VigiBase analysis of association between ICI use during pregnancy and outcomes in pregnant individuals and newborns

There is no certainty about the safety of use of immune checkpoint inhibitors (ICIs) for cancer during pregnancy. Analysis of 3558 reports in the WHO VigiBase found that exposure to ICIs (91 reports) was not associated with overreporting of specific adverse pregnancy, fetal, or newborn outcomes compared with exposure to other anticancer treatments (3467 reports), with the exception of overreporting of preterm birth after use of a combination of anti-PD-1 and anti-CTLA-4. The authors conclude that these findings suggest that ICI use during pregnancy may be better tolerated than previously suspected.