RECEIPT OF SARS-COV2 MRNA VACCINE PRIOR TO IMMUNE CHECKPOINT INHIBITOR THERAPY ASSOCIATED WITH SIGNIFICANTLY IMPROVED OVERALL SURVIVAL ACROSS MULTIPLE METASTATIC CANCERS: RESULTS FROM A REAL-WORLD EVIDENCE STUDY
Author(s)
Joseph Tkacz, MS1, Laura C. Moore-Schiltz, PhD2, Yilin Wu, MS3;
1Inovalon, Ellicott City, MD, USA, 2Inovalon, Sr. Director, Shaker Heights, OH, USA, 3Inovalon, Bowie, MD, USA
1Inovalon, Ellicott City, MD, USA, 2Inovalon, Sr. Director, Shaker Heights, OH, USA, 3Inovalon, Bowie, MD, USA
OBJECTIVES: Preliminary evidence was generated in 2025 highlighting that SARS-Cov-2 mRNA vaccination may sensitize malignant tumors to immune checkpoint inhibitors (ICIs). The purpose of this study was to further investigate this relationship across a broad set of advanced cancers among patients in the U.S.
METHODS: This was a retrospective analysis of the 100% Medicare Fee-for-Service claims database spanning 1/1/2020-12/31/2023. Inclusion criteria: 1) diagnostic evidence of bladder cancer, breast cancer, gastric cancer, lung cancer, melanoma, or renal cell carcinoma, 2) diagnostic evidence of metastasis, 3) initiation of ICI therapy <12 months post-metastasis (index date), and 4) continuous enrollment for ≥12 months pre- and ≥1 day post-index. Within each malignancy, patients were segmented into two cohorts: cases: ≥1 claim for the SARS-Cov-2 mRNA vaccine in the 120 days preceding ICI therapy; controls: absence of the SARS-Cov-2 mRNA vaccine in the 120 days preceding and following ICI therapy. Kaplan-Meier estimators and Cox proportional hazards models controlling for demographic/clinical characteristics were fitted to assess survival differences between cohorts.
RESULTS: 1,772 cases and 20,239 controls qualified for the study; 56.5% male, 87.9% White, mean±SD age of 73.7±8.4. Compared to controls, cases presented significantly longer median survival times across all malignancies, with the largest difference observed between melanoma cases/controls (30.2 [95% CI: 18.7, 32.7] vs. 11.7 [11.2, 12.2] months; p<0.001). The mortality rate was significantly lower among the overall case cohort compared to controls (HR=0.74 [0.70, 0.78]; p<0.001), with gastric cancer cases (HR=0.51 [0.39, 0.66]; p<0.001) and bladder cancer cases (HR=0.53 [0.39, 0.73]; p<0.001) demonstrating the greatest reductions in 1-year mortality risk compared to controls.
CONCLUSIONS: Survival was significantly improved among advanced cancer patients initiating ICIs who previously received SARS-Cov-2 mRNA vaccination. Implications are considerable, including potential updates to oncology treatment protocols, to renewed conversations regarding mRNA technology research, which recently received a $500 million reduction in U.S. funding.
METHODS: This was a retrospective analysis of the 100% Medicare Fee-for-Service claims database spanning 1/1/2020-12/31/2023. Inclusion criteria: 1) diagnostic evidence of bladder cancer, breast cancer, gastric cancer, lung cancer, melanoma, or renal cell carcinoma, 2) diagnostic evidence of metastasis, 3) initiation of ICI therapy <12 months post-metastasis (index date), and 4) continuous enrollment for ≥12 months pre- and ≥1 day post-index. Within each malignancy, patients were segmented into two cohorts: cases: ≥1 claim for the SARS-Cov-2 mRNA vaccine in the 120 days preceding ICI therapy; controls: absence of the SARS-Cov-2 mRNA vaccine in the 120 days preceding and following ICI therapy. Kaplan-Meier estimators and Cox proportional hazards models controlling for demographic/clinical characteristics were fitted to assess survival differences between cohorts.
RESULTS: 1,772 cases and 20,239 controls qualified for the study; 56.5% male, 87.9% White, mean±SD age of 73.7±8.4. Compared to controls, cases presented significantly longer median survival times across all malignancies, with the largest difference observed between melanoma cases/controls (30.2 [95% CI: 18.7, 32.7] vs. 11.7 [11.2, 12.2] months; p<0.001). The mortality rate was significantly lower among the overall case cohort compared to controls (HR=0.74 [0.70, 0.78]; p<0.001), with gastric cancer cases (HR=0.51 [0.39, 0.66]; p<0.001) and bladder cancer cases (HR=0.53 [0.39, 0.73]; p<0.001) demonstrating the greatest reductions in 1-year mortality risk compared to controls.
CONCLUSIONS: Survival was significantly improved among advanced cancer patients initiating ICIs who previously received SARS-Cov-2 mRNA vaccination. Implications are considerable, including potential updates to oncology treatment protocols, to renewed conversations regarding mRNA technology research, which recently received a $500 million reduction in U.S. funding.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT1
Topic
Real World Data & Information Systems
Disease
SDC: Oncology, STA: Vaccines