The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) 2024 has been successfully concluded. CHIATAI TIANQING Pharmaceutical Group's Class 1 innovative drugs Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor), Paianprilizumab (PD-1 inhibitor) and Behmosubaisumab (TQB2450, PD-L1 inhibitor) have been selected to be presented at the poster session this time with a total of 11 studies, which are related to the field of GI tumors with liver metastasis, esophageal cancer, hepatocellular carcinoma, tumors of the biliary tract system, and colorectal cancer.

ALTER-G-001 is a multi-cohort, multi-center phase II study, and updated results from Cohort A were presented at this ASCO GI meeting. Patients in Cohort A were treated with 6 cycles (3 weeks each) of anilotinib (12 mg, po, qd, d1-14, q3w) + oxaliplatin (130 mg/m2, iv, d1, q3w) + capecitabine (850 mg/m2, po, bid, d1-14, q3w), and if liver metastases were not converted to resectable on imaging assessment, after 6 courses of treatment, efficacy was Patients assessed to be in complete remission (CR)/partial remission (PR)/stable disease (SD) were maintained on maintenance therapy with amilorotinib in combination with capecitabine metronomic chemotherapy (500 mg, po, bid, d1-21, q3w) until disease progression or intolerable. The primary endpoint was objective remission rate (ORR, RECIST v1.1), and secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of remission (DOR), rate of conversion of liver metastases, and safety.

As of September 14, 2023, a total of 45 colorectal cancer patients were enrolled in Cohort A. After induction therapy, 8 patients underwent surgery; 23 patients were in the group (10 were on maintenance therapy), with a maximum duration of therapy (DoT) of 13.7 months. 39 patients were evaluable for efficacy, with an ORR of 48.7% and a DCR of 97.4% (19 PRs, 19 SDs. (16 of these SD patients had tumor reduction). Median PFS has not been reached. The incidence of adverse events (TEAEs) occurring during grade ≥3 treatment was 33.3% and consisted primarily of decreased neutrophil count (11.1%), hypertension (6.7%), and decreased platelet count (6.7%).

The study demonstrated that the first-line treatment of colorectal cancer patients with unresectable liver metastases with amlotinib in combination with chemotherapy has favorable efficacy and a manageable safety profile, and may offer a new treatment strategy for this patient population.