Caution with direct comparison
Direct comparisons across independent studies (e.g., PRIMA and PRIME) are invalid due to heterogeneity in trial populations. Caution should be exercised in interpreting comparative data.
Data from PRIME should be interpreted with the following caveats in mind:
- The patient population in PRIME is different from the population enrolled in PRIMA
- The study was conducted in Chinese patients
- While the BGI HRD assay (BGI Genomics - Shenzhen, China) used in PRIME has received CE-IVDD approval, it has not been clinically validated
- The ZEJULA capsule used in PRIME is independently manufactured by Zai Lab and has the same formulation composition as GSK’s ZEJULA capsule