Age Range in POLIVY Clinical Trials
POLIVY (polatuzumab vedotin-piiq), approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), was studied in key trials like GO29365 (Phase 1b/2) and GO29365 (Phase 2 ROMULUS extension). Patients ranged from 18 to 90 years old across these studies.[1][2]
What Was the Median Age and Distribution?
In the pivotal GO29365 trial (n=80), median age was 67 years (range: 29–86). Most patients (73%) were 65 or older; 27% were under 65.[1] ROMULUS showed similar demographics, with median age around 68 and range up to 90.[2]
Were Elderly Patients Included?
Yes, trials enrolled patients up to age 90, reflecting real-world DLBCL demographics where over half of cases occur in those 65+. No upper age cutoff excluded fit elderly patients.[1][3]
Age in Ongoing or Expanded Studies?
Phase 3 POLARIX trial (n=880, bendamustine-free frontline regimen) had a median age of 68 (range: 18–80+), with 43% aged 65–74 and 23% 75+.[4] Pediatric data is absent; approval targets adults 18+.
Why Does Age Matter for POLIVY Use?
Older patients (≥65) faced higher rates of serious adverse events (90% vs. 71% in younger) and cytopenias, but efficacy was consistent across ages.[1][3] Dosing adjustments aren't age-based, but monitoring increases for frailty.
[1]: POLIVY Prescribing Information (Genentech, 2023)
[2]: Sehn et al., Lancet Oncology (2019)
[3]: FDA Approval Summary (2023)
[4]: Tilly et al., NEJM (2022)