Abstract 75P
Background
Currently, the efficacy and safety of combining immune checkpoint inhibitors with anti-angiogenic agents as a first-line treatment for metastatic colorectal cancer (mCRC) patients remain undefined. Thus, this study aimed to assess the combination of sintilimab plus anlotinib in patients with treatment-naïve mCRC.
Methods
This is an investigator-initiated, open-label, single-arm, phase II trial conducted in treatment-naïve mCRC patients. Eligible patients were given sintilimab intravenously at a dose of 200 mg on day 1 and anlotinib orally at a dosage of 12 mg daily from days 1–14, every 3 weeks. The primary endpoint was the objective response rate (ORR), assessed by the investigators following Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. The secondary endpoints encompassed disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results
Between June 2020 and September2023, 30 patients eventually enrolled and received the study regimen. Of the 29 patients eligible for efficacy analyses, 1 achieved complete response, 13 exhibited confirmed partial responses. The ORR were 48.3% (95%CI 29.4–67.5) in the efficacy-evaluable cohort and 46.7% (95%CI 28.3–65.7) in the ITT cohort. Thirteen patients had stable disease, and the DCRs were 89.7%, (95%CI 72.6–97.8) and 86.7% (95%CI 69.3–96.2) in efficacy-evaluable and intent-to-treat (ITT) cohorts, respectively. The median PFS was 8.6 months (95%CI 4.8–9.7), and the median OS reached 23.2 months (95%CI 13.6–36.3). Treatment-related adverse events (TRAEs) of any grade were reported in 23 patients (76.7%), and common TRAEs included diarrhea, hypothyroidism, hypertension, and hand-foot syndrome. Grade-3 TRAEs occurred in 4 patients (13.3%), while no grade-4 or -5 TRAEs or treatment-related deaths were observed.
Conclusions
These findings provided the rationale for sintilimab plus anlotinib as a promising chemotherapy-free option for treatment-naïve mCRC patients, with encouraging anticancer activity and lower occurrence rate of adverse events.
Clinical trial identification
NCT04271813.
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.