{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T19:16:11Z","timestamp":1785352571494,"version":"3.55.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"9","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Precis Oncol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Although adjuvant chemotherapy is standard for locally advanced colon cancer, defective mismatch repair (dMMR)\/microsatellite instability (MSI) tumors show high sensitivity to immune checkpoint inhibitors. We aimed to investigate the efficacy of the PD-1 inhibitor prolgolimab in this setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      We conducted phase II nonrandomized open-label clinical trial (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT06428487\">NCT06428487<\/jats:ext-link>\n                      ) in patients with locally advanced colorectal cancer (CRC) and dMMR\/MSI. Prolgolimab (1 mg\/kg) was administered once every 2 weeks, and surgery was performed after 6 months of immunotherapy. In case of surgical treatment refusal, the systemic treatment proceeded for 1 year. The primary end point was the rate of pathologic complete response (pCR, in operated cases) + clinical complete response (cCR, in nonoperated cases). Secondary end points included pCR, major pathologic response (MPR), objective response (ORR) rates, safety, disease-free survival (DFS), and overall survival.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Of the 30 enrolled, 26 (86.6%) patients underwent surgery after the end of immunotherapy. The study met its primary end point, with 17 (56.7%) of 30 patients achieving pCR (n = 16) + cCR (n = 1 as nonoperated case). According to histologic examination, an MPR (TRG 1-2) was observed in 21 (80.8%) of 26 patients, including 16 (61.6%) patients with pCR. Radiographic ORR was 89.7%, and cCR was observed in six cases (20.7%, five patients underwent surgery further). Three patients with low rectal primary tumors refused to undergo a surgical treatment. The median follow-up was 19 months (range, 13-32). The 18-month DFS was 90%: two progressions and one unrelated death were detected. Grade 3-4 immune-related adverse effects were recorded in one (3.3%) patient.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The use of prolgolimab in locally advanced dMMR\/MSI CRC is associated with high rates of pCR and cCR, allowing for further exploration of organ-sparing approaches in these patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/po-25-00602","type":"journal-article","created":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T20:57:33Z","timestamp":1765400253000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":2,"title":["Neoadjuvant Immunotherapy With Prolgolimab in Patients With Locally Advanced Microsatellite Instability\/Defective Mismatch Repair Colorectal Cancer"],"prefix":"10.1200","clinical-trial-number":[{"clinical-trial-number":"nct06428487","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7753-3081","authenticated-orcid":true,"given":"Olesya","family":"Kuznetsova","sequence":"first","affiliation":[{"name":"Federal State Budgetary Institution \u00abNational Medical Research Center of Oncology named after N.N. 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Sechenov First Moscow State Medical University, Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5615-7806","authenticated-orcid":true,"given":"Mikhail","family":"Fedyanin","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Institution \u00abNational Medical Research Center of Oncology named after N.N. Blokhin\u00bb of the Ministry of Health of Russia, Moscow, Russia"},{"name":"State Budgetary Healthcare Institution \u201cMedical Clinical Scientific Center\u201d \u201cKommunarka\u201d of the Moscow Department of Health, Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9289-1247","authenticated-orcid":true,"given":"Zaman","family":"Mamedli","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Institution \u00abNational Medical Research Center of Oncology named after N.N. 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