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

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Abstract

Background

Neoadjuvant immunotherapy with programmed death-ligand 1 blockade for colon cancer, especially for mismatch repair-deficient (dMMR)/high microsatellite instability (MSI-H) colon cancer, has gained considerable attention recently.

Objective

This study aimed to assess the safety and efficacy of neoadjuvant subcutaneous envafolimab in patients with dMMR/MSI-H locally advanced colon cancer.

Methods

Patients with dMMR/MSI-H locally advanced colon cancer treated with envafolimab at Sun Yat-sen University Cancer Center and Yunnan Cancer Hospital from October 2021 to July 2023 were retrospectively reviewed and analyzed. The primary endpoint was the pathological complete response (CR) rate, and secondary endpoints were treatment-related adverse events and complete clinical response rate.

Results

Overall, 15 patients were analyzed. After neoadjuvant immunotherapy with envafolimab, six patients achieved a CR, with five partial responses, and four stable disease. Three patients achieving a complete clinical response chose to accept a “watch and wait” strategy, and surgery was performed in 12 patients. Postoperative pathology results revealed seven patients achieved pathological CRs, and five patients achieved tumor regression grade 2, with 66.7% of the total CR rate. The most common treatment-related adverse events were pruritus and rash (40%), with no severe cases. No recurrences occurred over a 7.9-month follow-up.

Conclusions

Envafolimab yielded promising surgical outcomes and safety in dMMR/MSI-H locally advanced colon cancer, representing a promising treatment modality for this population.

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Acknowledgements

We greatly appreciate the help from all of our colleagues in the Department of Colorectal Surgery at Sun Yat-sen University Cancer Center who were involved in administering the treatments in the current study.

Author information

Author notes

  1. Yuan Li, Weili Zhang, Jie Du, **long Hu and Ruixi Hu contributed equally to this work.

Authors and Affiliations

  1. Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, People’s Republic of China

    Yuan Li, Weili Zhang, Ziyang Zeng, E-er-man-bie-ke **-si-han, Shaopu Lian, Hao Wang, Zhizhong Pan, Cheng Feng & Zhenhai Lu

  2. Department of Colorectal Surgery, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming, 650000, Yunnan, People’s Republic of China

    Jie Du, Ruixi Hu, Yunfeng Li & Xuan Zhang

  3. Department of Pathology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, 510060, Guangdong, People’s Republic of China

    **long Hu

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  1. Yuan Li
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Corresponding authors

Correspondence to Cheng Feng, Xuan Zhang or Zhenhai Lu.

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Funding

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of interest

Yuan Li, Weili Zhang, Jie Du, **long Hu, Ruixi Hu, Ziyang Zeng, E-er-man-bie-ke **-si-han, Shaopu Lian, Hao Wang, Yunfeng Li, Zhizhong Pan, Cheng Feng, Xuan Zhang, and Zhenhai Lu have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

All procedures conducted in studies involving human participants and human materials were approved by the Ethics Committee of Sun Yat-sen University Cancer Center (B2023-188-01). The study strictly adhered to the principles outlined in the Declaration of Helsinki and its subsequent amendments, or comparable ethical standards.

Informed consent

Informed consent was obtained from all patients prior to participating in this study.

Consent for publication

Not applicable.

Availability of data and material

The datasets used and/or analyzed during the current study are available from the corresponding authors on reasonable request. The authenticity of this article has been validated by uploading the key raw data onto the Research Data Deposit public platform (www. researchdata.org.cn), RDD number RDDA2024411157.

Code availability

Not applicable.

Author contributions

Conception and design: ZL, XZ, CF, and YL. Provision of study materials or patients: ZL, XZ, YL, RH, and JD. Collection and assembly of data: JD, LH, and WZ. Data analysis and interpretation: WZ, HW, SL, EEMBKJSH, and ZZ. Manuscript writing: WZ and YL. All authors read and approved the final manuscript.

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Li, Y., Zhang, W., Du, J. et al. Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer. Targ Oncol (2024). https://doi.org/10.1007/s11523-024-01064-x

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