Efficacy and safety of tislelizumab as neoadjuvant treatment in patients with stage II-III microsatellite instability-high/mismatch repair-deficient colorectal cancer: a single-arm, multicenter, open-label, prospective, phase II study.
[BACKGROUND] In colorectal cancer (CRC), genomic microsatellite instability (MSI) indicates potential susceptibility to immune checkpoint blockade.
APA
Chen G, Ye Y, et al. (2026). Efficacy and safety of tislelizumab as neoadjuvant treatment in patients with stage II-III microsatellite instability-high/mismatch repair-deficient colorectal cancer: a single-arm, multicenter, open-label, prospective, phase II study.. International journal of surgery (London, England). https://doi.org/10.1097/JS9.0000000000004836
MLA
Chen G, et al.. "Efficacy and safety of tislelizumab as neoadjuvant treatment in patients with stage II-III microsatellite instability-high/mismatch repair-deficient colorectal cancer: a single-arm, multicenter, open-label, prospective, phase II study.." International journal of surgery (London, England), 2026.
PMID
41706635
Abstract
[BACKGROUND] In colorectal cancer (CRC), genomic microsatellite instability (MSI) indicates potential susceptibility to immune checkpoint blockade. Tislelizumab, a programmed cell death protein-1 inhibitor, has shown efficacy in MSI-high (MSI-H)/mismatch repair-deficient (dMMR) metastatic CRC.
[METHODS] This prospective, single-arm phase II study (BGB-A317-214) aimed to evaluate the efficacy and safety of neoadjuvant tislelizumab in stage II-III MSI-H/dMMR CRC. Eligible patients received three cycles of neoadjuvant tislelizumab (200 mg intravenously) every 3 weeks, followed by radical surgery. The primary endpoint was investigator-assessed major pathological response (MPR) rate. Secondary endpoints included investigator-assessed pathological complete response (pCR) rate, event-free survival (EFS), and safety.
[RESULTS] From January 2022 to June 2023, 33 patients were enrolled and received at least one cycle of neoadjuvant tislelizumab, and 29 received radical surgery. At primary analysis (data cutoff: 26 September 2023; median study follow-up: 6.5 [range, 0.9-20.0] months), MPR and pCR rates were 89.7% (26/29 patients) and 62.1% (18/29 patients), respectively. MPR and pCR were consistent across the subgroups, including tumor location and clinical stage. With long-term follow-up (data cutoff: 3 January 2025; median study follow-up: 21.7 [range, 0.9-35.2] months), the median EFS by investigator was not reached. The 1-year and 2-year EFS rates were both 93.9%. The safety profile of tislelizumab was well tolerated with no unexpected safety signals; one patient (3%) had a grade ≥3 treatment-related adverse event (abdominal inflammation). All other treatment-related adverse events were mild to moderate in severity.
[CONCLUSION] This study provides promising preliminary evidence for the efficacy and safety of neoadjuvant tislelizumab in patients with locally advanced MSI-H/dMMR CRC.
[METHODS] This prospective, single-arm phase II study (BGB-A317-214) aimed to evaluate the efficacy and safety of neoadjuvant tislelizumab in stage II-III MSI-H/dMMR CRC. Eligible patients received three cycles of neoadjuvant tislelizumab (200 mg intravenously) every 3 weeks, followed by radical surgery. The primary endpoint was investigator-assessed major pathological response (MPR) rate. Secondary endpoints included investigator-assessed pathological complete response (pCR) rate, event-free survival (EFS), and safety.
[RESULTS] From January 2022 to June 2023, 33 patients were enrolled and received at least one cycle of neoadjuvant tislelizumab, and 29 received radical surgery. At primary analysis (data cutoff: 26 September 2023; median study follow-up: 6.5 [range, 0.9-20.0] months), MPR and pCR rates were 89.7% (26/29 patients) and 62.1% (18/29 patients), respectively. MPR and pCR were consistent across the subgroups, including tumor location and clinical stage. With long-term follow-up (data cutoff: 3 January 2025; median study follow-up: 21.7 [range, 0.9-35.2] months), the median EFS by investigator was not reached. The 1-year and 2-year EFS rates were both 93.9%. The safety profile of tislelizumab was well tolerated with no unexpected safety signals; one patient (3%) had a grade ≥3 treatment-related adverse event (abdominal inflammation). All other treatment-related adverse events were mild to moderate in severity.
[CONCLUSION] This study provides promising preliminary evidence for the efficacy and safety of neoadjuvant tislelizumab in patients with locally advanced MSI-H/dMMR CRC.
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