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Preliminary clinical study of personalized neoantigen vaccine therapy for microsatellite stability (MSS)-advanced
Yao-Jun Yu1, Na Shan2, Li-Yi Li1
1Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, People's Republic of China.
Abstract:
Immunotherapy based on immune checkpoint inhibitors (ICIs) has provided revolutionary results in treating various cancers. However, its efficacy in colorectal cancer (CRC), especially in microsatellite stability-CRC, is limited. This study aimed to observe the efficacy of personalized neoantigen vaccine in treating MSS-CRC patients with recurrence or metastasis after surgery and chemotherapy. Candidate neoantigens were analyzed from whole-exome and RNA sequencing of tumor tissues. The safety and immune response were assessed through adverse events and ELISpot. The clinical response was evaluated by progression-free survival (PFS), imaging examination, clinical tumor marker detection, circulating tumor DNA (ctDNA) sequencing. Changes in health-related quality of life were measured by the FACT-C scale. A total of six MSS-CRC patients with recurrence or metastasis after surgery and chemotherapy were administered with personalized neoantigen vaccines. Neoantigen-specific immune response was observed in 66.67% of the vaccinated patients. Four patients remained progression-free up to the completion of clinical trial. They also had a significantly longer progression-free survival time than the other two patients without neoantigen-specific immune response (19 vs. 11 months). Changes in health-related quality of life improved for almost all patients after the vaccine treatment. Our results shown that personalized neoantigen vaccine therapy is likely to be a safe, feasible and effective strategy for MSS-CRC patients with postoperative recurrence or metastasis.
Insights
Personalized neoantigen vaccines show promise for microsatellite stable colorectal cancer (MSS-CRC) patients with recurrent or metastatic disease. This approach demonstrated safety, induced immune responses, and improved progression-free survival in a small trial.
Area of Science:
- Oncology
- Immunology
- Genomics
Background:
- Immune checkpoint inhibitors (ICIs) offer revolutionary cancer treatment but have limited efficacy in microsatellite stable colorectal cancer (MSS-CRC).
- MSS-CRC patients with postoperative recurrence or metastasis face limited treatment options.
Purpose of the Study:
- To evaluate the safety and efficacy of personalized neoantigen vaccines in MSS-CRC patients with recurrent or metastatic disease.
- To assess the immune response and clinical outcomes following neoantigen vaccination.
Main Methods:
- Whole-exome and RNA sequencing identified candidate neoantigens from tumor tissues.
- Safety assessed via adverse events; immune response measured by ELISpot.
- Clinical response evaluated using progression-free survival (PFS), imaging, tumor markers, and ctDNA sequencing.
Main Results:
- Personalized neoantigen vaccines were administered to six MSS-CRC patients.
- A neoantigen-specific immune response was observed in 66.67% of patients.
- Four patients achieved progression-free status, with a significantly longer PFS (19 months vs. 11 months) compared to non-responders.
Conclusions:
- Personalized neoantigen vaccine therapy appears safe and feasible for MSS-CRC patients with postoperative recurrence or metastasis.
- The treatment induced neoantigen-specific immune responses and showed potential for improved clinical outcomes.
- Further investigation is warranted to establish this as an effective strategy for MSS-CRC.
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