SARS-CoV-2 vaccination and phase 1 cancer clinical trials

• Published in: The lancet oncology 2021-03, Vol.22 (3), p.298-301
• Main Authors: Yap, Timothy A, Siu, Lillian L, Calvo, Emiliano, Lolkema, Martijn P, LoRusso, Patricia M, Soria, Jean-Charles, Plummer, Ruth, de Bono, Johann S, Tabernero, Josep, Banerji, Udai
• Format: Article
• Language: English
• Subjects: Antineoplastic drugs; Antitumor agents; Cancer; CD19 antigen; CD20 antigen; Chimeric antigen receptors; Clinical trials; Clinical Trials, Phase I as Topic; Comment; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 Vaccines - immunology; Cytokines; Drug delivery; Drug development; Humans; Immune checkpoint; Immunosuppressive agents; Immunotherapy; Influenza A; Lymphocytes T; Monoclonal antibodies; Morbidity; Mortality; Neoplasms - drug therapy; Pandemics; Patients; PD-1 protein; PD-L1 protein; SARS-CoV-2 - immunology; Seroconversion; Severe acute respiratory syndrome coronavirus 2; Toxicity; Vaccination
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(21)00017-6

[...]a SARS-CoV-2 vaccine is likely to confer reduced protection in patients participating in phase 1 trials of experimental B cell-depleting antitumour drugs, such as monoclonal antibodies targeting CD10, CD19, or CD20, or CD19 chimeric antigen receptor T cells, given that such patients are unlikely to mount an optimal immune response.7 From experience with influenza A vaccinations in patients receiving checkpoint inhibitors targeting PD-1 or PD-L1, seroconversion and seroprotection rates are generally high.8 Toxicity is particularly important when considering the effects of vaccinations on trials that involve IMPs with a high risk of immune adverse events, including cytokine release syndrome, or novel drugs given in combination with immunotherapies. Clearly, such decisions need to be individualised to each patient and IMP risk profile. Because it is currently unclear how long immunity will last after vaccination, with this response likely to be temporary and lasting months to years, rather than decades or a lifetime, repeat vaccinations are likely to be required during a patient's lifetime. SARS-CoV-2 infection has no doubt affected and delayed all components of care for patients with cancer, including screening, diagnosis, treatment, and monitoring and surveillance strategies, and has probably increased the risk of cancer-related morbidity and mortality.9 The pandemic also affects oncology trials, including patient accrual and logistical and economic aspects, and has the potential to affect the long-term development of promising life-saving anticancer drugs.