year overall survival was not met, a modest trend of improvement was noted with sintilimab, anlotinib, and chemotherapy, according to the investigators.
In terms of toxicity, the rate of grade 3 or 4 treatment-related adverse events was higher with the quadruplet regimen (69.2% vs. 38.7%). However, treatment discontinuation rates attributed to treatment-related adverse events were similar across the arms. Treatment discontinuation occurred in 7.7% of the group given sintilimab, anlotinib, and chemotherapy versus 9.1% of the group given chemotherapy alone.
Disclosure: The study authors reported no conflicts of interest.