699P - Immunogenicity and reactogenicity of BNT162b2 COVID-19 mRNA vaccine in long-survivor (LS) patients with metastatic lung cancer (mLC) after primary immunization (PV) and booster (BD): COVALENCE study

Background

As COVID-19 will likely became an epidemic disease, vaccination planning will be crucial for LS-mLC receiving anti-cancer therapy (ACT) in order to prolong effective immunity

Methods

According to the timing of BD and Sars-Cov2 infection (Cov-I) during oncological history, LC pts were allocated in three cohorts: A) Cov-I before PV or third BD; B) uninfected who completed PV during ACT; C) uninfected LC who had completed PV before cancer diagnosis and will receive BD after stating of ACT. As control cohorts, we included other cancer patients (mOC pts) who had completed PV and were candidate to BD during myelosuppressive (cohort D) or not-myelosuppressive (cohort E) ACT. The primary endpoints were seroprevalence of IgG Anti-spike-RBD (anti-S IgG) at two pre-defined time-points (T1: +30-90 days after BD; T2: + 6 months +/- 4 weeks after BD). As exploratory endpoint, we compared median pre-vaccination value of four cytokines (IL-6, IL-2R, TNF-α, IL-10) with post-BD values in immunotherapy-treated pts (IT-pts)

Results

Between October 2021 and February 2022, 113 LS-mLC patients were assigned in cohort A (20 pts), in cohort B (61 pts) or in cohort C (32 pts); 55 LS-mOC patients were allocated in cohort D (25 pts) and in cohort E (30 pts). Throughout the Omicron variant spread, 40 pts (24%) experienced Cov-I before T2 evaluation. Anti-S IgG qualitative seropositivity rate was 100% at T1 and 98.8% at T2. After 6-months FU, hybrid immunization (Cov-I before or after BD), was associated with higher median anti-S IgG trier compared to vaccine alone-induced immunity (p = <0.0001). In uninfected pts, median anti-S IgG titre was significantly lower in IT-treated patients compared to non-IT treated patients (p = 0.02); no difference was found when comparing myelosuppressive or not ACT. Among 68 IT-pts, 5 pts (7.3%) showed significant increase (≥ 1.5 fold) of at least two cytokines in post-BD samples, without reporting ir-AE

Conclusions

Administration BDs of COVID-19 mRNA vaccine in LS-mLC pts resulted effective and safe. In IT-pts without recent Cov-I, additional BDs should be considered to prolong serological immunity

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Fondazione Policlinico Universitario A Gemelli-IRCCS.

Funding

Grant Award: Vaccinazione Anti-COVID-19 Nei Pazienti Oncologici, Sponsor: AIOM (Associazione Italiana di Oncologia Medica)/FICOG (Federation of Italian Cooperative Oncology Groups).

Disclosure

All authors have declared no conflicts of interest.