Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73:17–48.

PubMed  Google Scholar 

Hampel H, Frankel WL, Martin E, et al. Screening for the Lynch syndrome (hereditary nonpolyposis colorectal cancer). N Engl J Med. 2005;352:1851–60.

CAS  PubMed  Google Scholar 

Sinicrope FA, Chakrabarti S, Laurent-Puig P, et al. Prognostic variables in low and high-risk stage III colon cancers treated in two adjuvant chemotherapy trials. Eur J Cancer. 2021;144:101–12.

CAS  PubMed  Google Scholar 

Tarhini AA, Eads JR, Moore KN, et al. Neoadjuvant immunotherapy of locoregionally advanced solid tumors. J Immunother Cancer. 2022;10: e005036.

PubMed  PubMed Central  Google Scholar 

Morton D, Seymour M, Magill L, et al. Preoperative chemotherapy for operable colon cancer: mature results of an international randomized controlled trial. J Clin Oncol. 2023;41:1541.

CAS  PubMed  PubMed Central  Google Scholar 

Jung F, Lee M, Doshi S, et al. Neoadjuvant therapy versus direct to surgery for T4 colon cancer: meta-analysis. Br J Surg. 2021;109:30–6.

PubMed  Google Scholar 

Gosavi R, Chia C, Michael M, et al. Neoadjuvant chemotherapy in locally advanced colon cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2021;36:2063–70.

PubMed  Google Scholar 

André T, Shiu KK, Kim TW, et al. Pembrolizumab in microsatellite-instability-high advanced colorectal cancer. N Engl J Med. 2020;383:2207–18.

PubMed  Google Scholar 

Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357:409–13.

CAS  PubMed  PubMed Central  Google Scholar 

Cohen R, Taieb J, Fiskum J, et al. Microsatellite instability in patients with stage III colon cancer receiving fluoropyrimidine with or without oxaliplatin: an ACCENT pooled analysis of 12 adjuvant trials. J Clin Oncol. 2021;39:642.

CAS  PubMed  Google Scholar 

Huang AC, Orlowski RJ, Xu XW, et al. A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma. Nat Med. 2019;25:454.

CAS  PubMed  PubMed Central  Google Scholar 

Schmid P, Cortes J, Dent R, et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556–67.

CAS  PubMed  Google Scholar 

Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med. 2022;386:1973–85.

CAS  PubMed  PubMed Central  Google Scholar 

Agostinetto E, Gligorov J, Piccart M. Systemic therapy for early-stage breast cancer: learning from the past to build the future. Nat Rev Clin Oncol. 2022;19:763–74.

CAS  PubMed  PubMed Central  Google Scholar 

van der Valk MJM, Hilling DE, Bastiaannet E, et al. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study. Lancet. 2018;391:2537–45.

PubMed  Google Scholar 

Chalabi M, Fanchi LF, Dijkstra KK, et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020;26:566.

CAS  PubMed  Google Scholar 

Chalabi M, Verschoor YL, van den Berg J, et al. Neoadjuvant immune checkpoint inhibition in locally advanced MMR-deficient colon cancer: the NICHE-2 study. Ann Oncol. 2022;33:S1389.

Google Scholar 

Hu HB, Kang L, Zhang JW, et al. Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (P1CC): a single-centre, parallel-group, noncomparative, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2022;7:38–48.

PubMed  Google Scholar 

Cercek A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch repair-deficient, locally advanced rectal cancer. N Engl J Med. 2022;386:2363–76.

CAS  PubMed  PubMed Central  Google Scholar 

Zhang F, Wei H, Wang X, et al. Structural basis of a novel PD-L1 nanobody for immune checkpoint blockade. Cell Discov. 2017;3:17004.

PubMed  PubMed Central  Google Scholar 

Papadopoulos KP, Harb W, Peer CJ, et al. First-in-human phase I study of envafolimab, a novel subcutaneous single-domain anti-PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2021;26:e1514–25.

CAS  PubMed  PubMed Central  Google Scholar 

Shimizu T, Nakajima TE, Yamamoto N, et al. Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors. Invest New Drugs. 2022;40:1021–31.

CAS  PubMed  Google Scholar 

Li J, Deng Y, Zhang W, et al. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021;14:95.

CAS  PubMed  PubMed Central  Google Scholar 

von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147:573–7.

Google Scholar 

Mandard AM, Dalibard F, Mandard JC, et al. Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma: clinicopathologic correlations. Cancer. 1994;73:2680–6.

CAS  PubMed  Google Scholar 

Duffaud F, Therasse P. New guidelines to evaluate the response to treatment in solid tumors. Bull Cancer. 2000;87:881–6.

CAS  PubMed  Google Scholar 

Wang DY, Salem JE, Cohen JV, et al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol. 2018;4:1721–8.

PubMed  PubMed Central  Google Scholar 

Diaz LA Jr, Shiu KK, Kim TW, et al. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022;23:659–70.

CAS  PubMed  PubMed Central  Google Scholar 

Overman MJ, McDermott R, Leach JL, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017;18:1182–91.

CAS  PubMed  PubMed Central  Google Scholar 

Ludford K, Ho WJ, Thomas JV, et al. Neoadjuvant pembrolizumab in localized microsatellite instability high/deficient mismatch repair solid tumors. J Clin Oncol. 2023;41:2181–90.

CAS  PubMed  PubMed Central  Google Scholar 

Zhang X, Yang RF, Wu T, et al. Efficacy and safety of neoadjuvant monoimmunotherapy with PD-1 inhibitor for dMMR/MSI-H locally advanced colorectal cancer: a single-center real-world study. Front Immunol. 2022;13:913483.

Eefsen RL, Larsen JS, Klarskov LL, et al. Therapy with pembrolizumab in treatment-naive patients with nonmetastatic, mismatch repair deficient colorectal cancer. Int J Cancer. 2023;152:2145–52.

CAS  PubMed  Google Scholar 

Xiao BY, Zhang X, Cao TY, et al. Neoadjuvant immunotherapy leads to major response and low recurrence in localized mismatch repair-deficient colorectal cancer. J Natl Compr Canc Netw. 2023;21:60-66.e5.

CAS  PubMed  Google Scholar 

Han K, Tang JH, Liao LE, et al. Neoadjuvant immune checkpoint inhibition improves organ preservation in T4bM0 colorectal cancer with mismatch repair deficiency: a retrospective observational study. Dis Colon Rectum. 2023;66:e996-1005.

PubMed  Google Scholar 

Chakrabarti S, Grewal US, Vora KB, et al. Outcome of patients with early-stage mismatch repair deficient colorectal cancer receiving neoadjuvant immunotherapy: a systematic review. JCO Precis Oncol. 2023;7: e2300182.

PubMed  Google Scholar 

Burton S, Brown G, Bees N, et al. Accuracy of CT prediction of poor prognostic features in colonic cancer. Br J Radiol. 2008;81:10–9.

CAS  PubMed  Google Scholar 

Dighe S, Swift I, Magill L, et al. Accuracy of radiological staging in identifying high-risk colon cancer patients suitable for neoadjuvant chemotherapy: a multicentre experience. Colorectal Dis. 2012;14:438–44.

CAS  PubMed  Google Scholar 

Hirose K, Oki E, Shimose T, et al. Comparison of computed tomography imaging analyses for evaluation after chemotherapy in patients with colorectal cancer: a retrospective pooled analysis of six phase II clinical trials. Int J Clin Oncol. 2019;24:1397–405.

PubMed  Google Scholar 

Dam C, Lund-Rasmussen V, Ploen J, et al. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015;62:A5103.

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